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The Human Medicines Regulations 2012

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The Human Medicines Regulations 2012 is up to date with all changes known to be in force on or before 17 April 2026. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.

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Statutory Instruments

2012 No. 1916

Medicines

The Human Medicines Regulations 2012

Made

19th July 2012

Laid before Parliament

24th July 2012

Coming into force

14th August 2012

The Secretary of State and the Minister for Health, Social Services and Public Safety make the following Regulations. They do so in exercise of the powers conferred by section 2(2) and (5) of the European Communities Act 1972M1, having been designated for the purposes of section 2(2) of that Act in relation to medicinal productsM2 and to measures in the veterinary and phytosanitary fields for the protection of public healthM3. They do so in exercise also of the powers conferred by sections 87(1), 88(1) and (2), 91(2), and 129(1), (2) and (5) of the Medicines Act 1968M4, having consulted such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations in accordance with section 129(6) of that Act.

Modifications etc. (not altering text)

Marginal Citations

M11972 c.68. Section 2(2) was amended by section 27(1)(a) of the Legislative Reform Act 2006 (2006 c,51) and section 3(3) of and Part 1 of the Schedule to the European Union (Amendment) Act 2008 (2008 c.7). Section 2(5) was amended by section 41(1) of and Part 1 of Schedule 6 to the Northern Ireland Constitution Act 1973 (1973 c.36).

PART 1U.K.General

Citation and commencementU.K.

1.—(1) These Regulations may be cited as the Human Medicines Regulations 2012.

(2) These Regulations come into force on 14th August 2012.

Medicinal productsU.K.

2.—(1) In these Regulations “medicinal product” means—

(a)any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or

(b)any substance or combination of substances that may be used by or administered to human beings with a view to—

(i)restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or

(ii)making a medical diagnosis.

(2) These Regulations do not apply to—

(a)whole human blood; or

(b)any human blood component, other than plasma prepared by a method involving an industrial process.

Modifications etc. (not altering text)

C2Reg. 2 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

[F1Definition of advanced therapy medicinal product etc.U.K.

2A.—(1) In these Regulations F2... “advanced therapy medicinal product” means any of the following products—

(a)a gene therapy medicinal product;

(b)a somatic cell therapy medicinal product; or

(c)a tissue engineered product.

(2) A “gene therapy medicinal product” is a biological medicinal product which has the following characteristics—

(a)it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence; and

(b)its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence.

(3) A vaccine against infectious diseases is not to be treated as a gene therapy medicinal product.

(4) A “somatic cell medicinal product” is a medicinal product which has the following characteristics—

(a)it contains or consists of cells or tissues that—

(i)have been subject to substantial manipulation so that biological characteristics, physiological functions or structural properties relevant for the intended clinical use have been altered, or

(ii)are not intended to be used for the same essential function in the recipient as in the donor; and

(b)it is presented as having properties for, or is used in or administered to human beings with a view to, treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues.

(5) A “tissue engineered product” is a medicinal product which—

(a)contains or consists of engineered cells or tissues; and

(b)is presented as having properties for, or is used in or administered to human beings with a view to, regenerating, repairing or replacing a human tissue.

(6) A tissue engineered product may contain—

(a)cells or tissues of human or animal origin;

(b)viable or non-viable cells or tissues; and

(c)additional substances, including cellular products, bio-molecules, biomaterials, chemical substances, scaffolds or matrices.

(7) A product is not a tissue engineered product if it—

(a)contains or consists exclusively of non-viable human or animal cells or tissues;

(b)does not contain any viable cells or tissues; and

(c)does not act principally by pharmacological, immunological or metabolic action.

(8) Cells or tissues are engineered if they—

(a)have been subject to substantial manipulation, so that biological characteristics, physiological functions or structural properties relevant for the intended regeneration, repair or replacement are achieved; or

(b)are not intended to be used for the same essential function in the recipient as in the donor.

(9) The following manipulations are not substantial manipulations for the purposes of paragraphs (4)(a) and (8)(a)—

(a)cutting;

(b)grinding;

(c)shaping;

(d)centrifugation;

(e)soaking in antibiotic or antimicrobial solutions;

(f)sterilisation;

(g)irradiation;

(h)cell separation, concentration or purification;

(i)filtering;

(j)lyophilisation;

(k)freezing;

(l)cryopreservation; and

(m)vitrification.

(10) In these Regulations F3... “combined advanced therapy medicinal product” means an advanced therapy medicinal product—

(a)which incorporates, as an integral part of the product, one or more medical devices or one or more active implantable medical devices; and

(b)the cellular part of which—

(i)contains viable cells or tissues; or

(ii)contains non-viable cells or tissues which are liable to act upon the human body with action that can be considered as primary to that of the medical devices.

(11) Where an advanced therapy medicinal product contains viable cells or tissues, the pharmacological, immunological or metabolic action of those cells or tissues is to be treated as the principal mode of action of the product.

(12) An advanced therapy medicinal product containing both autologous and allogeneic cells or tissues is to be treated as being for allogeneic use.

(13) A product which falls within the definition of a tissue engineered product and within the definition of a somatic cell therapy medicinal product is to be treated as a tissue engineered product.

(14) A product which falls within the definition of—

(a)a somatic cell therapy medicinal product or a tissue engineered product; and

(b)a gene therapy medicinal product,

is to be treated as a gene therapy medicinal product.]

Textual Amendments

Scope of these Regulations: special provisionsU.K.

3.—(1) Regulation 17(1) (manufacturing of medicinal products: requirement for licence) shall not apply in circumstances where paragraph (4) applies.

(2) Regulations 17(1) (manufacturing of medicinal products: requirement for licence) and 46 (requirement for authorisation) shall not apply in circumstances where paragraph (5) [F4, (5A)] [F5, (5B)] or (6) applies.

(3) These Regulations do not apply where paragraph (7) applies.

(4) This paragraph applies where a medicinal product is assembled by a registered nurse or a registered midwife if—

(a)the nurse or midwife is acting in the course of his or her profession; and

(b)the conditions in paragraphs (8) and (9) are met.

(5) This paragraph applies where a medicinal product is manufactured or assembled by a doctor or dentist and the conditions in paragraphs (8) and (9) are met.

[F6(5A) This paragraph applies where a medicinal product is assembled in a registered pharmacy on behalf of a doctor with a view to its supply as part of arrangements of the type mentioned in regulation 222A(1)(b), where—

(a)an order for the supply of that medicinal product to or for the use of a particular patient was submitted by or on behalf of the doctor as part of the provision of NHS pharmaceutical services; and

(b)the condition in paragraph (8) is met.]

[F7(5B) This paragraph applies where a medicinal product is manufactured or assembled by a pharmacist—

(a)who is acting in the course of his or her profession; and

(b)where—

(i)the conditions in paragraphs (8) and (9) are met, and

(ii)treatment of the patient with the medicinal product is a treatment decision of the pharmacist.]

(6) This paragraph applies where a herbal medicinal product is manufactured or assembled by a person (“A”) if—

(a)the manufacture or assembly takes place on premises occupied by A and from which A can exclude the public;

(b)the product is for administration to a person (“B”) and A has been requested by or on behalf of B, and in B's presence, to use A's judgment as to the treatment required;

(c)the product does not contain a substance specified in Part 1 of Schedule 20;

(d)the product does not contain a substance listed in Part 2 of that Schedule, unless the product is sold or supplied—

(i)in or from containers or packages labelled to show a dose not exceeding the maximum dose or maximum daily dose specified in column 2 of that Part, or

(ii)in the case of a product for external use only, with a percentage of the substance in the product that does not exceed the percentage specified in column 3 of that Part; and

(e)the condition in paragraph (9) is met.

(7) This paragraph applies where the product is a radionuclide that is in the form of a sealed source.

(8) This condition is that the medicinal product is supplied—

(a)to a patient in the course of the treatment of that patient; or

(b)in a case to which paragraph (5) applies, to a patient of another doctor or dentist who is a member of the same medical or dental practice.

(9) This condition is that the medicinal product is not manufactured or, as the case may be, assembled—

(a)on a large scale; or

(b)by an industrial process.

(10) Chapter 1 of Part 13 (requirements for packaging and package leaflets relating to medicinal products) does not apply to a medicinal product that is sold or supplied in circumstances where paragraph (11) [F8, (11A)] or (12) applies in relation to the product, except to the extent set out in paragraph (14), but the requirements of paragraph (13) shall apply.

(11) This paragraph applies where a medicinal product is the result of a process of manufacture to which regulation 17(1) does not apply by virtue of paragraph (5) [F9, (5B)] or (6).

[F10(11A) This paragraph applies where a medicinal product is the result of a process of assembly to which regulation 17(1) does not apply by virtue of paragraph (5A).]

(12) This paragraph applies in the case of a medicinal product where—

(a)the product is the result of a process of assembly of an authorised medicinal product;

(b)regulation 17(1) does not apply to the process of assembly by virtue of paragraph (4) [F11, (5) [F12, (5A) or (5B)]];

(c)the process of assembly results in a change in the presentation of the authorised medicinal product; and

(d)by reason of that change the product so assembled is not sold or supplied in accordance with the terms of—

(i)the [F13UK] marketing authorisation,

F14(ia). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(ii)the certificate of registration,

(iii)the traditional herbal registration, or

(iv)the Article 126a authorisation,

that relates to the authorised medicinal product.

(13) The information specified in Part 1 of Schedule 26 must appear on the outer packaging, or, if there is no outer packaging, on the immediate packaging of a medicinal product that is sold or supplied in circumstances—

(a)where paragraph (11) applies to the product, except in the case of a product manufactured in accordance with paragraph (6); or

(b)where paragraph (12) applies in relation to the product.

(14) Regulations 269 (offences relating to packaging and package leaflets: other persons) and 271 (offences: penalties) shall have effect in relation to paragraph (13) as if that paragraph were a requirement of Part 13.

(15) For the purposes of this regulation and regulation 4 (special provisions for pharmacies etc), a medicinal product is authorised if there is in force for the product—

(a)a [F15UK] marketing authorisation;

F16(aa). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)a certificate of registration;

(c)a traditional herbal registration; or

(d)an Article 126a authorisation.

Textual Amendments

F12Words in reg. 3(12)(b) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 3(5)

[F17Preparation and assembly of medicinal products used for [F18vaccination against an infectious disease] or in the reformulation of such productsU.K.

3A.—F19(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F20(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) Regulation 17(1) does not apply in circumstances where a medicinal product used [F21under relevant arrangements for vaccination against an infectious disease] is labelled by a holder of a wholesale dealer’s licence to take account of a change to the shelf life of the product because of the thawing of the product.

(4) Chapter 1 of Part 13 (requirements for packaging and package leaflets relating to medicinal products)—

F22(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)is to be construed as permitting labelling in accordance with paragraph (3), in the case of a product which is otherwise labelled in accordance with that Part.

(5) For the purposes of this regulation—

F23...

“relevant arrangements” has the meaning given in regulation 19(4C) (exemptions from requirement for wholesale dealer’s licence).

F24(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Textual Amendments

F18Words in reg. 3A heading substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(2)

F23Words in reg. 3A(5) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(6)

Special provisions for pharmacies etcU.K.

4.—(1) Regulations 17(1) (manufacturing of medicinal products: requirement for licence) and 46 (requirement for authorisation) do not apply where any provision of section 10 of the Medicines Act 1968 M5 so provides.

(2) Chapter 1 of Part 13 (requirements for packaging and package leaflets relating to medicinal products) does not apply to a medicinal product that is sold or supplied in circumstances where paragraph (3) or (4) applies in relation to the product, except to the extent set out in paragraph (6), but the requirements of paragraph (5) shall apply.

(3) This paragraph applies in a case where a medicinal product is the result of a process of manufacture to which regulation 17(1) does not apply by virtue of any provision of section 10 of the Medicines Act 1968.

(4) This paragraph applies in the case of a medicinal product where—

(a)the product is the result of a process of assembly of a medicinal product that is an authorised medicinal product within the meaning of regulation 3(15);

(b)regulation 17(1) does not apply to the process of assembly by virtue of any provision of section 10 of the Medicines Act 1968;

(c)the process of assembly results in a change in the presentation of the authorised medicinal product; and

(d)by reason of that change the product so assembled is not sold or supplied in accordance with the terms of—

(i)the [F25UK] marketing authorisation,

F26(ia). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(ii)the certificate of registration,

(iii)the traditional herbal registration, or

(iv)the Article 126a authorisation,

that relates to the authorised medicinal product.

(5) The information specified in Part 2 of Schedule 26 must appear on the outer packaging, or, if there is no outer packaging, on the immediate packaging of a medicinal product that is sold or supplied in circumstances where paragraph (3) or (4) applies in relation to the product.

(6) Regulations [F27269 (offences relating to packaging and package leaflets in Great Britain: other persons), 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons)] and 271 (offences: penalties) shall have effect in relation to paragraph (5) as if that paragraph were a requirement of Part 13.

Textual Amendments

Marginal Citations

M5Section 10(1) was amended by paragraph 10(a) of Part 1 of Schedule 8 to S.I. 2006/2407, paragraph 5(a) of Schedule 3 to the Regulation of Care (Scotland) Act 2001, and article 3 of S.I. 1971/1445. Section 10(2) was repealed by paragraph 10(b) and (3)(b) was repealed by paragraph 10(c) of Part 1 of Schedule 8 to S.I. 2006/2407. Section 10(4) was amended and section 10(5) and (6) inserted by article 3 of S.I. 1971/1445. Section 10(6A) was repealed by paragraph 10(d) of Part 1 of Schedule 8 to S.I. 2006/2407. Section 10(7) was inserted by article 3 of S.I. 1971/1445, and amended by regulation 3 of S.I. 1993/834. Section 10(7A) to (7C) was inserted by the Health Act 2006 section 26(1), and section 10(7A) was amended by paragraph 10(e) of Part 1 of Schedule 8 to S.I. 2006/2407. Section 10(8) was inserted by S.I. 1971/1445 article 3. Section 10(9) was inserted by paragraph 5(a) of Schedule 3 to the Regulation of Care (Scotland) Act 2001.

Classification of medicinal productsU.K.

5.—(1) In these Regulations references to a medicinal product subject to general sale are to a product that is not a prescription only medicine or a pharmacy medicine but is—

(a)a product that is covered by an authorisation of which it is a term that the product is to be available on general sale[F28.]

F29(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) In paragraphs (1)(a) and (5)(a) “authorisation” means—

(a)a UK marketing authorisation;

(b)a certificate of registration;

(c)a traditional herbal registration; or

(d)[F30in the case of a medicinal product for sale or supply in Northern Ireland,] an Article 126a authorisation.

(3) In these Regulations references to a prescription only medicine are to any of the following—

(a)a medicinal product that is covered by an authorisation of which it is a term that the product is to be available only on prescription;

F31(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)a medicinal product that is a prescription only medicine by virtue of Part 1 of Schedule 1; or

(d)a medicinal product that is the result of—

(i)the assembly, or

(ii)the reformulation (including the combining with other substances),

of a medicinal product that is a prescription only medicine by virtue of sub-paragraph (a) F32....

(4) In paragraph (3)(a) “authorisation” means—

(a)a UK marketing authorisation; or

(b)[F33in the case of a medicinal product for sale or supply in Northern Ireland [F34(that is not a listed NIMAR product)],] an Article 126a authorisation.

(5) In these Regulations references to a pharmacy medicine are to a medicinal product that is not a prescription only medicinal product or a medicinal product subject to general sale but is—

(a)covered by an authorisation of which it is a term that the product is to be available only from a pharmacy;

F35(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)available only from a pharmacy by virtue of Part 2 of Schedule 1; or

(d)the result of—

(i)the assembly, or

(ii)the reformulation (including the combining with other substances),

of a medicinal product that is a pharmacy medicine by virtue of sub-paragraph (a) F36....

Textual Amendments

The licensing authority and the MinistersU.K.

6.—(1) The licensing authority is responsible for the grant, renewal, variation, suspension and revocation of licences, authorisations, certificates [F37, designations, opinions] and registrations under these Regulations.

(2) In these Regulations “the licensing authority” means either or both of the Ministers.

(3) Any function that—

(a)is conferred on “the licensing authority” by these Regulations; or

(b)is a function within paragraph (4),

may be exercised by either of the Ministers acting alone or by both of them acting jointly.

(4) The functions of a member State, or of the competent authority of a member State, under any of the relevant EU provisions are to be exercised by the licensing authority if—

(a)they relate to medicinal products; and

(b)they are to be exercised by, or by any authority of, the United Kingdom.

(5) Paragraph (4) does not apply to any function that is conferred by these Regulations on a person or body other than the licensing authority.

(6) In these Regulations “the Ministers” means—

(a)the Secretary of State; and

(b)the Minister for Health, Social Services and Public Safety.

(7) Any function that is conferred on “the Ministers” by these Regulations is to be exercised by the Ministers acting jointly.

(8) Paragraph (7) does not apply where these Regulations provide for a function of the Ministers to be exercised by either of them acting alone or both of them acting jointly.

Textual Amendments

Advertisements relating to medicinal productsU.K.

7.—(1) In these regulations “advertisement”, in relation to a medicinal product, includes anything designed to promote the prescription, supply, sale or use of that product.

(2) This includes, in particular, the following activities—

(a)door-to-door canvassing;

(b)visits by medical sales representatives to persons qualified to prescribe or supply medicinal products;

(c)the supply of samples;

(d)the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except where the intrinsic value of such inducements is minimal;

(e)the sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products; and

(f)the sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products, including the payment of their travelling and accommodation expenses in that connection.

(3) But references in these Regulations to an “advertisement” do not include any of the following—

(a)a medicinal product's package or package leaflet;

(b)reference material and announcements of a factual and informative nature, including—

(i)material relating to changes to a medicinal product's package or package leaflet,

(ii)adverse reaction warnings,

(iii)trade catalogues, and

(iv)price lists,

provided that no product claim is made; or

(c)correspondence, which may be accompanied by material of a non-promotional nature, answering a specific question about a medicinal product.

(d)In this regulation “person qualified to prescribe or supply medicinal products” has the meaning given in regulation 277(1) (interpretation: Part 14 advertising).

General interpretationU.K.

8.—(1) In these Regulations (unless the context otherwise requires)—

[F38“the 2001 Directive” means Directive 2001/83/EC of the European Parliament and of the Council on the Community Code relating to medicinal products for human use;]

[F39“the 2018 Regulations” means the Health Service Products (Provision and Disclosure of Information) Regulations 2018;]

[F40“active implantable medical device”—

(a)

has the meaning given in regulation 2 of the Medical Devices Regulations 2002; or

(b)

to the extent necessary for the practical application of that definition, also or instead has the meaning given in regulation 137 of those Regulations;]

[F41“active substance” means any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis;]

“administer” means administer to a human being—

(a)

orally, by injection, or by introduction into the body in any other way; or

(b)

by external application (whether or not by direct application to the body),

and any reference in these Regulations to administering anything is to administering it in its existing state or after it has been dissolved or dispersed in, or diluted or mixed with, a substance used as a vehicle;

F42...

“adverse reaction” means a response to a medicinal product that is noxious and unintended;

“advisory body” has the meaning given by regulation 12(1);

[F40“agreed paediatric investigation plan” means a paediatric investigation plan which the licensing authority has agreed in accordance with regulation 50B;]

[F40“Annex I to the 2001 Directive” means, in relation to UKMA(GB) [F43or UKMA(UK)(Category 1)], Annex I to the 2001 Directive, as modified in accordance with Schedule 8B;]

[F40“approved country for batch testing list” means the list published by the licensing authority under paragraph 14(3) of Schedule 7 (obligations of qualified persons) and “approved country for batch testing” means a country included in that list;]

[F40“approved country for import list” means the list published by the licensing authority under regulation 18A (approved country for import) and “approved country for import” means a country included in that list;]

“appropriate practitioner” means an appropriate practitioner within the meaning of regulation 214;

“Article 126a authorisation” means an authorisation granted by the licensing authority under Part 8 of these Regulations;

[F44“assemble”, in relation to a medicinal product or an active substance, includes the various processes of dividing up, packaging and presentation of the product or substance, and “assembly” has a corresponding meaning;]

“biological medicinal product” and “biological substance” have the meaning given in the third indent of paragraph 3.2.1.1.(b) of Annex I to the 2001 Directive;

“blood component” means any of the following—

(a)

red cells;

(b)

white cells;

(c)

platelets; and

(d)

plasma;

“the British Pharmacopoeia” means the British Pharmacopoeia referred to in regulation 317;

[F45“brokering” means all activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person;]

“business” includes—

(a)

a professional practice;

(b)

any activity carried on by a body of persons whether corporate or unincorporated; and

(c)

the provision of services by or on behalf of the Secretary of State, the Minister for Health, Social Services and Public Safety, the Welsh Ministers or the Scottish Ministers as the case may be under the following enactments—

(i)

the National Health Service Act 2006 M6,

(ii)

the Health and Personal Social Services (Northern Ireland) Order 1972 M7 and the Health and Social Care (Reform) Act (Northern Ireland) 2009 M8,

(iii)

the National Health Service (Wales) Act 2006 M9,

(iv)

the National Health Service (Scotland) Act 1978 M10;

F46...

“certificate of registration” means a certificate of registration granted by the licensing authority under Part 6 of these Regulations [F47and—

(a)

“COR(UK)” means such a certificate in force in the whole United Kingdom;

(b)

“COR(GB)” means such a certificate in force in Great Britain only;

(c)

“COR(NI)” means such a certificate in force in Northern Ireland only;]

“clinical management plan” means a written plan relating to the treatment of an individual patient and agreed by—

(a)

the patient;

(b)

the doctor or dentist who is a party to the plan; and

(c)

any supplementary prescriber who is to prescribe, give directions for administration or administer under the plan;

“clinical trial” has the meaning given by regulation 2 of the Clinical Trials Regulations;

“the Clinical Trials Directive” means Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use M11;

“the Clinical Trials Regulations” means the Medicines for Human Use (Clinical Trials) Regulations 2004 M12;

“the Commission” has the meaning given by regulation 9(1);

F48...

“common name” in relation to a medicinal product, active substance or excipient means—

(a)

its international non-proprietary name recommended by the World Health Organisation; or

(b)

if such a name does not exist, its usual common name;

[F40“the Committee for Medicinal Products for Human Use” means the committee established under Article 5(1) of Regulation (EC) No 726/2004;]

[F40“conditional marketing authorisation” means a [F49UKMA(UK)(Category 1)] granted under regulation 49(1)(a) in accordance with regulation 58F;]

“community practitioner nurse prescriber” means a person—

(a)

who is a registered nurse or a registered midwife; and

(b)

against whose name is recorded in the professional register an annotation signifying that the person is qualified to order drugs, medicines and appliances from the Nurse Prescribers' Formulary for Community Practitioners in the current edition of the British National Formulary;

“contravention” includes failure to comply (and “contravene” has a corresponding meaning);

[F50“coronavirus” and “coronavirus disease” have the meanings given in section 1(1) of the Coronavirus Act 2020;]

“cosmetic” means any substance or preparation intended to be applied to the surfaces of the human body (including the epidermis, pilary system and hair, nails, lips and external genital organs), or the teeth or buccal mucosa, wholly or mainly for the purpose of—

(a)

perfuming them;

(b)

cleansing them;

(c)

protecting them;

(d)

caring for them or keeping them in condition;

(e)

modifying their appearance (for aesthetic purposes or otherwise); or

(f)

combating body odours or normal body perspiration;

[F40“country” means a country or territory;]

“dentist” means a person registered in the dentists register under section 14 of the Dentists Act 1984 M13;

[F40“Directive 2001/18/EC” means Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC – Commission Declaration;]

F51...

F52...

“disease” includes any injury, ailment or adverse condition, whether of body or mind;

[F53“dispensing content for patients”, in relation to an internet service, means content communicated publicly by an internet service provider as part of an internet service (for example, on a website) which is relevant to the dispensing of orders for the supply of medicinal products;]

“doctor” means a registered medical practitioner;

[F54“EAMS medicinal product” means a medicinal product that—

(a)

has been included in the Early Access to Medicines Scheme by means of the licensing authority issuing an EAMS scientific opinion in respect of it; and

(b)

remains in the scheme by virtue of the EAMS scientific opinion not ceasing to have effect in respect of it by virtue of regulation 167D;]

[F54“EAMS scientific opinion” is to be construed in accordance with regulation 167C(2)(b);]

[F54“EAMS scientific opinion holder” means the holder of a EAMS scientific opinion, and accordingly, is the person who places on the market the product to which the opinion relates;]

[F54“Early Access to Medicines Scheme” means the scheme of that name established and operated under regulation 167C(1);]

“effervescent”, in relation to a tablet or capsule, means containing not less than 75 per cent, by weight of the tablet or capsule, of ingredients included wholly or mainly for the purpose of releasing carbon dioxide when the tablet or capsule is dissolved or dispersed in water;

“electronic communication” means a communication transmitted (whether from one person to another, from one device to another or from a person to a device or vice versa)—

(a)

by means of an electronic communications network within the meaning of section 32(1) of the Communications Act 2003 M14; or

(b)

by other means but while in an electronic form;

[F55“electronic signature” has the meaning given within Article 3(10) of Regulation (EU) 910/2014 of the European Parliament and of the Council on electronic identification and trust services for electronic transactions in the internal market;]

“the EMA” means the European Medicines Agency established by Regulation (EC) No 726/2004;

“enactment” includes primary and secondary legislation of the devolved administrations in Wales, Scotland and Northern Ireland;

“enforcement authority” means the Secretary of State, the Minister for Health, Social Services and Public Safety or a person on whom a function of enforcing a provision of these Regulations has been conferred by virtue of regulations 323 or 324;

[F40“EU agreed paediatric investigation plan” means a paediatric investigation plan agreed in accordance with the Paediatric Regulation;

[F54“EU Clinical Trials Regulation” means Regulation EU No. 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products, and repealing Directive 2001/20/EC;]

“EU Exit Regulations” means the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019; ]

“EU marketing authorisation” means a marketing authorisation granted or renewed by the European Commission under Regulation (EC) No 726/2004;

“European Economic Area” or “EEA” means the European Economic Area created by the EEA agreement;

“the European Pharmacopoeia” means the European Pharmacopoeia published by the European Directorate for the Quality of Medicines;

[F56“excipient” means any constituent of a medicinal product other than the active substance and the packaging material;]

“exempt advanced therapy medicinal product” has the meaning given in regulation 171;

“expert advisory group” has the meaning given by regulation 14(1);

[F57“export” means export, or attempt to export, from the United Kingdom, whether by land, sea or air;]

[F58“external use” in relation to a medicinal product—

(a)

means its use by application to the skin, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal in circumstances where local action only is necessary and systemic absorption is unlikely to occur; but

(b)

does not include its use by means of a throat spray, nasal spray, nasal inhalation or teething preparation or by means of throat pastilles, throat lozenges, throat tablets or nasal drops;]

[F59“falsified medicinal product” means any medicinal product with a false representation of—

(a)

its identity, including its packaging and labelling, its name or its composition (other than any unintentional quality defect) as regards any of its ingredients including excipients and the strength of those ingredients;

(b)

its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or

(c)

its history, including the records and documents relating to the distribution channels used;

“Fees Regulations” means [F60the Medicines (Products for Human Use) (Fees) Regulations 2016];]

[F53“general practitioner” means a medical practitioner who is included in the General Practitioner Register kept under section 34C of the Medical Act 1983;]

“the Good Manufacturing Practice Directive” means [F61—

(a)

in the case of a medicinal product manufactured or assembled in, or imported into, Great Britain—

(i)

Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use, as modified by Schedule 2A, or

(ii)

if Regulations have been made under the powers in regulation B17(1), and have come into force, those Regulations;

(b)

in the case of a medicinal product manufactured or assembled in, or imported into, Northern Ireland, Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use;]

“the Health and Care Professions Council register” means the register established and maintained by the Health and Care Professions Council under article 5 of the [F62Health Professions Order 2001] M15;

“health care professional” means—

(a)

a doctor;

(b)

a dentist;

(c)

a pharmacist;

(d)

a pharmacy technician registered in Part 2 F63... of the Register of pharmacists and pharmacy technicians established and maintained under article 19(2) of the Pharmacy Order 2010 M16;

(e)

a registered nurse;

(f)

a registered midwife;

(g)

a registered optometrist;

(h)

a registered osteopath as defined in section 41 of the Osteopaths Act 1993 M17;

(i)

a registered chiropractor as defined in section 43 of the Chiropractors Act 1994 M18;

(j)

a person registered as a member of a relevant profession within the meaning of article 2 and paragraph 1 of Schedule 3 to the [F64Health Professions Order 2001], in the Health and Care Professions Council register; F65...

(k)

a person registered in the dental care professionals register established and maintained under section 36B of the Dentists Act 1984 M19 as a member of a profession complementary to dentistry specified by regulation 2 of the General Dental Council (Professions Complementary to Dentistry) Regulations 2006 M20; [F66or

(l)

a person registered under the Anaesthesia Associates and Physician Associates Order 2024]

“health centre” means a health centre maintained under—

(a)

section 2 or 3 of the National Health Service Act 2006 M21;

(b)

section 2 or 3 of the National Health Service (Wales) Act 2006 M22;

(c)

section 36(1)(b) of the National Health Service (Scotland) Act 1978 M23; or

(d)

article 5 of the Health and Personal Social Services (Northern Ireland) Order 1972 M24;

F67...

“herbal medicinal product” means a medicinal product whose only active ingredients are herbal substances or herbal preparations (or both);

“herbal preparation” means a preparation obtained by subjecting herbal substances to processes such as extraction, distillation, expression, fractionation, purification, concentration or fermentation, and includes a comminuted or powdered herbal substance, a tincture, an extract, an essential oil, an expressed juice or a processed exudate;

“herbal substance” means a plant or part of a plant, algae, fungi or lichen, or an unprocessed exudate of a plant, defined by the plant part used and the botanical name of the plant, either fresh or dried, but otherwise unprocessed;

“homoeopathic medicinal product” means a medicinal product prepared from homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by—

(a)

the European Pharmacopoeia; or

(b)

in the absence of such a description in the European Pharmacopoeia,

(i)

[F68 in relation to a certificate of registration or marketing authorisation for a national homoeopathic product in force in Great Britain only, the British Pharmacopoeia, or in an pharmacopoeia used officially in an country that is included in a list published by the licensing authority for this purpose;

(ii)

in relation to a certificate of registration or marketing authorisation for a national homoeopathic product in force in the whole United Kingdom or in Northern Ireland only, in the British Pharmacopoeia or in any pharmacopoeia used officially in an EEA State;]

[F69“hospice” means an institution whose primary function is the provision of palliative care to persons resident there who are suffering from a progressive disease in its final stages;]

“hospital” includes a clinic, nursing home or similar institution;

“immediate packaging” in relation to a medicinal product means the container or other form of packaging immediately in contact with the medicinal product;

[F70“import” means import, or attempt to import, into the United Kingdom, whether by land, sea or air [F71and “imported” is to be construed accordingly];]

“inspector” means a person authorised in writing by an enforcement authority for the purposes of Part 16 (enforcement) (and references to “the enforcement authority”, in relation to an inspector, are to the enforcement authority by whom the inspector is so authorised);

“intermediate product” means a substance which—

(a)

has been manufactured for use in the manufacture of medicinal products; and

(b)

is intended for further processing by a manufacturer of such products;

[F53“internet service” means a service made publicly available by means of the internet, which includes a service made publicly available by means of a combination of the internet and an electronic communications service or electronic communications network (within the meanings given to those expressions in section 32 of the Communications Act 2003);]

“investigational medicinal product” has the meaning given in regulation 2(1) of the Clinical Trials Regulations;

“labelling” in relation to a container or package of medicinal products means affixing to or otherwise displaying on it a notice describing or otherwise relating to the contents (and “label” has a corresponding meaning);

“the licensing authority” has the meaning given by regulation 6(2);

[F39“listed NIMAR product” means a product included in a list maintained in accordance with regulation 167B on the date it is dispatched from Great Britain to Northern Ireland;]

[F72“local naloxone provider” is to be construed in accordance with regulation 237A(3);]

“manufacture”, in relation to a medicinal product, includes any process carried out in the course of making the product, but does not include dissolving or dispersing the product in, or diluting or mixing it with, a substance used as a vehicle for the purpose of administering it;

“manufacturer's licence” has the meaning given by regulation 17(1);

[F73“manufacturer’s licence (MM)” means a manufacturer’s licence that relates to the manufacture or assembly of MM medicinal products specified in that licence;]

[F73“manufacturer’s licence (POC)” means a manufacturer’s licence that relates to the manufacture or assembly of POC medicinal products specified in that licence;]

“marketing authorisation” means—

(a)

a UK marketing authorisation; F74...

(b)

F74...

“medicinal product subject to general sale” has the meaning given in regulation 5(1) (classification of medicinal products);

[F40“medical device”—

(a)

has the meaning given in regulation 2 of the Medical Devices Regulations 2002; or

(b)

to the extent necessary for the practical application of that definition, also or instead has the meaning given in regulation 69 of those Regulations;]

[F53“medicinal products on a general sale list” means medicinal products subject to general sale, as provided for by regulation 5(1)(a) (and related expressions are to be construed accordingly);]

“the Ministers” is to be construed in accordance with regulation 6(6) to (8);

[F73“MM” means modular manufacture;]

[F73“MM control site” means the premises at which the holder of a manufacturer’s licence (MM) supervises and controls the manufacture or assembly of MM medicinal products;]

[F73“MM master file” means a detailed description of the arrangements for the manufacture or assembly of an MM medicinal product;]

[F73“MM medicinal product” means a medicinal product that, for reasons relating to deployment, the licensing authority determines it necessary or expedient to be manufactured or assembled in a modular unit;]

[F73“modular unit” means a relocatable manufacturing unit;]

[F72“naloxone product” means a medicinal product that contains naloxone or a salt, ester or stereoisomeric form of naloxone;]

“name” in relation to a medicinal product means—

(a)

where the product has a UK marketing authorisation or traditional herbal registration, the name—

(i)

as approved by the licensing authority in granting the authorisation or registration, or

(ii)

where that name has been varied since that approval, as so amended;

(b)

F75... and

(c)

where the product has an Article 126a authorisation, the name—

(i)

as approved by the licensing authority to appear on the packaging and any package leaflet of the product under the authorisation, or

(ii)

where that name has been varied since that approval, as so amended;

“the Narcotic Drugs Convention” means the Single Convention on Narcotic Drugs signed by the United Kingdom on 30thMarch 1961 as amended by the Protocol Amending the Single Convention on Narcotic Drugs signed by the United Kingdom on 25th March 1972;

[F53“NHS dispensing practice” means the business as part of which NHS pharmaceutical services are provided by general practitioners;]

[F53“NHS pharmaceutical services” means—

(a)

in England, pharmaceutical services under Part 7 of the National Health Service Act 2006;

(b)

in Wales, pharmaceutical services under Part 7 of the National Health Service (Wales) Act 2006;

(c)

in Scotland, pharmaceutical services under Part 2 of the National Health Service (Scotland) Act 1978;

(d)

in Northern Ireland, pharmaceutical services under Part 6 of the Health and Personal Social Services (Northern Ireland) Order 1972;]

“NHS primary dental services” means—

(a)

in relation to England, primary dental services under the National Health Service Act 2006;

(b)

in relation to Wales, primary dental services under the National Health Service (Wales) Act 2006;

(c)

in relation to Scotland, dental services under the National Health Service (Scotland) Act 1978 or personal dental services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1997 M25; and

(d)

in relation to Northern Ireland, general dental services under the Health and Personal Social Services (Northern Ireland) Order 1972 or personal dental services in connection with a pilot scheme under the Health Services (Primary Care) (Northern Ireland) Order 1997 M26;

“NHS primary medical services” means—

(a)

in relation to England, primary medical services under the National Health Service Act 2006;

(b)

in relation to Wales, primary medical services under the National Health Service (Wales) Act 2006;

(c)

in relation to Scotland, primary medical services under the National Health Service (Scotland) Act 1978; and

(d)

in relation to Northern Ireland, primary medical services under the Health and Personal Social Services (Northern Ireland) Order 1972;

[F39“NIMAR” means Northern Ireland MHRA authorised route;]

“nurse independent prescriber” means a person who—

(a)

is a registered nurse or registered midwife; and

(b)

is noted in the professional register as qualified to order drugs, medicines and appliances as a nurse independent prescriber or a nurse independent / supplementary prescriber;

[F40“nursing home” has the meaning given by article 11 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003; ]

[F76“occupational health vaccinator” means a person who is employed or engaged by a person operating an occupational health scheme, who is an individual belonging to one of the classes of individuals specified in Part 4 of Schedule 16;]

“optometrist independent prescriber” means a person—

(a)

who is a registered optometrist; and

(b)

against whose name is recorded in the relevant register an annotation signifying that the person is qualified to order drugs, medicines and appliances as an optometrist independent prescriber;

[F40“orphan criteria” means the criteria listed in regulation 50G(2);]

[F40“orphan marketing authorisation” means a UK marketing authorisation granted under regulation 49(1)(a) in accordance with regulation 58C;]

[F40“Orphan Regulation” means Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products as it has effect in EU law;]

“outer packaging” in relation to a medicinal product means any packaging into which the immediate packaging of the medicinal product is placed;

“package” in relation to a medicinal product, includes—

(a)

a container of the product;

(b)

any box, packet or other article in which one or more containers of the product are or are to be enclosed; and

(c)

any box, packet or other article in which a box, packet or other article mentioned in paragraph (b) or this paragraph is or is to be enclosed;

“package leaflet” in relation to a medicinal product, means a leaflet that accompanies the product and contains information for the user of the product;

“paediatric clinical trial” means a clinical trial conducted in whole or in part on persons under the age of 18 years;

[F40“paediatric indication” means a term of a UK marketing authorisation enabling the medicinal product to which the authorisation relates to be used by or administered to persons under the age of 18 years;]

“paediatric investigation plan” means a research and development programme with the purpose of generating data determining the conditions in which a medicinal product may be authorised to treat persons under the age of 18 years;

[F40“paediatric population” means that part of the population consisting of persons under the age of 18 years;]

“the Paediatric Regulation” means Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 M27;

[F40“parallel import licence” has the meaning given in regulation 48(2);]

[F77“paramedic independent prescriber” means a person—

(a)

who is a registered paramedic; and

(b)

against whose name is recorded in the relevant register an annotation signifying that the person is qualified to order drugs, medicines and appliances as a paramedic independent prescriber;]

“periodic safety update report” or “PSUR” has the meaning given in regulation 191 (obligation on holder to submit periodic safety update reports: general requirements);

“pharmacist” means—

(a)

in relation to Great Britain a person registered in Part 1 F78... of the Register of pharmacists and pharmacy technicians maintained under article 19(2) of the Pharmacy Order 2010 M28; and

(b)

in relation to Northern Ireland a person registered in the register of pharmaceutical chemists for Northern Ireland F79... maintained under articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 M29;

“pharmacist independent prescriber” means a person who—

(a)

is a pharmacist; and

(b)

is noted in the relevant register as qualified to order drugs, medicines and appliances as a pharmacist independent prescriber;

“the Pharmacovigilance Risk Assessment Committee” means the committee of the EMA established by Article 56(1)(aa) of Regulation (EC) No 726/2004;

“pharmacovigilance system” means a system used by the holder of a [F80UK marketing authorisation F81...], traditional herbal registration or Article 126a authorisation, or by the licensing authority, to fulfil the tasks and responsibilities set out in Part 11 and designed to monitor the safety of authorised or registered medicinal products and detect any change to their risk-benefit balance;

“pharmacovigilance system master file” means a detailed description of the pharmacovigilance system used by the holder of a [F80UK marketing authorisation F82...], traditional herbal registration or Article 126a authorisation with respect to one or more authorised or registered medicinal products;

“pharmacy medicine” has the meaning given in regulation 5(5) (classification of medicinal products);

[F83“physiotherapist independent prescriber” means a person—

(a)

who is a registered physiotherapist; and

(b)

against whose name is recorded in the relevant register an annotation signifying that the person is qualified to order drugs, medicines and appliances as a physiotherapist independent prescriber;

[F73“POC” means point of care;]

[F73“POC control site” means the premises at which the holder of a manufacturer’s licence (POC) supervises and controls the manufacture or assembly of POC medicinal products;]

[F73“POC master file” means a detailed description of the arrangements for the manufacture or assembly of a POC medicinal product;]

[F73“POC medicinal product” means a medicinal product that, for reasons relating to method of manufacture, shelf life, constituents or method or route of administration, can only be manufactured at or near the place where the product is to be used or administered;]

[F73“POC site” means a site at which the manufacture or assembly of a POC medicinal product takes place;]

“podiatrist independent prescriber” means a person—

(a)

who is a registered podiatrist; and

(b)

against whose name is recorded in the relevant register an annotation signifying that the person is qualified to order drugs, medicines and appliances as a podiatrist independent prescriber;]

“post-authorisation efficacy study” means any study relating to a medicinal product to which a [F84UK] marketing authorisation relates that is conducted with the aim of considering the efficacy of that product;

“post-authorisation safety study” means any study relating to a medicinal product to which a [F80UK marketing authorisation F85...], traditional herbal registration or Article 126a authorisation relates that is conducted with the aim of—

(a)

identifying, characterising or quantifying a safety hazard;

(b)

confirming the safety profile of the medicinal product; or

(c)

measuring the effectiveness of risk management measures;

“prescription only medicine” has the meaning given in regulation 5(3) (classification of medicinal products);

“product information” in relation to a medicinal product means—

(a)

the summary of the product characteristics;

(b)

the immediate and outer packaging; and

(c)

the package leaflet;

“the professional register” means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 2001 M30;

[F72“provider of probation services”—

(a)

in England and Wales, has the same meaning as in Part 1 of the Offender Management Act 2007 (new arrangements for the provision of probation services); and

(b)

in Northern Ireland, means the Probation Board for Northern Ireland;

“provider of youth justice services” means—

(a)

in England and Wales, a provider, other than a local authority, of the services specified in section 38(4) of the Crime and Disorder Act 1998 (local provision of youth justice services);

(b)

in Scotland, a provider, other than a local authority, of the services in Scotland in respect of a child that most closely correspond to the services specified in section 38(4) of the Crime and Disorder Act 1998, and for these purposes “child” has the meaning given in section 199 of the Children’s Hearings (Scotland) Act 2011 (meaning of “child”); and

(c)

in Northern Ireland, a body or other person with which or whom the Department of Justice has made arrangements for the provision of juvenile justice centres pursuant to Article 51(2) of the Criminal Justice (Children) (Northern Ireland) Order 1998 (juvenile justice centres);]

“the Psychotropic Substances Convention” means the Convention on Psychotropic Substances signed by the United Kingdom on 21st February 1971;

“qualified person”, except in relation to the expression “appropriately qualified person”, means—

(a)

a person who satisfies the requirements specified in Part 1 or 2 of Schedule 7; or

(b)

where an application for a licence is made before 30th April 2013, in so far as the application relates to activities in respect of traditional herbal medicinal products, a person who has been engaged in activities in respect of traditional herbal medicinal products equivalent to those in Part 3 of Schedule 7 on or before 30th April 2011 and continues to be so engaged at the time when the application is made;

[F40“qualifying Northern Ireland goods” has the same meaning that it has in the European Union (Withdrawal) Act 2018, including any meaning defined for the purposes of that Act from time to time by regulations made under the power conferred by section 8C(6) of that Act;]

[F86“radiation emergency” has the meaning given by regulation 2(1) of the [F87Radiation (Emergency Preparedness and Public Information) Regulations 2019];]

“radionuclide” means a radioactive isotope;

“radionuclide generator” means any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be removed by elution or by any other method and is to be used in a radiopharmaceutical;

“radionuclide kit” means any preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration;

“radionuclide precursor” means any radionuclide produced for the radio-labelling of another substance prior to administration, other than a radionuclide that is incorporated in or produced from a generator or is included in a radiopharmaceutical;

“radiopharmaceutical” means a medicinal product which, when ready for use, contains one or more radionuclides included for a medicinal purpose;

[F88“registered dietitian” means a person registered in Part 4 of the Health and Care Professions Council register;]

“registered midwife” means a person registered in the Midwives Part of the professional register;

“registered nurse” means a person registered in the Nurses Part or the Specialist Community Public Health Nurses Part of the professional register;

“registered optometrist” means a person whose name is entered in the register of optometrists maintained under section 7(a) of the Opticians Act 1989 M31 F89...;

[F90“registered paramedic” means a person who is registered in Part 8 of the Health and Care Professions Council register;]

“registered pharmacy” means—

(a)

in relation to Great Britain, premises entered in the register required to be kept under article 19 of the Pharmacy Order 2010 for the purposes of sections 74A and 74J of the Medicines Act 1968 M32; and

(b)

in relation to Northern Ireland, premises entered in the register required to be kept under section 75 M33 of the Medicines Act 1968;

[F91“registered physiotherapist” means a person registered in Part 9 of the Health and Care Professions Council register;

“registered podiatrist” means a person registered in Part 2 of the Health and Care Professions Council register;

“registered radiographer” means a person registered in Part 11 of the Health and Care Professions Council register;]

“registrable homoeopathic medicinal product” means a homoeopathic medicinal product to which regulation 102 applies;

[F92“Regulation (EC) No 726/2004” means Regulation (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency [F93, as it has effect in EU law];]

F94...

“Regulation (EC) No 1234/2008” means Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products M34 [F95, as it has effect in EU law];

“the relevant EU provisions” means the provisions of legislation of the European Union relating to medicinal products for human use, except to the extent that any other enactment provides for any function in relation to any such provision to be exercised otherwise than by the licensing authority;

“relevant European State” means an EEA State or Switzerland;

“relevant medicinal product” has the meaning given by regulation 48;

“the relevant register” means—

(a)

in relation to a pharmacist—

(i)

in Great Britain, Part 1 of the Register of pharmacists and pharmacy technicians maintained under article 19(2) of the Pharmacy Order 2010, or

(ii)

in Northern Ireland, the register maintained in pursuance of articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976;

(b)

in relation to a registered nurse or registered midwife, the professional register;

(c)

in relation to a registered optometrist, the register of optometrists maintained under section 7(a) of the Opticians Act 1989 F96...; and

(d)

in relation to a chiropodist or podiatrist, a physiotherapist[F97, an orthoptist] [F98, a paramedic] or a radiographer, the part of the Health and Care Professions Council register relating to—

(i)

chiropodists and podiatrists,

(ii)

physiotherapists, F99...

(iii)

radiographers[F100, F101...

(iv)

orthoptists] [F102, or

(v)

paramedics;]

“retail pharmacy business” means a business (other than a professional practice carried on by a doctor [F103, any other professional practice which is an NHS dispensing practice or a professional practice carried on by a dentist)] which consists of or includes the retail sale of medicinal products that are not subject to general sale;

“risk management plan” means a detailed description of the risk management system;

“risk management system” means a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including an assessment of the effectiveness of those activities and interventions;

“serious adverse reaction” means an adverse reaction that—

(a)

results in a person's death;

(b)

threatens a person's life;

(c)

results in a person being hospitalised as an inpatient or prolongs a person's existing stay in hospital;

(d)

results in a person's persistent or significant disability or incapacity; or

(e)

results in a congenital anomaly or birth defect;

“special medicinal product” means a product within the meaning of regulation 167 or any equivalent legislation in [F104a country] other than the United Kingdom;

“substance” means any matter regardless of its origins and includes—

(a)

human substances (such as human blood and human blood products);

(b)

animal substances (such as micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts and blood products);

(c)

vegetable substances (such as micro-organisms, plants, parts of plants, vegetable secretions and extracts);

(d)

chemical substances (such as elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis); and

(e)

gases and vapours;

“the summary of the product characteristics” in relation to a medicinal product means—

(a)

where the product has a UK marketing authorisation or traditional herbal registration, the summary of the product characteristics—

(i)

as approved by the licensing authority in granting the authorisation or registration, or

(ii)

where the summary has been varied since that approval, as so amended; or

(b)

where the product has an EU marketing authorisation, the summary of the product characteristics—

(i)

as approved by the European Commission in granting the authorisation, or

(ii)

where the summary has been varied since that approval, as so amended;

“supplementary prescriber” means a person who is noted in the relevant register as qualified to order drugs, medicines and appliances as a supplementary prescriber (or, in the case of a registered nurse or registered midwife, as a nurse independent/supplementary prescriber) and is—

(a)

a pharmacist;

(b)

a registered midwife;

(c)

a registered nurse;

(d)

a chiropodist, podiatrist, physiotherapist[F105, paramedic] or radiographer; F106...

(e)

a registered optometrist; [F107or

(f)

a registered dietitian;]

[F40“supplementary protection certificate” has the meaning given in section 128B(2) of the Patents Act 1977;]

“suspected” in relation to an adverse reaction means that there is at least a reasonable possibility of there being a causal relationship between a medicinal product and an adverse event;

[F108“therapeutic radiographer independent prescriber” means a person—

(a)

who is a registered radiographer; and

(b)

against whose name is recorded in the relevant register—

(i)

an entitlement to use the title “therapeutic radiographer”; and

(ii)

an annotation signifying that the person is qualified to order drugs, medicines and appliances as a therapeutic radiographer independent prescriber;]

F109...

“traditional herbal medicinal product” means a herbal medicinal product to which regulation 125 applies;

“traditional herbal registration” means a traditional herbal registration granted by the licensing authority under these Regulations [F110and—

(a)

“THR(UK)” means such a registration in force in the whole United Kingdom;

(b)

“THR(GB)” means such a registration in force in Great Britain only;

(c)

“THR(NI)” means such a registration in force in Northern Ireland only;]

[F111“UK marketing authorisation” means a marketing authorisation granted by the licensing authority under Part 5 of these Regulations or Chapter 4 of Title III to the 2001 Directive (mutual recognition and decentralised procedure) and—

(a)

“UKMA(UK)” means such an authorisation [F112, within the definition of UKMA(UK)(Category 1) or UKMA(UK)(Category 2),] in force in the whole United Kingdom;

(b)

“UKMA(GB)” means such an authorisation in force in Great Britain only;

(c)

“UKMA(NI)” means such an authorisation in force in Northern Ireland only.]

[F113“UKMA(UK)(Category 1)” means a marketing authorisation of the description in regulation 49(1ZB);

“UKMA(UK)(Category 2)” means a marketing authorisation of the description in regulation 49(1ZC);]

[F40“under the unfettered access route” means an application for—

(a)

a [F114UKMA(UK)(Category 2)] under reduced or alternative requirements specified in Part 5 (as referred to in regulation 49(1A));

(b)

a COR(GB) under reduced or alternative requirements specified in Part 6 (as referred to in regulation 103(1A));

(c)

a THR(GB) under reduced or alternative requirements specified in Part 7 (as referred to in regulation 127(1A));]

“vaccine” means an antigenic substance which consists wholly or partly of—

(a)

any micro-organisms, viruses or other organisms in any state;

(b)

any toxins of microbial origin which have been detoxified (toxoids); or

(c)

any extracts or derivatives of any micro-organisms or of any viruses,

being substances which, when administered to human beings, are used for the prevention of specific diseases;

[F40“variation to the terms of a UK marketing authorisation” means any change to—

(a)

the information provided in accordance with regulations 50 to 57 and Schedule 8; or

(b)

the terms of the decision granting the UK marketing authorisation, including the summary of the product characteristics and any conditions, obligations, or restrictions affecting that UK marketing authorisation, or changes to the labelling or the package leaflet connected with changes to the summary of the product characteristics,

and “vary” and “variation” in relation to a UK marketing authorisation are to be construed accordingly;.]

[F40“withdrawal agreement” has the meaning given in section 39 of the European Union (Withdrawal Agreement) Act 2020;]

“wholesale dealer's licence” has the meaning given by regulation 18(1).

(2) In these Regulations, references to distribution of a product by way of wholesale dealing are to be construed in accordance with regulation [F11518(4) and (5)].

[F116(3) In these Regulations, references to selling by retail, or to retail sale, are references to—

(a)selling a product to a person who buys it otherwise than for a purpose specified in regulation 18(5); or

(b)selling or supplying that is treated as or as part of a retail sale by virtue of regulation 222A(2)(a).]

(4) In these Regulations, references to supplying anything in circumstances corresponding to retail sale are references to supplying it, otherwise than by way of sale, to a person who receives it otherwise than for a purpose specified in regulation [F11718(5)];

(5) References in these Regulations to the terms of—

(a)a [F118UK] marketing authorisation include the information supplied in relation to the authorisation in accordance with—

(i)regulation 50 and Schedule 8, and

(ii)(if appropriate) Schedule 10 (national homoeopathic products),

as updated in accordance with regulation 57, as approved upon grant under regulation 49 and as varied under regulation 68;

(b)a certificate of registration include the information supplied in relation to the certificate in accordance with regulation 103, as approved upon grant under regulation 103 and as varied under regulation 110; and

(c)a traditional herbal registration include the information supplied in relation to the registration in accordance with regulation 128 and Schedule 12, as updated in accordance with regulation 129, as approved upon grant under regulation 127 and as varied under regulation 135.

(6) References in these Regulations to a condition of—

(a)a [F119UK] marketing authorisation is to a condition to which the authorisation is subject by virtue of regulation 59(1) [F120, 60(1) or 60A]; and

(b)a certificate of registration is to a condition to which the certificate is subject by virtue of regulation 105(1).

(7) For the purposes of these Regulations medicinal products are of the same description if—

(a)they are manufactured to the same specification, and

(b)they are in the same pharmaceutical form.

[F121(8) [F122Subject to regulation C17(6), references] in these Regulations to—

(a)good manufacturing practice for active substances relate to the principles and guidelines for good manufacturing practice adopted by the European Commission under the third paragraph of Article 47 of the 2001 Directive;

(b)good distribution practice for active substances relate to the guidelines on good distribution practices for active substances adopted by the European Commission under the fourth paragraph of Article 47 of the 2001 Directive.]

[F123(9) Unless otherwise provided, any provision of an EU Regulation made applicable to a UKMA(NI), COR(NI) or THR(NI) by virtue of Article 5(4) of, and Annex 2 to, the Protocol on Ireland/Northern Ireland in the EU withdrawal agreement applies equally in respect of a [F124UKMA(UK)(Category 2)], COR(UK) or THR(UK).]

Textual Amendments

F58Words in reg. 8(1) inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 3(2)(a) and words in reg. 8(1) inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 3(2)(a)

F69Words in reg. 8(1) inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 3 and words in reg. 8(1) inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 3

F88Words in reg. 8(1) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 3(2)(b) and words in reg. 8(1) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 3(2)(b)

F91Words in reg. 8(1) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 3(2)(c) and words in reg. 8(1) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 3(2)(c)

F99Word in reg. 8(1) omitted (1.10.2017) by virtue of The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 3(2)(b)(ii) and word in reg. 8(1) omitted (N.I.) (1.10.2017) by virtue of The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 3(2)(b)(ii)

F101Word in reg. 8(1) omitted (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 3(2)(d)(ii) and word in reg. 8(1) omitted (N.I.) (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 3(2)(d)(ii)

F106Word in reg. 8(1) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 3(2)(d)(i) and word in reg. 8(1) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 3(2)(d)(i)

F107Words in reg. 8(1) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 3(2)(d)(ii) and words in reg. 8(1) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 3(2)(d)(ii)

F108Words in reg. 8(1) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 3(2)(a) and words in reg. 8(1) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 3(2)(a)

F115Words in reg. 8(2) substituted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 3(2) and words in reg. 8(2) substituted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 3(2)

F117Word in reg. 8(4) substituted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 3(4) and word in reg. 8(4) substituted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 3(4)

Modifications etc. (not altering text)

C3Reg. 8(1) applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

Marginal Citations

M11OJ No L 121, 1.5.2001, p.34. Directive 2001/20/EC was last amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p.14).

M12S.I. 2004/1031, to which there are amendments not relevant to these Regulations.

M131984 c.24. Section 14 was substituted by the Dentists Act 1984 (Amendment) Order 2005 (S.I. 2005/2011) articles 2 and 6 and further amended by the European Qualifications (Health and Social Care Professions) Regulations 2007 (S.I. 2007/3101), regulations 109 and 111. Other amendments of the Dentists Act are not relevant to these Regulations.

M15S.I. 2002/254, as amended by S.I. 2009/1182. There are other amendments that are not relevant.

M171993 c.21. Section 41 was amended by S.I. 2007/3101 regulations 206 and 214.

M191984 c.24. Section 36B was inserted by S.I. 2005/2011, articles 2(1) and 29.

M231978 c.29. Concurrent functions under section 36(1) were transferred to the National Waiting Times Board by article 4(2)(c) and (4) of S.S.I. 2002/305.

M27OJ No L 378, 27.12.2006, p.1. Regulation (EC) No 1901/2006, as amended by Regulation (EC) No 1902/2006 (OJ No L 378, 27.12.2006, p.20) .

M311989 c.44; section 7(a) was amended by S.I. 2005/848, articles 2 and 7(1).

M321968 c.67. Sections 74A and 74J were inserted by article 68 of and paragraph 1 of Schedule 4 to S.I. 2010/231.

M33Section 75 was amended by article 68 of and paragraph 1 of Schedule 4 to S.I. 2010/231

M34OJ No L 334, 12.12.2008, p.7.

PART 2U.K.Administration

Commission on Human MedicinesU.K.

9.—(1) There is to continue to be a body known as the Commission on Human Medicines (referred to in these Regulations as “the Commission”).

(2) The Commission is to perform the functions conferred on it by these Regulations.

(3) The Commission is to have at least eight members.

(4) The members of the Commission are to be appointed by the Ministers.

(5) The Ministers must appoint one of the members of the Commission to chair it.

(6) The Ministers must consult the Scottish Ministers before exercising their functions under paragraphs (4) and (5).

Functions of the CommissionU.K.

10.—(1) The Commission must give advice to either or both of the Ministers in relation to the matters listed in paragraph (2) if—

(a)the Minister, or Ministers, request it; or

(b)the Commission considers it appropriate to give it.

(2) The matters mentioned in paragraph (1) are matters—

(a)relating to the execution of any duty imposed by these Regulations or the Clinical Trials Regulations;

(b)relating to the exercise of any power conferred by these Regulations or the Clinical Trials Regulations; or

(c)otherwise relating to medicinal products.

(3) Without prejudice to paragraphs (1) and (2), or to any other functions conferred on the Commission by or under these Regulations, the Commission must—

(a)give advice with respect to the safety, quality and efficacy of medicinal products; and

(b)promote the collection and investigation of information relating to adverse reactions, for the purposes of enabling such advice to be given.

(4) The Commission must also advise the licensing authority if—

(a)the licensing authority is required under Schedule 11 (advice and representations) or the Clinical Trials Regulations to consult the Commission about any matter arising under those provisions; or

(b)the licensing authority consults the Commission about any matter arising under those provisions.

British Pharmacopoeia CommissionU.K.

11.—(1) There is to continue to be a committee called the British Pharmacopoeia Commission (referred to as “the BPC” in this regulation).

(2) The BPC is to continue to have the following functions—

(a)the preparation under regulation 317(1) of editions of the British Pharmacopoeia;

(b)the preparation of compendia under regulation 317(3);

(c)the preparation under regulation 318 (which provides for the preparation and publication of lists of names to be used as headings to monographs in the British Pharmacopoeia) of lists of names; and

(d)the preparation of any other document under regulation 319.

(3) The BPC is to have at least eight members.

(4) The members of the BPC are to be appointed by the Ministers.

(5) The Ministers must appoint one of the members of the BPC to chair it.

(6) The Ministers must consult the Scottish Ministers before exercising their functions under paragraphs (4) and (5).

(7) In this regulation, a reference to preparation includes revision or amendment.

Reporting to MinistersU.K.

12.—(1) In this Part “advisory body” means—

(a)the Commission, or

(b)the British Pharmacopoeia Commission.

(2) Each advisory body must give a report to the Ministers each year about—

(a)the performance of its functions; and

(b)the performance of the functions of any expert advisory group appointed by it under regulation 14 (including any expert advisory group appointed jointly with the other advisory body).

(3) Each advisory body must give its report to the Ministers at the time specified by the Ministers.

(4) The Secretary of State must lay a copy of each report before Parliament.

Co-option of additional members of advisory bodiesU.K.

13.—(1) An advisory body may co-opt one or more additional members for the purposes of a meeting.

(2) A person co-opted as a member of an advisory body for the purposes of a meeting ceases to be a member at the end of the meeting.

Appointment of expert advisory groupsU.K.

14.—(1) An advisory body, or the advisory bodies acting jointly, may with the approval of the licensing authority appoint one or more sub-committees, to be known as expert advisory groups.

(2) The licensing authority may direct an advisory body to appoint an expert advisory group to advise on the matters specified in the direction.

(3) An expert advisory group may include, or consist of, persons who are not members of the advisory body or bodies which appointed the expert advisory group.

(4) The advisory body or bodies which appointed the expert advisory group must appoint a member of the group as its chair.

(5) The chair of an expert advisory group may co-opt additional members of the group for the purposes of a meeting.

(6) Before co-opting additional members under paragraph (5) the chair of the group must consult the chair of the advisory body or bodies which appointed the group.

(7) A person co-opted as a member of an expert advisory group for the purposes of a meeting ceases to be a member of the group at the end of the meeting.

Delegation of functions to expert advisory groupsU.K.

15.—(1) An advisory body may delegate any of its functions, other than the functions specified in paragraph (2), to an expert advisory group.

(2) The functions which may not be delegated are functions of providing advice to the licensing authority in any case where the licensing authority is required to consult the advisory body under—

(a)Schedule 11 (advice and representations); and

(b)the Clinical Trials Regulations.

(3) But an advisory body may arrange for an expert advisory group to provide advice to the advisory body in relation to the performance of a function referred to in paragraph (2).

Further provision about advisory bodies and expert advisory groups etcU.K.

16.  Schedule 2 (which makes further provision about advisory bodies and expert advisory groups, and provision about payment and expenses of expert committees appointed by the licensing authority) has effect.

PART 3U.K.[F125Manufacture and distribution of medicinal products and active substances

Textual Amendments

F125 Pt. 3 heading and Pt. 3 Ch. 1 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4

CHAPTER 1U.K.Interpretation

InterpretationU.K.

A17.  In this Part “manufacture”, in relation to an active substance, includes any process carried out in the course of making the substance and the various processes of dividing up, packaging, and presentation of the active substance.]

[F126Chapter 1AU.K.Good manufacturing practice and good distribution practice

Textual Amendments

Regulations on good manufacturing practiceU.K.

B17.—(1) The Secretary of State may by regulations in respect of Great Britain set out principles and guidelines of good manufacturing practice in respect of medicinal products and investigational medicinal products.

(2) Regulations under paragraph (1) may in particular make provisions as to—

(a)inspections;

(b)compliance with good manufacturing practice and, where relevant, the UK marketing authorisation F127...;

(c)quality assurance systems;

(d)personnel;

(e)premises and equipment;

(f)documentation;

(g)production;

(h)quality control;

(i)the contracting out of work;

(j)complaints and product recall;

(k)self-inspection.

(3) Subject to any provision made in regulations under paragraph (1), the principles and guidelines set out in the Good Manufacturing Practice Directive have effect in Great Britain on and after IP completion day as they had effect immediately before IP completion day, but subject to the modifications specified in Schedule 2A.

(4) The Secretary of State may by regulations in respect of Great Britain amend or revoke Schedule 2A.

Textual Amendments

Guidelines on good manufacturing practice and good distribution practiceU.K.

C17.—(1) The licensing authority may publish in relation to the manufacture or assembly of a medicinal product in, or import to, [F128the United Kingdom]—

(a)detailed guidelines of good manufacturing practice in respect of medicinal products, and investigational medicinal products, referred to in Article 46(f) of the 2001 Directive, including guidelines as to the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients;

(b)principles and guidelines of good manufacturing practice for active substances, referred to in the first paragraph of point (f) of Article 46 and in Article 46b of that Directive;

(c)principles and guidelines of good distribution practice referred to in the first paragraph of point (f) of Article 46, and Article 84, of that Directive.

(2) Guidelines or principles under paragraph (1) may replace, amend or otherwise modify any guidelines or principles published or adopted by the European Commission under the second, third, fourth or fifth paragraph of Article 47, or Article 84, of the 2001 Directive.

(3) Unless replaced by principles or guidelines published under paragraph (1), principles and guidelines published or adopted by the European Commission under the second, third, fourth or fifth paragraph of Article 47, or Article 84, of the 2001 Directive, as they applied immediately before IP completion day, continue to apply on and after IP completion day (subject to any amendments or modifications published under paragraph (1)).

(4) Before exercising the power under paragraph (1), the licensing authority must consult such persons as it considers appropriate.

(5) The licensing authority may only exercise its power under paragraph (1) if it considers that it is necessary in order to take account of technical or scientific progress.

(6) If the licensing authority publishes principles and guidelines under paragraph (1), any reference in these Regulations to any principle or guideline adopted under the provisions of the 2001 Directive specified in those paragraphs is instead to be read as a reference to the principle or guideline published under paragraph (1), or that principle or guideline as amended or modified (as the case may be).]

Textual Amendments

[F129CHAPTER 2]U.K.Manufacturing and wholesale dealing

Textual Amendments

Grant etc of licencesU.K.

Manufacturing of medicinal productsU.K.

17.—[F130(1) A person may not except in accordance with a licence [F131of the appropriate type] (a “manufacturer's licence”)—

(a)manufacture a medicinal product,

(b)assemble a medicinal product,

(c)import a medicinal product into Great Britain from a country other than—

(i)Northern Ireland, or

(ii)an approved country for import,

(d)import a medicinal product into Northern Ireland from a country other than an EEA State, or

(e)possess a medicinal product for the purpose of any activity in sub-paragraphs (a) to (d).]

[F132(1A) For the purposes of paragraph (1), the appropriate type of manufacturer’s licence is a licence that relates to whichever, or whichever combination, of the following that is appropriate—

(a)manufacture and assembly of medicinal products, except for advanced therapy medicinal products, MM medicinal products, POC medicinal products or special medicinal products;

(b)import of medicinal products, except for special medicinal products, MM medicinal products or POC medicinal products;

(c)manufacture and assembly of advanced therapy medicinal products;

(d)manufacture and assembly of MM medicinal products;

(e)manufacture and assembly of POC medicinal products;

(f)manufacture and assembly of special medicinal products;

(g)import of special medicinal products.]

(2) Paragraph (1) is subject to [F133paragraphs (3) to (9)].

(3) Paragraph (1) applies in relation to an investigational medicinal product only—

(a)if the product has a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration; and

(b)to the extent that the manufacture or assembly of the product is in accordance with the terms and conditions of that authorisation, certificate or registration.

(4) In paragraph (3), “marketing authorisation” means—

(a)a marketing authorisation issued by a competent authority in accordance with the 2001 Directive; F134...

[F135(aa)a UK marketing authorisation; or]

F134(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) Paragraph (1) does not apply to a person who, in connection with the importation of a medicinal product F136...—

(a)provides facilities solely for transporting the product; or

(b)acting as an import agent, imports the medicinal product solely to the order of another person who holds a manufacturer's licence authorising the importation of the product.

(6) Paragraph (1) does not apply to a person who imports a medicinal product for administration to himself or herself or to any other person who is a member of that person's household.

[F137(7) Paragraph (1) does not apply to imports into Northern Ireland from Great Britain of—

(a)special medicinal products, F138...

F138(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(8) For the purposes of paragraph (7) a medicinal product has been released for sale, supply or distribution where, after the stage of manufacturing has taken place, the product is the subject matter of a written or verbal agreement between two or more persons for the transfer of ownership, any other property right, or possession concerning the product, or where the product is the subject matter of an offer to a person to conclude such an agreement.]

[F139(9) Paragraph (1)(d) does not apply to the importation of a medicinal product into Northern Ireland from Great Britain by the holder of a wholesale dealer’s licence, where the following conditions are met—

(a)the medicinal product has undergone—

(i)in an EEA State, the quality control testing provided for by Article 51 of the 2001 Directive, or

(ii)in the United Kingdom, checks in accordance with these Regulations and the requirements of the marketing authorisation relating to the product and that these are appropriately certified;

(b)the batch release of the medicinal product has been undertaken—

(i)in Northern Ireland or an EEA State, by a qualified person in accordance with Article 51(1) of the 2001 Directive, and it is accompanied by the appropriate control reports, or

(ii)in Great Britain, by a qualified person applying equivalent standards;

(c)the medicinal product has a UKMA(UK) or UKMA(NI); [F140and]

(d)the importation of the medicinal product is with a view to its sale or supply in Northern Ireland only; F141...

F141(e). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ]

[F142(10) Regulation 17A sets out additional requirements in relation to the manufacture or assembly of MM medicinal products.

(11) Regulation 17B sets out additional requirements in relation to the manufacture or assembly of POC medicinal products.]

Textual Amendments

F136Words in reg. 17(5) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 14(5) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 9(d))

[F143Manufacturing of MM medicinal productsU.K.

17A.  A person may not manufacture or assemble an MM medicinal product unless—

(a)it is specified in a manufacturer’s licence (MM); and

(b)there is an MM master file relating to that product and it is manufactured or assembled in accordance with that master file.

Textual Amendments

Manufacturing of POC medicinal productsU.K.

17B.  A person may not manufacture or assemble a POC medicinal product unless—

(a)it is specified in a manufacturer’s licence (POC); and

(b)there is a POC master file relating to that product and it is manufactured or assembled in accordance with that master file.]

Textual Amendments

[F144Wholesale dealing in medicinal productsU.K.

18.—(1) A person may not except in accordance with a licence (a “wholesale dealer’s licence”)—

(a)distribute a medicinal product by way of wholesale dealing; F145...

(b)possess a medicinal product for the purpose of such [F146distribution; F147...]

[F148(c)import a medicinal product into Great Britain from an approved country for import] [F149; or

(d)supply a listed NIMAR product from Great Britain to Northern Ireland.]

(2) Paragraph (1)—

(a)does not apply—

(i)to anything done in relation to a medicinal product by the holder of a manufacturer’s licence in respect of that product,

(ii)where the product concerned is an investigational medicinal product, or

(iii)if the product is a radiopharmaceutical in which the radionuclide is in the form of a sealed source; and

(b)is subject to regulation 19.

[F150(2A) Paragraph (1)(c) does not apply to imports into Great Britain from an EEA State of medicinal products that have been released for sale, supply or distribution in an EEA State or the United Kingdom before IP completion day.

(2B) For the purposes of paragraph (2A) a medicinal product has been released for sale, supply or distribution where, after the stage of manufacturing has taken place, the product is the subject matter of a written or verbal agreement between two or more persons for the transfer of ownership, any other property right, or possession concerning the product, or where the product is the subject matter of an offer to a person to conclude such an agreement.]

(3) Distribution of a medicinal product by way of wholesale dealing, or possession for the purpose of such distribution, is not to be taken to be in accordance with a wholesale dealer’s licence unless the distribution is carried on, or as the case may be the product held, at premises located in the UK and specified in the licence.

(4) In these Regulations a reference to distributing a product [F151(including a listed NIMAR product)] by way of wholesale dealing is a reference to—

(a)selling or supplying it; or

(b)procuring or holding it or exporting it for the purposes of sale or supply,

to a person who receives it for a purpose within paragraph (5) [F152(but this is subject to paragraph (5A))].

(5) Those purposes are—

(a)selling or supplying the product; or

(b)administering it or causing it to be administered to one or more human beings,

in the course of a business carried on by that person.

[F153(5A) In these Regulations, references to distributing a product by way of wholesale dealing do not include any sale or supply that is treated by virtue of regulation 222A(2)(a) as or as part of a retail sale.]

[F154(6) A wholesale dealer’s licence does not authorise the distribution of a medicinal product by way of wholesale dealing, or possession of a medicinal product for the purpose of such distribution, unless—

(a)in the case of a product for sale or supply in Great Britain, a UKMA(GB) or UKMA(UK), certificate of registration or traditional herbal registration is in force in respect of the product, F155...

(b)in the case of a product for sale or supply in Northern Ireland, a UKMA(NI) or UKMA(UK) F156..., Article 126a authorisation, certificate of registration or traditional herbal registration is in force in respect of the product, [F157or

(c)in the case of a listed NIMAR product, a UKMA(GB) or UKMA(UK) is in force in respect of the product,]

but this is subject to the exceptions in regulation 43(6).]

F158(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ]

Textual Amendments

[F159Approved country for importU.K.

18A.—(1) The licensing authority must—

(a)publish a list of countries from which medicinal products may be imported under a wholesale dealing licence (“approved country for import list”); and

(b)only include in that list a country which is included in the approved country for batch testing list.

(2) In order to determine whether a country should be included in the approved country for import list, the licensing authority may, in particular, take into account—

(a)the country's system for ensuring that each batch of a medicinal product has been manufactured and checked in accordance with the requirements of its legislation and any authorisation in respect of that product;

(b)the country's rules for good distribution practice;

(c)the regularity of inspections to verify compliance with good distribution practice;

(d)the effectiveness of enforcement of good distribution practice;

(e)the regularity and rapidity of information provided by that country relating to non-compliant manufacturers and distributers of medicinal products;

(f)any on-site review of that country's regulatory system undertaken by the licensing authority;

(g)any on-site inspection of a manufacturing site in that country observed by the licensing authority; and

(h)any other relevant documentation available to the licensing authority.

(3) The licensing authority must—

(a)remove a country from the approved country for import list if that country is removed from the approved country for batch testing list;

(b)in any event review the countries it has included in the approved country for import list to determine if it is still satisfied that the country should remain on that list, and if it is not so satisfied, remove that country from the list; and

(c)undertake that review at least every three years beginning with the date on which that country is included in that list.]

Textual Amendments

Exemptions from requirement for wholesale dealer's licenceU.K.

19.—(1) Regulation 18 does not apply to the sale or offer for sale of a medicinal product by way of wholesale dealing, or possession for the purpose of such sale or offer, where paragraph (2) applies and the person selling or offering the product for sale is—

[F160(a)the holder of—

(i)in the case of a product for sale or supply in Great Britain [F161(including a listed NIMAR product for sale or supply from Great Britain to Northern Ireland)], a UKMA(GB), a UKMA(UK), a COR(GB), a COR(UK), a THR(GB) or a THR(UK) (an “authorisation”) which relates to the product, or

(ii)in the case of a product for sale or supply in Northern Ireland, a UKMA(NI), a UKMA(UK), a COR(NI), a COR(UK), a THR(NI), a THR(UK) F162... or an Article 126a authorisation (an “authorisation”) which relates to the product,

including a holder of an authorisation who manufactured or assembled the product; or]

(b)a person who is not the holder of an authorisation in relation to the product but manufactured or assembled the product [F163in the United Kingdom] to the order of a person who is the holder of an authorisation relating to the product.

(2) This paragraph applies if—

(a)until the sale, the medicinal product has been kept on the premises of the person who manufactured or assembled the product (in this regulation referred to as “authorised premises”); and

(b)those premises are premises authorised for use for manufacture or assembly by that person's manufacturer's licence.

(3) For the purposes of this regulation, a medicinal product is regarded as having been kept on authorised premises at a time when—

(a)it was being moved from one set of authorised premises to another, or from one part of authorised premises to another part; or

(b)it was being moved from authorised premises by way of delivery to a purchaser.

(4) Regulation 18 does not apply to a person who in connection with the importation of a medicinal product—

(a)provides facilities solely for transporting the product; or

(b)acting as an import agent, handles the product where the product is imported solely to the order of another person who intends to sell the product or offer it for sale by way of wholesale dealing or to distribute it in any other way.

[F164(4A) Regulation 18 does not apply in connection with the distribution by way of wholesale dealing of a medicinal product to be used for [F165vaccination against an infectious disease], where the person distributing the medicinal product [F166(Person A)]—

(a)was supplied with the medicinal product for the purposes of the administration of it under relevant arrangements;

(b)is supplying the medicinal product for the purposes of the administration of it by the person to whom it is being supplied (or by a person employed or engaged by them) under relevant arrangements [F167(Person B)]; F168...

(c)is authorised by the body making the arrangements to supply the medicinal product as mentioned in sub-paragraph (b) under the relevant arrangements; [F169and]

[F170(d)conditions A and B in paragraphs (4E) and (4F) are met.]

F171(4B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4C) In this regulation, “relevant arrangements” means—

(a)arrangements for the provision of services as part of—

(i)in England, the health service as defined by section 275(1) of the National Health Service Act 2006,

(ii)in Scotland, the health service as defined by section 108(1) of the National Health Service (Scotland) Act 1978,

(iii)in Wales, the health service as defined by section 206(1) of the National Health Service (Wales) Act 2006, and

(iv)in Northern Ireland, the system of health and social care promoted under section 2(1) of the Health and Social Care (Reform) Act (Northern Ireland) 2009; or

(b)arrangements for the provision of services (otherwise than as mentioned in sub-paragraph (a)) as part of the medical services of Her Majesty’s Forces.

[F172(4E) Condition A is that supply between Person A and Person B is agreed with the body making the arrangements to supply the medicinal product and the distribution occurs in exceptional circumstances, which are such that Person A and Person B are satisfied, having made appropriate enquiries, that—

(a)there is an urgent public health need for a patient to have administered to them the medicinal product on a particular occasion that the distribution would facilitate;

(b)there is no other way that the patient could receive treatment with the medicinal product without undue delay; and

(c)there is no suitable alternative medicinal product that the patient could receive treatment with without undue delay.

(4F) Condition B is that the medicinal product remains in its manufacturer’s original outer packaging, and is stored and transported, in accordance with the terms of its marketing authorisation.]]

F173(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F174(6) Regulation 18 does not apply to a person (“P”) who imports a medicinal product into Great Britain from an approved country for import for administration to P or to any other person who is a member of P’s household.]

Textual Amendments

F168Word in reg. 19(4A)(b) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 6(2)(b)(ii)

F172Reg. 19(4E)(4F) substituted for reg. 19(4D) (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 6(4)

Mixing of medicinesU.K.

20.—(1) Regulation 17(1) (manufacturing of medicinal products) does not apply to the mixing of medicines by—

(a)a nurse independent prescriber;

(b)a pharmacist independent prescriber;

(c)a supplementary prescriber, if the mixing of medicines forms part of the clinical management plan for an individual patient;

[F175(ca)physiotherapist independent prescriber;

(cb)podiatrist independent prescriber;]

[F176(cc)a therapeutic radiographer independent prescriber;]

[F177(cd)a paramedic independent prescriber;]

(d)a person acting in accordance with the written directions of a—

(i)doctor,

(ii)dentist,

(iii)nurse independent prescriber, F178...

[F179(iv)pharmacist independent prescriber,

(v)physiotherapist independent prescriber, F180...

(vi)podiatrist independent prescriber; or]

[F181(vii)therapeutic radiographer independent prescriber; or]

[F182(viii)paramedic independent prescriber; or]

(e)a person acting in accordance with the written directions of a supplementary prescriber, if the mixing of medicines forms part of the clinical management plan for an individual patient.

(2) In this regulation “mixing of medicines” means [F183the combining together of two or more medicinal products, none of which are MM medicinal products nor POC medicinal products] for the purposes of administering them to meet the needs of an individual patient.

Textual Amendments

F178Word in reg. 20(1)(d)(iii) omitted (20.8.2013) by virtue of The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 7(b)

F179Reg. 20(1)(d)(iv)-(vi) substituted for reg. 20(1)(d)(iv) (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 7(c)

F180Word in reg. 20(1)(d)(v) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 5(2)(b)(i) and word in reg. 20(1)(d)(v) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 5(2)(b)(i)

F181Reg. 20(1)(d)(vii) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 5(2)(b)(ii) and reg. 20(1)(d)(vii) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 5(2)(b)(ii)

F182Reg. 20(1)(d)(viii) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 4(2)(b) and reg. 20(1)(d)(viii) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 4(2)(b)

Application for manufacturer's or wholesale dealer's licenceU.K.

21.—(1) An application for a grant of a licence under this Part must—

(a)be made to the licensing authority;

(b)be made in the way and form specified in Schedule 3; and

(c)contain or be accompanied by the information, documents, samples and other material specified in that Schedule.

(2) An application must indicate the descriptions of medicinal products in respect of which the licence is required, either by specifying the descriptions of medicinal products in question or by way of an appropriate general classification.

Factors relevant to determination of application for manufacturer's or wholesale dealer's licenceU.K.

22.—(1) In dealing with an application for a manufacturer's licence the licensing authority must in particular take into consideration—

(a)the operations proposed to be carried out under the licence;

(b)the premises in which those operations are to be carried out;

(c)the equipment which is or will be available on those premises for carrying out those operations;

(d)the qualifications of the persons under whose supervision the operations will be carried out; and

(e)the arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of, medicinal products manufactured or assembled in pursuance of the licence.

[F184(1A) In dealing with an application for a manufacturer’s licence (MM) the licensing authority must, in addition to the matters specified in paragraph (1), take into consideration the arrangements made, or to be made, for—

(a)supervising and controlling operations at a modular unit specified in the application; and

(b)ensuring that manufacture or assembly is under appropriate control so that the MM medicinal product consistently meets the requirements in the MM master file when manufactured at that modular unit.

(1B) In dealing with an application for a manufacturer’s licence (POC) the licensing authority must, in addition to the matters specified in paragraph (1), take into consideration the arrangements made, or to be made, for—

(a)supervising and controlling operations at a POC site specified in the application; and

(b)ensuring that manufacture or assembly is under appropriate control so that the POC medicinal product consistently satisfies the requirements in the POC master file when manufactured at that POC site.]

(2) In dealing with an application for a wholesale dealer's licence the licensing authority must in particular take into consideration—

(a)the premises on which medicinal products of the descriptions to which the application relates will be stored;

(b)the equipment which is or will be available for storing medicinal products on those premises;

(c)the equipment and facilities which are or will be available for distributing medicinal products from those premises; and

(d)the arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of, medicinal products stored on or distributed from those premises.

Textual Amendments

Grant or refusal of licenceU.K.

23.—(1) Subject to the following provisions of these Regulations, on an application to the licensing authority for a licence under this Part the licensing authority may—

(a)grant a licence containing such provisions as it considers appropriate; or

(b)refuse to grant a licence if having regard to the provisions of these Regulations F185... it considers it necessary or appropriate to do so.

(2) The licensing authority must grant or refuse an application for a licence under this Part within the period of 90 days beginning immediately after the day on which it receives the application.

(3) Paragraph (2) applies to an application only if the requirements of Schedule 3 have been met.

(4) If a notice under regulation 30 requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (2).

(5) In paragraph (4), the “information period” means the period—

(a)beginning with the day on which the notice is given, and

(b)ending with the day on which the licensing authority receives the information or the applicant shows to the licensing authority's satisfaction that the applicant is unable to provide it.

(6) The licensing authority must give the applicant a notice stating the reasons for its decision in any case where—

(a)the licensing authority refuses to grant an application for a licence; or

(b)the licensing authority grants a licence otherwise than in accordance with the application and the applicant requests a statement of its reasons.

Textual Amendments

Standard provisions of licencesU.K.

24.—(1) The standard provisions set out in Schedule 4 may be incorporated by the licensing authority in a licence under this Part granted on or after the date on which these Regulations come into force.

(2) The standard provisions may be incorporated in a licence with or without modifications and either generally or in relation to medicinal products of a particular class.

[F186(3) In Schedule 4, in relation to a licence holder in Great Britain, references to the principles and guidelines set out in the Good Manufacturing Practice Directive are to those principles and guidelines as they apply under or by virtue of regulation B17.]

Textual Amendments

Duration of licenceU.K.

25.  A licence granted under this Part remains in force until—

(a)the licence is revoked by the licensing authority; or

(b)the licence is surrendered by the holder.

General power to suspend, revoke or vary licencesU.K.

26.—(1) The licensing authority may in accordance with the procedure specified in regulation 27—

(a)suspend a licence under this Part for such period as the authority thinks fit;

(b)revoke a licence under this Part; or

(c)vary the provisions of a licence under this Part.

(2) The suspension or revocation of a licence may be—

(a)total;

(b)limited to medicinal products of one or more descriptions; F187...

(c)limited to medicinal products manufactured, assembled or stored on specified premises or a specified part of any premises;

[F188(d)in the case of a manufacturer’s licence (MM), limited to modular units specified in the MM master file associated with the licence; or

(e)in the case of a manufacturer’s licence (POC), limited to POC sites specified in the POC master file associated with the licence.]

(3) The powers conferred by this regulation may not be exercised in relation to a manufacturer's licence or a wholesale dealer's licence except on one or more of the grounds specified in—

(a)paragraph (4) (in relation to either a manufacturer's licence or a wholesale dealer's licence);

(b)paragraph (5) (in relation to a manufacturer's licence); or

(c)paragraph (6) (in relation to a wholesale dealer's licence).

(4) Those grounds are that—

(a)the information in the application as a result of which the licence was granted was false or incomplete in a material respect;

(b)a material change of circumstances has occurred in relation to any of the matters stated in the application;

(c)the holder of the licence has materially contravened a provision of it; or

(d)the holder of the licence has without reasonable excuse failed to supply information to the licensing authority with respect to medicinal products of a description to which the licence relates when required to do so under regulation 30(2).

(5) In relation to a manufacturer's licence, the powers conferred by this regulation may also be exercised on either or both of the following grounds—

[F189(a)that the holder of the manufacturer's licence has manufactured or assembled medicinal products to the order of a person who holds—

(i)in the case of a product for sale or supply in Great Britain, a UKMA(GB), a UKMA(UK), a COR(GB), a COR(UK), a THR(GB) or a THR(UK) (an “authorisation”), F190...

(ii)in the case of a product for sale or supply in Northern Ireland, a UKMA(NI), a UKMA(UK), a COR(NI), a COR(UK), a THR(NI) or a THR(UK), an EU marketing authorisation or an Article 126a authorisation (an “authorisation”), [F191or

(iii)in the case of a listed NIMAR product, a UKMA(GB) or UKMA(UK) (an “authorisation”),]

and has habitually failed to comply with the provisions of that authorisation; or]

(b)that the holder of the manufacturer's licence does not have appropriate facilities to carry out processes of manufacture or assembly authorised by the licence.

(6) In relation to a wholesale dealer's licence, the powers conferred by this regulation may also be exercised on the grounds that the equipment and facilities available to the holder of the licence for storing or distributing medicinal products are inadequate to maintain the quality of medicinal products of one or more descriptions to which the licence relates.

Textual Amendments

Procedure where licensing authority proposes to suspend, revoke or vary licenceU.K.

27.—(1) This regulation applies where—

(a)the provisions of regulation 28 do not apply; and

(b)the licensing authority proposes to suspend, vary or revoke a licence under regulation 26.

(2) The licensing authority must notify the licence holder in writing of—

(a)its proposal;

(b)the reasons for it; and

(c)the date (which must be no earlier than 28 days from the notice given by the licensing authority) on which it is proposed that the suspension, revocation or variation should take effect.

(3) The licence holder may before the date specified in the notice—

(a)make written representations to the licensing authority with respect to the proposal; or

(b)notify the licensing authority that the holder wishes the licensing authority to submit the proposal to review upon oral representations.

(4) If the licence holder makes written representations in accordance with paragraph 3(a) the licensing authority must take those representations into account before making a decision in the matter.

[F192(5) If the licence holder notifies the licensing authority that the holder wishes the licensing authority to submit the proposal to review upon oral representations in accordance with paragraph (3)(b)—

(a)Schedule 5 has effect; and

(b)the licence holder must pay a fee for a review upon oral representations in accordance with the Fees Regulations.]

(6) If the licensing authority proceeds to suspend, revoke or vary a licence in accordance with the provisions of regulation 26 it must give a notice to the licence holder.

(7) The notice must—

(a)give particulars of the suspension, revocation or variation; and

(b)give reasons for the decision to suspend, revoke or vary the licence.

(8) Paragraphs (6) and (7) are without prejudice to any requirement of Schedule 5 as to notification.

Textual Amendments

[F193Effect of suspension or variation relating to modular unit or POC siteU.K.

27A.—(1) If the licensing authority suspends or varies a manufacturer’s licence (MM) in accordance with regulation 26(2)(d) so that manufacturing or assembly is suspended, or no longer authorised, at a modular unit, the licence holder may not approve that unit for the purpose of manufacturing or assembly of the MM medicinal product other than by way of an application under regulation 29.

(2) If the licensing authority suspends or varies a manufacturer’s licence (POC) in accordance with regulation 26(2)(e) so that manufacturing or assembly is suspended, or no longer authorised, at a POC site, the licence holder may not approve that site for the purpose of manufacturing or assembly of the POC medicinal product other than by way of an application under regulation 29.]

Textual Amendments

Suspension of licence in cases of urgencyU.K.

28.—(1) Notwithstanding anything in the preceding provisions of this Part, where it appears to the licensing authority that in the interests of safety it is necessary to suspend a licence under this Part with immediate effect, the licensing authority may do so for a period not exceeding three months.

(2) This paragraph applies where—

(a)a licence has been suspended under paragraph (1); and

(b)it appears to the licensing authority that it is necessary to consider whether the licence should be further suspended, revoked or varied.

(3) Where paragraph (2) applies, the licensing authority must proceed as set out in regulation 27 (but this is subject to paragraphs (4) and (5)).

(4) Paragraph (5) applies where, in circumstances where paragraph (2) applies, the licensing authority proceeds as set out in regulation 27 and any proceedings under that regulation have not been finally disposed of before the end of the period for which the licence was suspended under paragraph (1) or further suspended under paragraph (5).

(5) If it appears to the licensing authority to be necessary in the interests of safety to do so, the authority may further suspend the licence for a period which (in the case of each further suspension) is not to exceed three months.

(6) In the event that any challenge against a decision under regulation 27 to suspend, vary or revoke the licence is made on an application to the High Court under regulation 322(4) paragraph (5) shall apply, but this is without prejudice to regulation 322(6)(a).

Variation of licence on the application of the holderU.K.

29.—(1) This regulation applies if the holder of a licence under this Part applies to the licensing authority for a variation of the licence.

(2) The application must—

(a)be in writing;

(b)specify the variation requested;

(c)be signed by or on behalf of the applicant;

(d)be accompanied by such information as may be required to enable the licensing authority to consider the application; and

(e)be accompanied by the required fee (if any).

[F194(2A) In the case of an application of a type specified in paragraph (2C), the information to be provided under paragraph (2)(d) must include the information specified in paragraph 1A(2) of Schedule 3.

(2B) In the case of an application of a type specified in paragraph (2D), the information to be provided under paragraph (2)(d) must include the information specified in paragraph 1B(2) of Schedule 3.

(2C) The following types of application are specified for the purpose of paragraph (2A) and (2E)—

(a)an application to vary the licence so that it relates to the manufacture or assembly of MM medicinal products;

(b)an application to vary a manufacturer’s licence (MM) to add a new MM medicinal product.

(2D) The following types of application are specified for the purpose of paragraphs (2B) and (2F)—

(a)an application to vary the licence so that it relates to the manufacture or assembly of POC medicinal products;

(b)an application to vary a manufacturer’s licence (POC) to add a new POC medicinal product.

(2E) In dealing with an application of a type specified in paragraph (2C), the licensing authority must take into consideration the arrangements made or to be made for—

(a)supervising and controlling operations at a modular unit specified in the application; and

(b)ensuring that manufacture or assembly is under appropriate control so that the MM medicinal product consistently satisfies the requirements in the MM master file when manufactured at that modular unit.

(2F) In dealing with an application of a type specified in paragraph (2D), the licensing authority must take into consideration the arrangements made or to be made for—

(a)supervising and controlling operations at a POC site specified in the application; and

(b)ensuring that manufacturing or assembly is under appropriate control so that the POC medicinal product consistently satisfies the requirements in the POC master file when manufactured at that POC site.]

(3) The licensing authority must consider an application made in accordance with this regulation.

(4) If paragraph (5) applies, the licensing authority must vary the licence or refuse to vary it before the end of the period allowed for considering the application.

(5) This paragraph applies to a variation which would have the effect of altering—

(a)the types of medicinal product in respect of which the licence was granted;

(b)any operation carried out under the licence; F195...

(c)any premises, equipment or facilities in respect of which the licence was [F196granted; or]

[F197(d)the responsible person (import) under regulation 45AA.]

(6) The period allowed for consideration of an application under this regulation is—

(a)in a case where the licensing authority considers that it is necessary to inspect premises to which the licence relates, 90 days beginning with the day after the date when the licensing authority receives the application; and

(b)in any other case 30 days beginning with that day.

(7) The licensing authority may give a notice to the applicant requiring the applicant to supply further information in connection with the application.

(8) If a notice under paragraph (7) requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (6).

(9) In paragraph (8), the “information period” means the period—

(a)beginning with the day on which the notice is given; and

(b)ending with the day on which the licensing authority receives the information or the applicant shows to the licensing authority's satisfaction that the applicant is unable to provide it.

(10) Nothing in this regulation affects the powers conferred by regulation 26.

Textual Amendments

[F198Variation of MM master fileU.K.

29A.  Except where regulation 27A(1) applies, the holder of a manufacturer’s licence (MM) may amend the information in the MM master file provided in accordance with paragraph 1A(2)(a), (c) and (h) to (k) of Schedule 3 without applying to the licensing authority for a variation under regulation 29.

Textual Amendments

Variation of POC master fileU.K.

29B.  Except where regulation 27A(2) applies, the holder of a manufacturer’s licence (POC) may amend the information in the POC master file provided in accordance with paragraph 1B(2)(a), (b) and (g) to (j) of Schedule 3 without applying to the licensing authority for a variation under regulation 29.]

Textual Amendments

Provision of informationU.K.

30.—(1) Where an application has been made to the licensing authority for a licence under this Part, the licensing authority may, before determining the application, require the applicant to provide such information as the licensing authority thinks necessary, within the period specified by the licensing authority.

(2) The licensing authority may give a notice to the holder of a licence under this Part, requiring the holder to provide information of a kind specified in the notice within the period specified in the notice.

(3) A notice under paragraph (2) may not be given to the holder of a licence unless it appears to the licensing authority, or representations are made to the licensing authority by the Commission, an expert advisory group of the Commission, or an expert committee appointed by the licensing authority, that it is necessary for the licensing authority to consider whether the licence should be varied, suspended or revoked.

(4) A notice under paragraph (2) may specify information which the licensing authority, or the Commission, an expert advisory group of the Commission, or an expert committee appointed by the licensing authority, thinks necessary for considering whether the notice should be varied, suspended or revoked.

Miscellaneous and offencesU.K.

Certification of manufacturer's licenceU.K.

31.—(1) The licensing authority must issue a certificate in accordance with the following paragraphs of this regulation in relation to a manufacturer's licence relating to the manufacture or assembly of medicinal products if requested to do so by—

(a)subject to paragraph (5), the holder of the licence;

(b)a person who intends to export a medicinal product manufactured or assembled by the holder under the licence; or

(c)the competent authorities of a country other than [F199the United Kingdom] into which a medicinal product manufactured or assembled under the licence is, or is proposed to be, imported.

(2) The certificate must contain —

(a)information sufficient to identify the holder of the manufacturer's licence;

(b)details of the medicinal products that may be manufactured or assembled under the licence; and

(c)any other information concerning the holder, the product or the licence that the licensing authority thinks it appropriate to include, including information relating to clinical trials.

(3) If—

(a)a request is made—

(i)under paragraph (1)(a) in relation to the export or the proposed export of a product, or

(ii)under paragraph (1)(b) or (c); and

(b)there is a [F200UK marketing authorisation F201..., Article 126a authorisation] or a traditional herbal registration in force for any product to which the licence relates,

the certificate must be accompanied by the summary of the product characteristics relating to that product.

(4) The licensing authority may restrict the information provided under sub-paragraphs (2)(a) and (b) and paragraph (3) to information relating to the specific medicinal products mentioned in the request made under paragraph (1).

(5) A licence holder who makes a request under paragraph (1) must—

(a)produce to the licensing authority a [F202UK marketing authorisation F203..., Article 126a authorisation], certificate of registration or traditional herbal registration in relation to any product to which the certificate is to relate; or

(b)make a declaration to the licensing authority explaining why no [F204UK marketing authorisation F205..., Article 126a authorisation], certificate of registration or traditional herbal registration is available.

(6) The licensing authority must have regard to the prevailing administrative arrangements of the World Health Organisation when issuing the certificate.

Textual Amendments

Sale and supply of starting materialsU.K.

F20632.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Offence concerning data for advanced therapy medicinal productsU.K.

33.—(1) A person who is, or immediately before its revocation or suspension was, the holder of a manufacturer's licence relating to an advanced therapy medicinal product is guilty of an offence if the person fails to—

(a)keep the data referred to in [F207paragraph 8 of Schedule 6] in accordance with the requirements of [F208paragraph 9 of that Schedule]; or

(b)transfer the data referred to in [F209paragraph 8] to the licensing authority in the event of that person's bankruptcy or liquidation,

but this is subject to paragraphs (2) and (3).

(2) Sub-paragraph (1)(b) does not apply if—

(a)the person is bankrupt or in liquidation and has transferred the data to another person; or

(b)the period for which the person was required to keep the data in accordance with the requirements of [F210paragraph 9] mentioned in sub-paragraph (1)(a) has expired.

(3) It is a defence for a person charged with an offence under paragraph (1) to prove that the person took all reasonable precautions and exercised all due diligence to avoid commission of the offence.

(4) Where evidence is adduced that is sufficient to raise an issue with respect to the defence in paragraph (3), the court or jury must presume that the defence is satisfied unless the prosecution proves beyond reasonable doubt that it is not.

Textual Amendments

Offences: breach of regulations and false information and defence concerning starting materialsU.K.

34.—(1) A person is guilty of an offence if the person contravenes the provisions of regulation 17(1) [F211or 18(1)].

(2) A person is guilty of an offence if the person knowingly gives false information in response to a notice under regulation 30(1).

(3) A person is guilty of an offence if, without reasonable excuse, the person fails to comply with a notice under regulation 30(2).

(4) The defence in paragraph (5) applies to a person who is charged under paragraph (1) with an offence of contravening regulation 17(1) (prohibition on manufacturing a medicinal product except in accordance with a licence) by virtue of a breach of regulation [F21237(3)] (requirement that active substances used as starting materials are manufactured or assembled in accordance with the Good Manufacturing Practice Directive).

(5) It is a defence for the person to show that the person could not, by taking all reasonable precautions and exercising all due diligence, have discovered that an active substance was not manufactured in accordance with regulation [F21237(3)].

Textual Amendments

PenaltiesU.K.

35.—(1) A person guilty of an offence under regulation 33(1) or regulation 34(1) or (2) is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment to a fine, to imprisonment for a term not exceeding two years, or to both.

(2) A person guilty of an offence under regulation 34(3) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.

Conditions for holding a manufacturer's licenceU.K.

Conditions for manufacturer's licenceU.K.

36.—(1) Regulations 37 to 41 apply to the holder of a manufacturer's licence (referred to in those regulations as “the licence holder”) and have effect as if they were provisions of the licence (but the provisions specified in paragraph (2) do not apply to the holder of a manufacturer's licence insofar as the licence relates to the manufacture or assembly of exempt advanced therapy medicinal products).

(2) Those provisions are regulations [F21337(3)], 38, 39(6)(a) and (8) , 40 and 41.

(3) The requirements of Part 1 of Schedule 6 apply to the holder of a manufacturer's licence insofar as the licence relates to the manufacture or assembly of exempt advanced therapy medicinal products, and have effect as if they were provisions of the licence.

F214(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F214(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F214(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F214(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F215Manufacturing and assemblyU.K.

37.—(1) This regulation applies in relation to a manufacturer’s licence relating to the manufacture or assembly of medicinal products.

(2) The licence holder must comply with the principles and guidelines for good manufacturing practice set out in the Good Manufacturing Practice Directive [F216which apply under or by virtue of regulation B17].

(3) Unless paragraph (10) applies, the licence holder shall use active substances as starting materials only if—

(a)those substances have been manufactured in accordance with good manufacturing practice for active substances; and

(b)those substances have been distributed in accordance with the guidelines on good distribution practice for active substances.

(4) The licence holder shall verify—

(a)that the manufacturer or distributor of an active substance used by the licence holder has complied with the requirements of good manufacturing practice and good distribution practice for active substances by means of audits performed—

(i)directly by the licence holder, or

(ii)by a person acting on behalf of the licence holder under a contract;

[F217(b)that unless the active substance is imported into Great Britain from a country other than an approved country for import or into Northern Ireland from a country other than an EEA State from a third country, any manufacturers, importers or distributors supplying active substances to the licence holder—

(i)in the case of a product imported into Great Britain, are registered with the appropriate authority for the registration of such persons in the approved country for import, and

(ii)in the case of a product imported into Northern Ireland, are registered with the competent authority of a member State in which they are established; and]

(c)the authenticity and quality of the active substance.

(5) The licence holder shall ensure that—

(a)excipients are suitable for use in a medicinal product by—

(i)ascertaining what the appropriate good manufacturing practice is, and

(ii)ensuring that the ascertained good manufacturing practice is applied;

(b)the suitability of the excipient is ascertained on the basis of a formalised risk assessment as described F218[F219... in the guidelines which apply under or by virtue of regulation C17 ] [F220(including in the case of a listed NIMAR product for sale or supply from Great Britain to Northern Ireland)] ;

(c)the assessment under sub-paragraph (b) takes account of—

(i)the source,

(ii)requirements under other quality systems,

(iii)intended use of the excipients, and

(iv)previous instances of quality defects,

(d)the authenticity and quality of any excipient used is verified; and

(e)the measures taken under this paragraph are documented by the licence holder.

(6) The licence holder must maintain such staff, premises and equipment as are necessary for the stages of manufacture and assembly of medicinal products undertaken by the licence holder in accordance with—

(a)the manufacturer’s licence; F221...

[F222(aa)in the case of a product for supply as an EAMS medicinal product, the conditions attached to the EAMS scientific opinion in respect of the product; F223...]

[F224(ab)in the case of an MM medicinal product, the MM master file;

(ac)in the case of a POC medicinal product, the POC master file; and]

(b)[F225in the case of a product for sale or supply—

(i)in Great Britain [F226(including a listed NIMAR product for sale or supply from Great Britain to Northern Ireland)], the UKMA(GB), UKMA(UK), COR(GB), COR(UK), THR(GB) or THR(UK), or

(ii)in Northern Ireland, the UKMA(NI), UKMA(UK), COR(NI), COR(UK), THR(NI), THR(UK), EU marketing authorisations or Article 126a authorisations,

applying to the medicinal products.]

(7) The licence holder must not manufacture or assemble medicinal products, or classes of medicinal products, other than those specified in the licence.

(8) [F227Except in the case of an MM medicinal product or a POC medicinal product,] the licence holder must not manufacture or assemble medicinal products on premises other than those specified in the licence as approved by the licensing authority for the purpose.

(9) The licence holder must ensure that blood, or blood components, imported into the United Kingdom and used as a starting material or raw material in the manufacture of a medicinal product meet—

(a)the standards of quality and safety specified in [F228the Blood Quality and Safety Regulations 2005]; or

(b)equivalent standards.

(10) The requirements in paragraphs (3) to (5) do not apply in relation to the manufacture or assembly of special medicinal product to which regulation 167 (supply to fulfil special needs) applies [F229or an EAMS medicinal product to which regulation 167E(1) to (4) (EAMS medicinal product: manufacture, assembly, importation, distribution and supply) applies].

(11) The licence holder must immediately inform the [F230licensing authority] and, where applicable, the [F231UK] marketing authorisation holder, of medicinal products which come within the scope of manufacturing authorisation which the licence holder—

(a)knows or suspects; or

(b)has reasonable grounds for knowing or suspecting,

to be falsified.]

Textual Amendments

[F232Manufacturing and assembly of MM medicinal products: additional requirementsU.K.

37A.  In addition to the requirements in regulation 37, the holder of a manufacturer’s licence (MM) must ensure that—

(a)the requirements in regulation 37(2) to (7), (9) and (11) are complied with in relation to manufacturing or assembly carried out at the modular units specified in the MM master file; and

(b)only the MM medicinal products specified in the licence are manufactured or assembled at the modular units specified in the MM master file.

Textual Amendments

Manufacturing and assembly of POC medicinal products: additional requirementsU.K.

37B.  In addition to the requirements in regulation 37, the holder of a manufacturer’s licence (POC) must ensure that—

(a)the requirements in regulation 37(2) to (7), (9) and (11) are complied with in relation to manufacturing or assembly carried out at the POC sites specified in the POC master file;

(b)only the POC medicinal products specified in the licence are manufactured or assembled at the POC sites specified in the POC master file; and

(c)a POC medicinal product specified in the licence is only manufactured at a POC site specified in the POC master file.]

Textual Amendments

Imports from states other than EEA States [F233/ countries other than approved countries for import] U.K.

38.—(1) This regulation applies in relation to a manufacturer's licence relating to the import of medicinal products.

(2) The licence holder must comply with the conditions set out in this regulation in relation to the import of medicinal products [F234from—

(a)in the case of an import into Great Britain, a country other than an approved country for import, or

(b)in the case of an import into Northern Ireland, a country other than an EEA State].

(3) The licence holder must—

(a)comply with the principles and guidelines on good manufacturing practice in the Good Manufacturing Practice Directive in so far as they are relevant to the import of medicinal products; and

(b)ensure that active substances have been used as starting materials in the manufacture of medicinal products, other than special medicinal products, imported from [F235, in the case of an import into Great Britain, a country other than an approved country for import and in the case of an import into Northern Ireland, a country other than an EEA State] only if those substances have been manufactured or assembled in accordance with [F236good manufacturing practice for active substances].

Textual Amendments

F236Words in reg. 38(3)(b) substituted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 4 and words in reg. 38(3)(b) substituted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 4

Further requirements for manufacturer's licenceU.K.

39.—(1) This regulation applies in relation to any manufacturer's licence.

(2) The licence holder must maintain such staff, premises, equipment and facilities for the handling, control, storage and distribution of medicinal products under the licence as are appropriate in order to maintain the quality of the medicinal products.

(3) The licence holder must ensure that any arrangements made for the handling, control, storage and distribution of medicinal products are adequate to maintain the quality of the products.

(4) [F237Except in the case of an MM medicinal product or a POC medicinal product,] the licence holder must not handle, control, store or distribute medicinal products on any premises other than those specified in the licence as approved by the licensing authority for the purpose.

(5) [F238Except in the case of an MM medicinal product or a POC medicinal product,] the licence holder must inform the licensing authority before making a material alteration to the premises or facilities used under the licence, or to the purposes for which those premises or facilities are used.

[F239(5A) The holder of a manufacturer’s licence (MM) must ensure that the medicinal products specified in the licence are not handled, controlled, stored or distributed on any premises other than the MM control site and the modular units specified in the MM master file.

(5B) The holder of a manufacturer’s licence (MM) must inform the licensing authority before making a material alteration to the premises or facilities at the MM control site, or to any modular unit specified in the MM master file, or to the purposes for which those premises or facilities are used.

(5C) The holder of a manufacturer’s licence (POC) must ensure that the medicinal products specified in the licence are not handled, controlled, stored or distributed on any premises other than the POC control site and those specified in the POC master file.

(5D) The holder of a manufacturer’s licence (POC) must inform the licensing authority before making a material alteration to the premises or facilities at the POC control site, or to the purposes for which those premises or facilities are used.

(5E) Paragraphs (5A) and (5C) do not apply to anything done in the course of the business of a hospital that consists of dealing with a medicine or making it ready for use for the purposes of its final supply or administration to a patient.]

(6) The licence holder must inform the licensing authority of any proposed change to—

(a)the qualified person; and

(b)any person named in the licence as having responsibility for quality control.

(7) For the purposes of enabling the licensing authority to determine whether there are grounds for suspending, revoking or varying the licence, the licence holder must permit a person authorised in writing by the licensing authority to do anything that the licensing authority could have done for the purposes of verifying a statement made in an application for a licence.

[F240(8) In distributing a medicinal product by way of wholesale dealing, the licence holder must comply with the following as if they are a holder of a wholesale dealer’s licence—

(a)regulations 43(1), (2) and (5), 43ZA and 44(5) and (6)[F241.]

F242(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ]

Textual Amendments

Obligation to provide information relating to control methodsU.K.

40.—(1) This regulation applies in relation to any manufacturer's licence.

(2) The licensing authority may require the licence holder to provide the authority with proof of the control methods employed by the holder in relation to a medicinal product.

Requirements as to qualified personsU.K.

41.—(1) This regulation applies in relation to any manufacturer's licence.

(2) The licence holder must ensure that there is at the disposal of the holder at all times at least one qualified person who is responsible for carrying out, in relation to medicinal products manufactured, assembled or imported under the licence, the duties specified in Part 3 of Schedule 7.

(3) If the licence holder satisfies the requirements of Part 1 or 2 of Schedule 7 the licence holder may act as a qualified person.

(4) A qualified person may be treated by the licence holder as satisfying the requirements of Part 1 or 2 of Schedule 7 if that person produces evidence that he or she—

(a)is a member of a body specified in paragraph (5); and

(b)is regarded by that body as satisfying those requirements.

(5) Those bodies are—

(a)the Society of Biology;

(b)the Royal Pharmaceutical Society;

(c)the Pharmaceutical Society of Northern Ireland;

(d)the Royal Society of Chemistry; and

(e)such other body as may be specified by the licensing authority for the purpose of this paragraph.

(6) Where the qualified person changes, the licence holder must give the licensing authority advance notification of—

(a)that change; and

(b)the name, address and qualifications of the new qualified person.

(7) The licence holder must not permit any person to act as a qualified person other than the person named in the licence or another person notified to the licensing authority under paragraph (6).

(8) Paragraph (9) applies if the licensing authority thinks, after giving the licence holder and a person acting as a qualified person the opportunity to make representations (orally or in writing), that the person—

(a)does not satisfy the requirements of Part 1 or 2 of Schedule 7 in relation to qualifications or experience;

(b)does not satisfy paragraph (b) of the definition of “qualified person” in regulation 8; or

(c)is failing to carry out the duties referred to in paragraph (2) adequately or at all.

(9) Where this paragraph applies, the licensing authority must notify the licence holder in writing that the person is not permitted to act as a qualified person.

(10) The licence holder must at all times provide and maintain such staff, premises and equipment as are necessary to enable the qualified person to carry out the duties referred to in paragraph (2).

(11) The licence holder is not obliged to meet the requirements of this regulation in relation to any activity under the licence which relates to special medicinal products or [F243, unless conditions attached in accordance with regulation 174A(1) provide otherwise,] to products authorised on a temporary basis under regulation 174 (supply in response to spread of pathogenic agents etc).

[F244(12) The licence holder is not obliged to meet the requirements of this regulation in relation to any activities under the licence which relate to EAMS medicinal products, unless the conditions attached to the scientific opinion in respect of that product in accordance with regulation 167C(2)(c) provide otherwise.]

Textual Amendments

Conditions for holding a wholesale dealer's licenceU.K.

Conditions for wholesale dealer's licenceU.K.

42.—(1) Regulations 43 to 45 [F245(not including regulation 43ZA)] [F246(in the case of a wholesale dealer’s licence held in Northern Ireland) or regulations 43 to 45AA [F247(including regulation 43ZA)] (in the case of a wholesale dealer’s licence held in Great Britain)] apply to the holder of a wholesale dealer's licence (referred to in those regulations as “the licence holder”) and have effect as if they were provisions of the licence (but the provisions specified in paragraph (2) do not apply to the holder of a wholesale dealer's licence insofar as the licence relates to exempt advanced therapy medicinal products).

[F248(2) Those provisions are regulations 43(2) and (8) and 44.]

(3) The requirements in Part 2 of Schedule 6 apply to the holder of a wholesale dealer's licence insofar as the licence relates to exempt advanced therapy medicinal products, and have effect as if they were provisions of the licence.

F249(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F250(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F251(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Obligations of licence holderU.K.

43.—[F252(1) The licence holder must comply with the guidelines on good distribution practice—

(a)in the case of a licence holder in Great Britain, published under, or that apply by virtue of, regulation C17;

(b)in the case of a licence holder in Northern Ireland, published by the European Commission in accordance with Article 84 of the 2001 Directive.]

(2) The licence holder must ensure, within the limits of the holder's responsibility, the continued supply of medicinal products to pharmacies, and other persons who may lawfully sell medicinal products by retail or supply them in circumstances corresponding to retail sale, so that the needs of patients in the United Kingdom are met.

(3) The licence holder must provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of medicinal products under the licence as are necessary—

(a)to maintain the quality of the products; and

(b)to ensure their proper distribution.

(4) The licence holder must inform the licensing authority of any proposed structural alteration to, or discontinuance of use of, premises to which the licence relates or which have otherwise been approved by the licensing authority.

(5) Subject to paragraph (6), the licence holder must not sell or supply a medicinal product, or offer it for sale or supply, unless—

[F253(a)in the case of a product for sale or supply—

(i)in Great Britain, there is a UKMA(GB), UKMA(UK), a COR(GB), a COR(UK), a THR(GB) or a THR(UK) (an “authorisation”), or

(ii)in Northern Ireland, there is a UKMA(NI), UKMA(UK), a COR(NI), a COR(UK), a THR(NI), a THR(UK) F254... or an Article 126a authorisation (an “authorisation”),

in force in relation to the product; and]

(b)the sale or supply, or offer for sale or supply, is in accordance with the authorisation.

(6) The restriction in paragraph (5) does not apply to—

(a)the sale or supply, or offer for sale or supply, of a special medicinal product [F255in the United Kingdom];

[F256(aa)the supply, or offer for supply, of an unauthorised EAMS medicinal product in the United Kingdom;]

(b)the export [F257from Northern Ireland] to an EEA State, or supply for the purposes of such export, of a medicinal product which may be placed on the market in that State without a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration by virtue of legislation adopted by that State under Article 5(1) of the 2001 Directive; F258...

[F259(ba)the export from Great Britain to an approved country for import, or supply for the purposes of such export, of a medicinal product which may be placed on the market in that country without—

(i)a marketing authorisation, certificate of registration or traditional herbal registration within the meaning of the 2001 Directive, by virtue of legislation adopted by that country under Article 5(1) of that Directive, where the approved country for import is an EEA State, or

(ii)such equivalent authorisation, certificate or registration in the approved country for import, under legislation in that country that makes provision that is equivalent to Article 5(1) of the 2001 Directive, where the approved country for import is not an EEA State.]

(c)the sale or supply, or offer for sale or supply, of an unauthorised medicinal product where the Secretary of State has temporarily authorised the distribution of the product under regulation 174; [F260or

[F261(d)the wholesale distribution of medicinal products—

(i)from Northern Ireland to a person in a country other than Great Britain or a country other than an EEA State; or

(ii)from Great Britain to a person in a country other than Northern Ireland or a country other than an approved country for import.]

(7) The licence holder must—

(a)keep documents relating to the sale or supply of medicinal products under the licence which may facilitate the withdrawal or recall from sale of medicinal products in accordance with paragraph (b);

(b)maintain an emergency plan to ensure effective implementation of the recall from the market of a medicinal product where recall is—

[F262(i)ordered by the licensing authority or—

(aa)in the case of a licence holder in Great Britain, by an appropriate authority for the licensing of medicinal products in an approved country for import;

(bb)in the case of a licence holder in Northern Ireland, by the competent authority of any EEA State, or]

[F263(ii)carried out in co-operation with the manufacturer of, or the holder of—

(aa)in the case of a product for sale or supply in Great Britain, the UKMA(GB) or UKMA(UK), certificate of registration or traditional herbal registration, or

(bb)in the case of a product for sale or supply in Northern Ireland, the UKMA(NI) or UKMA(UK) F264..., Article 126a authorisation, certificate of registration or traditional herbal registration,

for, the product; and]

[F265(c)keep records in relation to the receipt, dispatch or brokering of medicinal products, of—

(i)the date of receipt,

(ii)the date of despatch,

(iii)the date of brokering,

(iv)the name of the medicinal product,

(v)the quantity of the product received, dispatched or brokered,

(vi)the name and address of the person from whom the products were received or to whom they are dispatched,]

F266(vii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F265(8) A licence holder [F267in Northern Ireland] (“L”) who imports from another EEA State a medicinal product in relation to which L is not the holder of a marketing authorisation, Article 126a authorisation, certificate of registration or a traditional herbal registration shall—

(a)notify the intention to import that product to the holder of the authorisation and—

(i)in the case of a product which has been granted a marketing authorisation under Regulation (EC) No 726/2004, to the EMA; or

(ii)in any other case, the licensing authority; and

(b)pay a fee to the EMA in accordance with Article 76(4) of the 2001 Directive or the licensing authority as the case may be, in accordance with the Fees Regulations,

but this paragraph does not apply in relation to the wholesale distribution of medicinal products to a person in a [F268country other than an EEA State].]

[F269(8A) Paragraph (8B) applies to a person (“P”) who—

(a)imports into Great Britain a medicinal product, other than for the sole purpose of wholesale distribution of that product to a person in a country other than the United Kingdom; but

(b)is not the holder of a UK marketing authorisation, certificate of registration or traditional herbal registration in respect of that product.

(8B) Where this paragraph applies, P must—

(a)notify—

(i)the holder of any authorisation, certificate or registration, granted by an authority in the country from which the product is exported, to sell or supply that product in that country, and

(ii)the licensing authority,

of the intention to import that product; and

(b)pay a fee to the licensing authority in accordance with the Fees Regulations.]

(9) For the purposes of enabling the licensing authority to determine whether there are grounds for suspending, revoking or varying the licence, the licence holder must permit a person authorised in writing by the licensing authority, on production of identification, to carry out any inspection, or to take any samples or copies, which an inspector could carry out or take under Part 16 (enforcement).

F270[F271(10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F272(11) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(12) The licence holder must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities.

(13) The licence holder must immediately inform the licensing authority and, where applicable, the [F273UK marketing authorisation holder F274...], of medicinal products which the licence holder receives or is offered which the licence holder—

(a)knows or suspects; or

(b)has reasonable grounds for knowing or suspecting,

to be falsified.

(14) [F275Where the medicinal product is obtained through brokering—

(a)a licence holder in Great Britain must verify that the broker involved fulfils the requirements set out in regulation 45A(1)(b);

(b)a licence holder in Northern Ireland must verify that the broker involved is validly registered with the licensing authority or the competent authority of an EEA State.]

(15) In this regulation [F276as it applies in the case of a product for sale or supply in Northern Ireland], “marketing authorisation” means—

(a)a marketing authorisation issued by a competent authority in accordance with the 2001 Directive; or

(b)an EU marketing authorisation.]]

Textual Amendments

F258Word in reg. 43(6)(b) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 6(2)(a) and word in reg. 43(6)(b) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 6(2)(a)

F260Reg. 43(6)(d) and preceding word inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 6(2)(b) and reg. 43(6)(d) and preceding word inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 6(2)(b)

F271Reg. 43(10)-(15) substituted for reg. 43(10) (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 14(b)

[F277Obligations of licence holder in Great Britain supplying listed NIMAR products to Northern IrelandU.K.

43ZA.—(1) This regulation applies only to licence holders in Great Britain supplying listed NIMAR products to Northern Ireland.

(2) A licence holder must comply with the guidelines on good distribution practice, published under, or that apply by virtue of, regulation C17.

(3) So that the needs of patients in Northern Ireland are met, the licence holder must ensure, within the limits of the holder’s responsibility, the continued supply of listed NIMAR products to—

(a)registered pharmacies in Northern Ireland;

(b)any person who may lawfully sell those products by retail sale or may lawfully supply them in circumstances corresponding to retail sale in Northern Ireland;

(c)any person who may lawfully administer prescription only medicines in Northern Ireland.

(4) The licence holder must provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of listed NIMAR products under the licence as are necessary—

(a)to maintain the quality of the products; and

(b)to ensure their proper distribution.

(5) The licence holder must inform the licensing authority of any proposed structural alteration to, or discontinuance of use of, premises to which the licence relates or which have otherwise been approved by the licensing authority.

(6) The licence holder must not sell or supply, or offer for sale or supply, listed NIMAR products to a person in Northern Ireland, unless—

(a)there is a UKMA(UK) or UKMA(GB) in force in relation to that product; and

(b)the sale or supply is in accordance with that authorisation (except for the fact the product will be in Northern Ireland).

(7) The licence holder must—

(a)keep documents relating to the sale or supply of listed NIMAR products under the licence which may facilitate the withdrawal or recall from sale of such products in accordance with paragraph (b);

(b)maintain an emergency plan to ensure effective implementation of the recall from the market of a listed NIMAR product where recall is—

(i)ordered by the licensing authority or

(ii)carried out in co-operation with the manufacturer of, or the holder of the corresponding UKMA(GB) or UKMA(UK) for the product; and

(c)keep records in relation to the receipt, dispatch or brokering of listed NIMAR products, of—

(i)the date of receipt,

(ii)the date of despatch,

(iii)the date of brokering,

(iv)the name of the listed NIMAR product,

(v)the quantity of the product received, dispatched or brokered,

(vi)the name and address of the person from whom the products were received or to whom they are dispatched; and

(d)provide the records in sub-paragraph (c) to the licensing authority on request.

(8) For the purposes of enabling the licensing authority to determine whether there are grounds for suspending, revoking or varying the licence, the licence holder must permit a person authorised in writing by the licensing authority, on production of identification, to carry out any inspection, or to take any samples or copies, which an inspector could carry out or take under Part 16 (enforcement).

(9) The licence holder must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities.

(10) The licence holder must immediately inform the licensing authority of medicinal products which the licence holder receives or is offered which the licence holder—

(a)knows or suspects; or

(b)has reasonable grounds for knowing or suspecting,

to be falsified.

(11) Where the listed NIMAR product is obtained through brokering, a licence holder must verify that the broker involved fulfils the requirements set out in regulation 45A(1)(b).]

Textual Amendments

Requirement for wholesale dealers to decommission the unique identifierU.K.

F27843A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F279Requirement for wholesale dealers to deal only with specified personsU.K.

44.—F280(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) [F281The] licence holder must not obtain supplies of medicinal products from anyone except—

(a)the holder of a manufacturer’s licence or wholesale dealer’s licence in relation to products of that description;

(b)the person who holds an authorisation granted by [F282an approved country for import (in the case of a licence holder in Great Britain) or by an EEA State (in the case of a licence holder in Northern Ireland)] authorising the manufacture of products of the description or their distribution by way of wholesale dealing; [F283or]

[F284(c)where the medicinal product is directly received—

(i)in the case of a licence holder in Great Britain, from a country that is not an approved country for import (“A”), for export to a country that is not an approved country for import (“B”), and

(ii)in the case of a licence holder in Northern Ireland, from a country other than an EEA State (“A”) for export to another country other than an EEA State (“B”),

the supplier of the medicinal product in country A is a person who is authorised or entitled to supply such medicinal products in accordance with the legal and administrative provisions in country A.]

F285(d). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) Where a medicinal product is obtained in accordance with paragraph F286... (2)(a) or (b), the licence holder must verify that—

(a)the wholesale dealer who supplies the product complies with the principles and guidelines of good distribution practices; or

(b)the manufacturer or importer who supplies the product holds a manufacturing authorisation.

F287(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) [F288The] licence holder may distribute medicinal products by way of wholesale dealing only to—

(a)the holder of a wholesale dealer’s licence relating to those products;

[F289(b)the holder of an authorisation granted by—

(i)in the case of a licence holder in Great Britain, the appropriate authority of an approved country for import;

(ii)in the case of a licence holder in Northern Ireland, the competent authority of an EEA State,

that is responsible for authorising the supply of those products by way of wholesale dealing;]

(c)a person who may lawfully sell those products by retail or may lawfully supply them in circumstances corresponding to retail sale;

(d)a person who may lawfully administer those products; or

[F290(e)in relation to supply—

(i)in the case of a licence holder in Great Britain to persons in countries other than approved countries for import, a person who is authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the country to which the product is supplied;

(ii)in the case of a licence holder in Northern Ireland to persons in a country other than an EEA State, a person who is authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the country other than an EEA State concerned.]

(6) Where a medicinal product is supplied to a person who is authorised or entitled to supply medicinal products to the public in accordance with paragraph F291... (5)(c) or (e), the licence holder must enclose with the product a document stating the—

(a)date on which the supply took place;

(b)name and pharmaceutical form of the product supplied;

(c)quantity of product supplied; [F292and]

(d)name and address of the licence holder[F293.]

F294(e). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7) The licence holder must—

(a)keep a record of information supplied in accordance with paragraph (6) for at least five years beginning immediately after the date on which the information is supplied; and

(b)ensure that the record is available to the licensing authority for inspection.]

[F295(8) A licence holder in Great Britain may only obtain a medicinal product in respect of which a [F296UKMA(UK)(Category 2)] was granted under the unfettered access route if the product satisfies the definition of qualifying Northern Ireland goods.

(9) Paragraph (2)(c) does not apply to—

(a)in the case of a licence holder in Great Britain, products received from Northern Ireland, and

(b)in the case of a licence holder in Northern Ireland, products received from Great Britain.

(10) Paragraph (5)(e) does not apply to—

(a)in the case of a licence holder in Great Britain, products supplied to Northern Ireland, and

(b)in the case of a licence holder in Northern Ireland, products supplied to Great Britain.]

Textual Amendments

F280Reg. 44(1) omitted (E.W.S.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 6(2) and reg. 44(1) omitted (N.I.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 6(2)

F281Word in reg. 44(2) substituted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 6(3)(a) and word in reg. 44(2) substituted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 6(3)(a)

F285Reg. 44(2)(d) omitted (E.W.S.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 6(3)(d) and reg. 44(2)(d) omitted (N.I.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 6(3)(d)

F286Word in reg. 44(3) omitted (E.W.S.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 6(4) and word in reg. 44(3) omitted (N.I.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 6(4)

F287Reg. 44(4) omitted (E.W.S.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 6(5) and reg. 44(4) omitted (N.I.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 6(5)

F288Word in reg. 44(5) substituted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 6(6) and word in reg. 44(5) substituted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 6(6)

F291Word in reg. 44(6) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 7 and word in reg. 44(6) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 7

Requirement as to responsible personsU.K.

45.—(1) The licence holder must ensure that there is available at all times at least one person (referred to in this regulation as the “responsible person”) who in the opinion of the licensing authority—

(a)has knowledge of the activities to be carried out and of the procedures to be performed under the licence which is adequate to carry out the functions mentioned in paragraph (2); and

(b)has adequate experience relating to those activities and procedures.

[F297(1A) In respect of a licence holder in Great Britain, paragraph (1) is subject to regulation 45AA.]

(2) Those functions are—

(a)ensuring that the conditions under which the licence was granted have been, and are being, complied with; and

[F298(b)ensuring that the quality of medicinal products handled by the licence holder is being maintained in accordance with the requirements of—

(i)in the case of a licence holder in Great Britain, the UK marketing authorisations, certificates of registration or traditional herbal registrations, and

(ii)in the case of a licence holder in Northern Ireland, the marketing authorisations, [F299requirements of regulation 167A,] Article 126a authorisations, certificates of registration or traditional herbal registrations,

applicable to those products.]

(3) The licence holder must notify the licensing authority of—

(a)any change to the responsible person; and

(b)the name, address, qualifications and experience of the responsible person.

(4) The licence holder must not permit any person to act as a responsible person other than the person named in the licence or another person notified to the licensing authority under paragraph (3).

(5) Paragraph (6) applies if, after giving the licence holder and a person acting as a responsible person the opportunity to make representations (orally or in writing), the licensing authority thinks that the person—

(a)does not satisfy the requirements of paragraph (1) in relation to qualifications or experience; or

(b)is failing to carry out the functions referred to in paragraph (2) adequately or at all.

(6) Where this paragraph applies, the licensing authority must notify the licence holder in writing that the person is not permitted to act as a responsible person.

Textual Amendments

[F300Requirement as to responsible persons where licence holder imports from an approved country for importU.K.

45AA.—(1) Subject to paragraph (2), this regulation applies to a licence holder in Great Britain where the licence holder imports a medicinal product from an approved country for import under a wholesale dealer's licence.

(2) The requirements of this regulation do not apply where an unlicensed medicinal product falling under paragraph (1) is imported—

(a)from an approved country for import for the sole purpose of distribution by way of wholesale dealing as a special medicinal product; or

(b)for the sole purpose of wholesale distribution of that product to a person in a country other than an approved country for import.

(3) The licence holder must ensure that there is available at all times at least one person (referred to in this regulation as the “responsible person (import)”) whose name is included in the register established under regulation 45AB.

(4) A responsible person (import) must—

(a)carry out the functions under regulation 45(2), unless a responsible person under regulation 45 is performing those functions in respect of the licence; ...

(b)ensure that there is appropriate evidence to confirm that each production batch of a medicine imported from an approved country for import under the licence has been certified as provided for in Article 51 of the 2001 Directive, or such equivalent certification procedure as applies in the approved country for import; and

(c)ensure that each production batch of a medicinal product that is subject to the batch testing condition and that is imported into Great Britain from an approved country for import has been certified as being in conformity with the approved specifications in the UK marketing authorisation by—

(i)the appropriate authority, or

(ii)where the batch testing exemption applies, a laboratory in a country that has an agreement with the United Kingdom to the effect that the appropriate authority will recognise that certificate in place of the appropriate authority’s own examination.

(5) The licensing authority must publish guidance on the documentation that it considers to be appropriate evidence for the purposes of paragraph (4)(b).

(6) Guidance published under paragraph (5) may be taken into account by the licensing authority in determining whether it considers there has been a failure to comply with this regulation.

(7) The licence holder must apply to vary the licence if a change is proposed to the responsible person (import).

(8) The licence holder must not permit any person to act as a responsible person (import) other than the person named in the licence.

(9) Paragraph (10) applies if—

(a)the person acting as responsible person (import) in respect of the licence is no longer included in the register under 45AB;

(b)the licensing authority thinks, after giving the licence holder and a person acting as a responsible person (import) the opportunity to make representations (orally or in writing), that the responsible person (import) is failing to carry out the functions referred to in paragraph (4) adequately or at all.

(10) Where this paragraph applies the licensing authority—

(a)must notify the licence holder in writing that the person is not permitted to act as a responsible person (import) in respect of that licence; and

(b)may, subject to regulation 45AB(3)(b), remove that person's name from the register under regulation 45AB.

(11) In this regulation, “unlicensed medicinal product” means a medicinal product in respect of which—

(a)there is no marketing authorisation, within the meaning of the 2001 Directive, in any EEA State in respect of that product, where the product is imported from an approved country for import that is an EEA State; or

(b)there is no licence or authorisation in respect of that product as regards its sale or supply in the approved country for import, where the product is imported from an approved country for import that is not an EEA State.

Textual Amendments

Register for responsible persons (import)U.K.

45AB.—(1) The licensing authority must maintain a register of persons (“the responsible person (import) register”) who may carry out the role of responsible person (import) under regulation 45AA.

(2) The licensing authority may only include a person's name in the responsible person (import) register if that person—

(a)holds—

(i)a diploma, certificate or other evidence of formal qualifications awarded on completion of a university or other higher education course of study in pharmacy, chemistry, medicine, biology or a related life science, or

(ii)such other qualification as the licensing authority is satisfied is equivalent;

(b)is a member of—

(i)the Royal Society of Biology,

(ii)the Royal Pharmaceutical Society,

(iii)the Pharmaceutical Society of Northern Ireland,

(iv)the Royal Society of Chemistry, or

(v)such other body as may be specified by the licensing authority for the purpose of this paragraph; and

(c)has a minimum of 2 years' experience in performing the functions of a responsible person under regulation 45, or in performing such other functions that appear to the licensing authority to be equivalent.

(3) The licensing authority—

(a)may remove a person's name from the responsible person (import) register if it no longer considers that the person satisfies the requirements of paragraph (2); but

(b)it may not exercise that power unless it has given that person the opportunity to make representations to it (orally or in writing).]

Textual Amendments

[F301CHAPTER 3U.K.Brokering

Textual Amendments

Brokering in medicinal productsU.K.

45A.—[F302(1) A person may not broker a medicinal product in Great Britain unless—

(a)the product is covered by an authorisation granted—

(i)by the licensing authority, or

(ii)by an appropriate authority responsible for the licensing of medicinal products in an approved country for import, and

(b)that person—

(i)is validly registered as a broker with the licensing authority,

(ii)has a permanent address in the United Kingdom, and

(iii)complies with the guidelines on good distribution practice which apply under, or by virtue of, regulation C17 insofar as those guidelines apply to brokers.

(1A) A person may not broker a medicinal product in Northern Ireland unless—

(a)the product is covered by an authorisation granted—

F303(i). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(ii)by the licensing authority, or

(iii)by a competent authority of a member State, and

(b)that person—

(i)is validly registered as a broker with the licensing authority or a competent authority of a member State,

(ii)except where the person is validly registered with the competent authority of an EEA State, has a permanent address in the United Kingdom, and

(iii)complies with the guidelines on good distribution practice published by the European Commission in accordance with Article 84 of the 2001 Directive insofar as those guidelines apply to brokers.]

(2) A person is not validly registered for the purpose of paragraph (1)(b) [F304or (1A)(b)] if—

(a)the person’s permanent address is not entered into a register of brokers kept by a competent authority of a member State [F305or the licensing authority (as appropriate)];

(b)the registration is suspended; or

(c)the person has notified the competent authority of a member State [F306or the licensing authority (as appropriate)] to remove that person from the register.

F307(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F302Reg. 45A(1)(1A) substituted for reg. 45A(1) (31.12.2020) by S.I. 2019/775, regs. 1, 38(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 28(a))

Application for brokering registrationU.K.

45B.—(1) The licensing authority may not register a person as a broker unless paragraphs [F308(2)] to (7) are complied with.

(2) An application for registration must be made containing—

(a)the name of the person to be registered;

(b)the name under which that person is trading (if different to the name of that person);

(c)that person’s—

(i)permanent address in the United Kingdom,

(ii)e-mail address, and

(iii)telephone number;

(d)a statement of whether the medicinal products to be brokered are—

(i)prescription only medicines,

(ii)pharmacy medicines, or

(iii)medicines subject to general sale;

(e)an indication of the range of medicinal products to be brokered;

(f)evidence that that person can comply with regulations 45A(1)(b)(iii), 45E(3)(a) to (f) and 45F(1); and

(g)any fee payable in connection with the application in accordance with the Fees Regulations.

(3) Where the address at which the emergency plan, documents or record necessary to comply with regulation 45E(3)(b) to (d) are kept is different from the address notified in accordance with sub-paragraph (2)(c)(i), the application must contain—

(a)that address where the plan or records are to be kept;

(b)the name of a person who can provide access to that address for the purpose of regulation 325 (rights of entry); and

(c)that person’s—

(i)address,

(ii)e-mail address, and

(iii)telephone number.

(4) Unless paragraph (6) applies, the application for registration must—

(a)be in English; and

(b)be signed by the person seeking a brokering registration.

(5) The pages of the application must be serially numbered.

(6) Where the application is made on behalf of the person seeking a brokering registration by another person (“A”), the application must—

(a)contain the name and address of A; and

(b)be signed by A.

Textual Amendments

F308Word in reg. 45B(1) inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 4 and word in reg. 45B(1) inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 4

Procedure for determining an application for broker’s registrationU.K.

45C.—(1) The licensing authority must grant or refuse an application for registration under regulation 45B within the period of 90 days beginning immediately after the day on which it receives the application.

(2) Paragraph (1) applies to an application only if the requirements of regulation 45B(2) have been met.

(3) Before determining an application for a brokering registration, the licensing authority may notify the applicant of a requirement to provide such information as the licensing authority thinks necessary, within the period specified by the licensing authority.

(4) If a notice under paragraph (3) requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (1).

(5) In paragraph (4), the “information period” means the period—

(a)beginning with the day on which the notice is given, and

(b)ending with the day on which the licensing authority receives the information or the applicant shows to the licensing authority’s satisfaction that the applicant is unable to provide it.

Grant or refusal of broker’s registrationU.K.

45D.—(1) Subject to regulations 45E and 45F, on an application to the licensing authority for a brokering registration, the licensing authority must, if it considers it necessary and appropriate to do so—

(a)register the applicant as a broker; or

(b)refuse registration as a broker, having regard to—

(i)the provisions of these Regulations, F309...

F309(ii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) The licensing authority must give the applicant a notice stating the reasons for its decision in any case where the licensing authority—

(a)refuses to grant an application for registration; or

(b)grants registration otherwise than in accordance with the application and the applicant requests a statement of its reasons.

(3) The licensing authority must register the applicant or refuse registration under this Chapter within the period of 90 days beginning immediately after the day on which it receives the application.

(4) Where the licensing authority registers a person as a broker, the licensing authority must enter the following information into a publicly available register—

(a)the person’s name;

(b)the name under which that person is trading (if different from the person’s name);

(c)the person’s permanent address in the United Kingdom.

(5) The licensing authority must make the register of brokers publicly available.

Textual Amendments

Criteria of broker’s registrationU.K.

45E.—(1) Registration of a broker is conditional on that broker—

(a)complying with regulation 45A(1); and

(b)satisfying—

(i)the criteria in paragraphs (3), (4) and (7), and

(ii)such other criteria as the licensing authority considers appropriate and notifies the broker of.

(2) The criteria referred to in paragraph (1)(b)(ii) may include (but are not limited to) the criteria specified in paragraphs (5) and (6).

(3) The broker must—

(a)have a permanent address in the United Kingdom;

(b)maintain an emergency plan to ensure effective implementation of the recall from the market of a medicinal product where recall is—

[F310(i)ordered by—

(aa)in the case of a broker in Great Britain, the licensing authority or by an appropriate authority responsible for the licensing of medicinal products in an approved country for import, or

(bb)in the case of a broker in Northern Ireland, the licensing authority or by the competent authority of any EEA State, or]

(ii)carried out in co-operation with the manufacturer of, or the holder of the marketing authorisation, for the product;

(c)keep documents relating to the sale or supply of medicinal products under the licence which may facilitate the withdrawal or recall from sale of medicinal products in accordance with sub-paragraph (b);

(d)record in relation to the brokering of each medicinal product—

(i)the name of the medicinal product,

(ii)the quantity of the product brokered,

F311(iii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iv)the name and address of the—

(aa)supplier, or

(bb)consignee, and

(v)the date on which the sale or purchase of the product is brokered;

(e)maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities; and

(f)keep the documents or record required by sub-paragraph (c) or (d) available to the licensing authority for a period of five years; and

(g)comply with regulation 45F(1), (2) and (4).

(4) Where the address at which the plan or records necessary to comply with paragraph (3)(b) to (d) are kept is different from the address notified in accordance with regulation 45B(2)(c)(i), the broker must—

(a)ensure that the plan or records are kept at an address in the United Kingdom; and

(b)inform the licensing authority of the address at which the plan or records are kept.

(5) The broker must provide such information as may be requested by the licensing authority concerning the type and quantity of medicinal products brokered within the period specified by the licensing authority.

(6) The broker must take all reasonable precautions and exercise all due diligence to ensure that any information provided by that broker to the licensing authority in accordance with regulation 45F is not false or misleading.

(7) For the purposes of enabling the licensing authority to determine whether there are grounds for suspending, revoking or varying the registration, the broker must permit a person authorised in writing by the licensing authority, on production of identification, to carry out any inspection, or to take any copies, which an inspector may carry out or take under regulations 325 (rights of entry) and 327 (powers of inspection, sampling and seizure).

Textual Amendments

Provision of informationU.K.

45F.—(1) A broker registered in the UK must immediately inform—

(a)the licensing authority; and

[F312(b)the UK marketing authorisation holder, or, where applicable—

(i)the holder of the licence or authorisation granted by an appropriate authority responsible for the licensing of medicinal products in an approved country for import, or

(ii)the EU marketing authorisation holder,]

of medicinal products which the broker identifies as, suspects to be, or has reasonable grounds for knowing or suspecting to be, falsified.

(2) On or before the date specified in paragraph (3), a broker who is, or has applied to the licensing authority to become, a registered broker in the United Kingdom must submit a report to the licensing authority, which—

(a)includes a declaration that the broker has in place an appropriate system to ensure compliance with regulations 45A, 45B and this regulation; and

(b)details the system which the broker has in place to ensure such compliance.

(3) The date specified for the purposes of this paragraph is—

(a)in relation to any application made before 31st March 2014, the date of the application; and

(b)in relation to each subsequent reporting year, 30th April following the end of that year.

(4) The broker must without delay notify the licensing authority of any changes to the matters in respect of which evidence has been supplied in relation to paragraph (2) which might affect compliance with the requirements of this Chapter.

(5) Any report or notification to the licensing authority under paragraph (2) or (4) must be accompanied by the appropriate fee in accordance with the Fees Regulations.

(6) The licensing authority may give a notice to a registered broker requiring that broker to provide information of a kind specified in the notice within the period specified in the notice.

(7) A notice under paragraph (6) may not be given to a registered broker unless it appears to the licensing authority that it is necessary for the licensing authority to consider whether the registration should be varied, suspended or revoked.

(8) A notice under paragraph (6) may specify information which the licensing authority thinks necessary for considering whether the registration should be varied, suspended or revoked.

(9) In paragraph (3)(b), “reporting year” means a period of twelve months ending on 31st March.

Textual Amendments

Power to suspend or vary a broker’s registration or remove a broker from the registerU.K.

45G.—(1) The licensing authority may in accordance with regulation 45H—

(a)suspend a broker’s registration for such period as the authority thinks fit;

(b)vary a broker’s registration; or

(c)remove a person from the register.

(2) The suspension of registration or removal from the register may be—

(a)total;

(b)limited to medicinal products of one or more descriptions; or

(c)limited to medicinal products manufactured, assembled or stored on specified premises or a specified part of any premises.

(3) The powers conferred by this regulation may not be exercised in relation to a broker’s registration except on one or more of the following grounds—

(a)the information in the application as a result of which the broker’s registration was granted was false or incomplete in a material respect;

(b)a material change of circumstances has occurred in relation to any of the matters stated in the application;

(c)the broker has materially contravened a criterion of registration; or

(d)the broker has without reasonable excuse failed to supply information to the licensing authority with respect to medicinal products of a description to which the registration relates when required to do so under regulation 45F(6).

Procedure where licensing authority proposes to suspend or vary a broker’s registration or remove a broker from the registerU.K.

45H.—(1) This regulation applies where—

(a)regulation 45I does not apply; and

(b)the licensing authority proposes to exercise the power in regulation 45G(1).

(2) The licensing authority must notify the broker in writing of—

(a)its proposal;

(b)the reasons for it; and

(c)the date (which must be no earlier than 28 days from the notice given by the licensing authority) on which it is proposed that the suspension, variation or revocation should take effect.

(3) The registered broker may before the date specified in the notice—

(a)make written representations to the licensing authority with respect to the proposal; or

(b)notify the licensing authority that the broker wishes the licensing authority to submit the proposal to review upon oral representations.

(4) If the broker makes written representations in accordance with paragraph (3)(a) the licensing authority must take those representations into account before making a decision in the matter.

(5) Schedule 5 has effect if the registered broker—

(a)notifies the licensing authority of the proposal to review upon oral representations in accordance with paragraph (3)(b); and

(b)pays the fee for a review upon oral representations in accordance with the Fees Regulations.

(6) If the licensing authority proceeds to suspend or vary a registration or remove a broker from the register in accordance with the provisions of regulation 45G it must give a notice to the broker.

(7) A notice under paragraph (6) must—

(a)give particulars of the suspension, variation or removal; and

(b)give reasons for the decision to suspend, vary or remove a broker from the register.

(8) Paragraphs (6) and (7) are without prejudice to any requirement of Schedule 5 as to notification.

Suspension of a broker registration in cases of urgencyU.K.

45I.—(1) The licensing authority may immediately suspend a broker’s registration for a period not exceeding three months where it appears to the licensing authority that in the interests of safety it is appropriate to do so.

(2) This paragraph applies where—

(a)a broker’s registration has been suspended under paragraph (1); and

(b)it appears to the licensing authority that it is necessary to consider whether the broker’s registration should be—

(i)further suspended or varied, or

(ii)removed from the brokers’ register.

(3) Where paragraph (2) applies, the licensing authority must proceed as set out in regulation 45H (but this is subject to paragraph (4)).

(4) Paragraph (5) applies where, in circumstances where paragraph (2) applies, the licensing authority proceeds as set out in regulation 45H and any proceedings under that regulation have not been finally disposed of before the end of the period for which the registration was suspended under paragraph (1) or further suspended under paragraph (5).

(5) If it appears to the licensing authority to be necessary in the interests of safety to do so, the authority may further suspend the registration for a period which (in the case of each further suspension) is not to exceed three months.

(6) In the event that any challenge against a decision under regulation 45H to suspend, vary or revoke the registration is made on an application under regulation 322(4), paragraph (5) shall apply, but this is without prejudice to regulation 322(6)(a) (validity of decisions and proceedings).

Variation of a broker’s registration on the application of the brokerU.K.

45J.—(1) This regulation applies if the person registered as a broker applies to the licensing authority for a variation of the registration.

(2) The application must—

(a)be in writing;

(b)specify the variation requested;

(c)be signed by or on behalf of the applicant;

(d)be accompanied by such information as may be required to enable the licensing authority to consider the application;

(e)include the appropriate fee in accordance with the Fees Regulations.

(3) The licensing authority must vary a broker’s registration or refuse to vary it within 30 days beginning with the day after the date when the licensing authority receives the application.

(4) The licensing authority may give a notice to the applicant requiring the applicant to supply further information in connection with the application within the period specified in the notice.

(5) If a notice under paragraph (4) requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (3).

(6) In paragraph (5), the “information period” means the period—

(a)beginning with the day on which notice is given; and

(b)ending with the day on which the licensing authority receives the information or the applicant shows to the licensing authority’s satisfaction that the applicant is unable to provide it.

(7) Nothing in this regulation affects the powers conferred by regulations 45G and 45I.

Offences: breach of regulations and false informationU.K.

45K.—(1) A person is guilty of an offence if the person—

(a)contravenes regulation 45A(1); or

(b)brokers a medicinal product otherwise than in accordance with the criteria under regulation 45E relating to that person’s brokering registration.

(2) A person is guilty of an offence if the person knowingly gives false information in—

(a)an application for a broker registration under regulation 45B(2);

(b)a notification to the licensing authority under regulation 45F(4);

(c)an application for a variation under regulation 45J(1); or

(d)response to a notice under regulation 45C(3) or 45J(5).

(3) A person is guilty of an offence if, without reasonable excuse, the person fails to comply with a notice under regulation 45F(6) or 45J(5).

PenaltiesU.K.

45L.—(1) A person guilty of an offence under regulation 45K(1) or (2) is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment to a fine, to imprisonment for a term not exceeding two years, or to both.

(2) A person guilty of an offence under regulation 45K(3) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.]

[F301CHAPTER 4U.K.Importation, manufacture and distribution of active substances

Criteria for importation, manufacture or distribution of active substancesU.K.

45M.—(1) A person may not—

(a)import;

(b)manufacture; or

(c)distribute,

an active substance unless that person is registered with the licensing authority in accordance with regulation 45N and the requirements in regulation 45O are met.

(2) Paragraph (1) applies in relation to an active substance which is to be used in an investigational medicinal product only—

[F313(a)if—

(i)in the case of a product for sale or supply in Great Britain, the product has a UK marketing authorisation, certificate of registration or traditional herbal registration, or

(ii)in the case of a product for sale or supply in Northern Ireland, the product has a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration, and]

(b)to the extent that the manufacture of the active substance is in accordance with the terms and conditions of that authorisation, certificate or registration.

(3) Paragraph (1)(a) does not apply to a person who, in connection with the importation of an active substance F314...—

(a)provides facilities solely for transporting the active substance; or

(b)acting as an import agent, imports the active substance solely to the order of another person who holds a certificate of good manufacturing practice issued by the licensing authority.

Textual Amendments

Registration in relation to active substancesU.K.

45N.—(1) For registration in relation to active substances, the licensing authority must have received a valid registration form from the applicant for import, manufacture or, as the case may be, distribution of an active substance and—

(a)60 days have elapsed since receipt and the licensing authority have not notified the applicant that an inspection will be carried out; or

(b)the licensing authority—

(i)notified the applicant within 60 days of receipt of a registration form that an inspection will be carried out; and

(ii)within 90 days of that inspection the licensing authority have issued that person with a certificate of good manufacturing practice or, as the case may be, of good distribution practice; and

(c)that person has not instructed the licensing authority to end that person’s registration.

(2) The person applying for registration under paragraph (1) must notify the licensing authority of any changes which have taken place as regards the information in the registration form—

(a)immediately where such changes may have an impact on quality or safety of the active substances that are manufactured, imported or distributed;

(b)in any other case, on each anniversary of the receipt of the application form by the licensing authority.

(3) For the purpose of paragraph (2), changes which are notified in accordance with that paragraph shall be treated as incorporated in the application form.

(4) Any notification to the licensing authority under paragraph (2) must be accompanied by the appropriate fee in accordance with the Fees Regulations.

(5) A registration form is valid for the purpose of paragraph (1) if—

(a)it is provided to the licensing authority; and

(b)is completed in the way and form specified in Schedule 7A.

(6) Paragraph (1) does not apply until 20th October 2013 in relation to a person who had, before 20th August 2013, commenced the activity for which the person would, apart from this provision, need to send a registration form to the licensing authority.

Requirements for registration as an importer, manufacturer or distributor of an active substanceU.K.

45O.—[F315(1) Where principles and guidelines of good manufacturing practice have been published under, or apply by virtue of, regulation C17, which apply to an active substance manufactured in Great Britain, a manufacturer in Great Britain must comply with the principles and guidelines of good manufacturing practice for active substances.

(1A) Where the Commission has adopted principles and guidelines of good manufacturing practice under the third paragraph of Article 47 of the 2001 Directive which applies to an active substance manufactured in Northern Ireland, a manufacturer in Northern Ireland must comply with the principles and guidelines of good manufacturing practice for active substances.]

[F316(2) Where principles and guidelines of good distribution practice have been published under, or apply by virtue of, regulation C17, which apply to an active substance distributed in Great Britain, a distributor in Great Britain must comply with the principles and guidelines of good distribution practice for active substances.

(2A) Where the Commission has adopted principles and guidelines of good distribution practice under the fourth paragraph of Article 47 of the 2001 Directive which applies to an active substance distributed in the Northern Ireland, a distributor in Northern Ireland must comply with the principles and guidelines of good distribution practice for active substances.]

(3) Without prejudice to regulation 37(4) (manufacture and assembly in relation to active substances) and paragraph 9A of Schedule 8 (material to accompany an application for a UK marketing authorisation in relation to an active substance), where the Commission has adopted principles and guidelines of good manufacturing practice under the third paragraph of Article 47 of the 2001 Directive which applies to an active substance imported into [F317Northern Ireland] and where an active substance is imported [F318into Northern Ireland from a country other than an EEA State]—

(a)the importer must comply with good manufacturing practice and good distribution practice in relation to the active substance;

(b)the active substances must have been manufactured in accordance with standards which are at least equivalent to good manufacturing practice; and

(c)the active substances must be accompanied by a written confirmation from the competent authority of the [F319exporting country] of the following—

(i)the standards of manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to good manufacturing practice,

(ii)the manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of standards of manufacturing practice at least equivalent to good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in [F320Northern Ireland], and

(iii)in the event of findings relating to non-compliance, information on such findings is supplied by the [F319exporting country] to the Union without any delay.

[F321(3A) Without prejudice to regulation 37(4) and paragraph 9A of Schedule 8, where principles and guidelines of good manufacturing practice have been published under, or apply by virtue of, regulation C17, which apply to an active substance imported into Great Britain other than from Northern Ireland and where an active substance is so imported—

(a)the importer must comply with good manufacturing practice and good distribution practice in relation to the active substance,

(b)the active substances must have been manufactured in accordance with standards which are at least equivalent to good manufacturing practice, and

(c)the active substances must be accompanied by a written confirmation from the competent authority of the exporting country of the following—

(i)the standards of manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to good manufacturing practice,

(ii)the manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of standards of manufacturing practice at least equivalent to good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in Great Britain, and

(iii)in the event of findings relating to non-compliance, information on such findings is supplied by the exporting country to the licensing authority without any delay.]

(4) Paragraph [F322(3)(c) and (3A)(c) do] not apply—

(a)where the country from where the active substance is exported is included in the list referred to in Article 111b of the 2001 Directive [F323(in the case of an import into Northern Ireland) or paragraph (6) (in the case of an import into Great Britain)]; or

(b)for a period not exceeding the validity of the certificate of good manufacturing practice, where—

(i)in relation to a plant where active substances are manufactured where the competent authority of a member State [F324or licensing authority (in the case of an import into Northern Ireland) or licensing authority or an appropriate authority responsible for the licensing of medicinal products in a country included in a list under paragraph (6) (in the case of an import into Great Britain)] has found, upon inspection, that a plant complies with the principles and guidelines of good manufacturing practice, and

(ii)the licensing authority is of the opinion that it is necessary to waive the requirement to ensure availability of the active substance.

(5) The criteria in this regulation apply regardless of whether an active substance is intended for export.

[F325(6) The licensing authority may publish a list of countries which it is satisfied have a regulatory framework applicable to active substances exported to Great Britain that is equivalent to the regulatory framework in Great Britain, in that the respective control and enforcement activities in those countries ensures an equivalent level of protection of public health.

(7) Before including a country in the list under paragraph (6), the licensing authority must assess the equivalence referred to in that paragraph by—

(a)reviewing relevant documentation; and

(b)unless the country is included in the approved country for batch testing list, carrying out—

(i)an on-site review of the country's regulatory system, and

(ii)if the licensing authority considers it necessary, an inspection of one or more of that country's manufacturing sites for active substances.

(8) In carrying out an assessment under paragraph (7) the licensing authority must in particular take account of the—

(a)country's rules for good manufacturing practice;

(b)regularity of inspections to verify compliance with good manufacturing practice;

(c)effectiveness of enforcement of good manufacturing practice; and

(d)regularity and rapidity of information provided by that country relating to non-compliant producers of active substances.

(9) The licensing authority must—

(a)review the list under paragraph (6) to determine if a country included in it still satisfies the requirements for inclusion in the list, and if it is not so satisfied, remove that country; and

(b)undertake such a review at least every three years, beginning with the date on which a country is included in the list .]

Textual Amendments

Provision of informationU.K.

45P.—(1) In this regulation—

“R” means a person who is, or has applied to the licensing authority to become, a registered importer, manufacturer or distributor of active substances;

“reporting year” means a period of twelve months ending on 31st March.

(2) On or before the date specified in paragraph (3), R must submit a report to the licensing authority which—

(a)includes a declaration that R has in place an appropriate system to ensure compliance with regulations 45N, 45O and this regulation; and

(b)details the system which R has in place to ensure such compliance.

(3) The date specified for the purposes of this paragraph is—

(a)in relation to any application made before 31st March 2014, the date of the application; and

(b)in relation to each subsequent reporting year, 30th April following the end of that year.

(4) R must without delay notify the licensing authority of any changes to the matters in respect of which evidence has been supplied in relation to paragraph (2) which might affect compliance with the requirements of this Chapter.

(5) Any report or notification to the licensing authority under paragraph (2) or (4) must be accompanied by the appropriate fee in accordance with the Fees Regulations.

(6) The licensing authority may give a notice to R, requiring R to provide information of a kind specified in the notice within the period specified in the notice.

(7) A notice under paragraph (6) may not be given to R unless it appears to the licensing authority that it is necessary for the licensing authority to consider whether the registration should be varied, suspended or removed from the active substance register.

(8) A notice under paragraph (6) may specify information which the licensing authority thinks necessary for considering whether the registration should be varied, suspended or removed from the active substance register.

Power to suspend or vary or remove an active substance registrationU.K.

45Q.—(1) The licensing authority may in accordance with regulation 45R—

(a)suspend an active substance registration for such period as the authority thinks fit;

(b)vary an active substance registration; or

(c)remove a person from the active substance register.

(2) The suspension of registration may be—

(a)total;

(b)limited to active substances of one or more descriptions; or

(c)limited to active substances imported, manufactured, assembled or stored on specified premises or a specified part of any premises.

(3) The powers conferred by this regulation may not be exercised in relation to an active substance registration except on one or more of the following grounds—

(a)the information in the application as a result of which the active substance registration was granted was false or incomplete in a material respect;

(b)a material change of circumstances has occurred in relation to any of the matters stated in the application;

(c)the person with an active substance registration has materially contravened a criterion of registration; or

(d)the person with an active substance registration has without reasonable excuse failed to supply information to the licensing authority with respect to active substances of a description to which the registration relates when required to do so under regulation 45P(6).

Procedure where licensing authority proposes to suspend or vary an active substance registration or remove a person from the active substance registerU.K.

45R.—(1) This regulation applies where—

(a)the provisions of regulation 45S do not apply; and

(b)the licensing authority proposes to exercise the power in regulation 45Q(1).

(2) The licensing authority must notify the person with an active substance registration in writing of—

(a)its proposal;

(b)the reasons for it; and

(c)the date (which must be no earlier than 28 days from the notice given by the licensing authority) on which it is proposed that the suspension, variation or removal from the active substance register should take effect.

(3) The person with an active substance registration may before the date specified in the notice—

(a)make written representations to the licensing authority with respect to the proposal; or

(b)notify the licensing authority that the person wishes the licensing authority to submit the proposal to review upon oral representations.

(4) If the person with an active substance registration makes written representations in accordance with sub-paragraph (3)(a) the licensing authority must take those representations into account before making a decision in the matter.

(5) If the person with an active substance registration notifies the licensing authority that the person wishes the licensing authority to submit the proposal to review upon oral representations in accordance with paragraph (3)(b)—

(a)Schedule 5 has effect; and

(b)the person with an active substance registration must pay a fee for a review upon oral representations in accordance with the Fees Regulations.

(6) If the licensing authority proceeds to suspend or vary a registration or remove a person from the active substance register in accordance with the provisions of regulation 45Q it must give a notice to that person.

(7) The notice must—

(a)give particulars of the suspension, variation or removal; and

(b)give reasons for the decision to suspend, vary or remove a person’s entry on the active substance register.

(8) Paragraphs (6) and (7) are without prejudice to any requirement of Schedule 5 as to notification.

Suspension of an active substance registration in cases of urgencyU.K.

45S.—(1) The licensing authority may immediately suspend a person’s active substance registration for a period not exceeding three months where it appears to the licensing authority that in the interests of safety it is appropriate to do so.

(2) This paragraph applies where—

(a)a person’s active substance registration has been suspended under paragraph (1); and

(b)it appears to the licensing authority that it is necessary to consider whether a person’s active substance registration should be—

(i)further suspended or varied, or

(ii)removed from the active substance register.

(3) Where paragraph (2) applies, the licensing authority must proceed as set out in regulation 45R (but this is subject to paragraph (4)).

(4) Paragraph (5) applies where, in circumstances where paragraph (2) applies, the licensing authority proceeds as set out in regulation 45R and any proceedings under that regulation have not been finally disposed of before the end of the period for which the registration was suspended under paragraph (1) or further suspended under paragraph (5).

(5) If it appears to the licensing authority to be necessary in the interests of safety to do so, the authority may further suspend the registration for a period which (in the case of each further suspension) is not to exceed three months.

(6) In the event that any challenge against a decision under regulation 45R to suspend, vary or remove a person’s active substance registration is made on an application to the High Court under regulation 322(4), paragraph (5) shall apply, but this is without prejudice to regulation 322(6)(a) (validity of decisions and proceedings).

Variation of an active substance registration on an application from the registered personU.K.

45T.—(1) This regulation applies if a person with an active substance registration applies to the licensing authority for a variation of the registration.

(2) The application must—

(a)be in writing;

(b)specify the variation requested;

(c)be signed by or on behalf of the applicant;

(d)be accompanied by such information as may be required to enable the licensing authority to consider the application; and

(e)include the appropriate fee in accordance with the Fees Regulations.

(3) The licensing authority must vary an active substance registration or refuse to vary it within 30 days beginning with the day after the date when the licensing authority receives the application.

(4) The licensing authority may give a notice to the applicant requiring the applicant to supply further information in connection with the application within the period specified in the notice.

(5) If a notice under paragraph (4) requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (3).

(6) In paragraph (5), the “information period” means the period—

(a)beginning with the day on which notice is given; and

(b)ending with the day on which the licensing authority receives the information or the applicant shows to the licensing authority’s satisfaction that the applicant is unable to provide it.

(7) Nothing in this regulation affects the powers conferred by regulations 45Q and 45S.

Offences: breach of regulations and false informationU.K.

45U.—(1) A person is guilty of an offence if the person imports, manufactures or distributes an active substance in breach of regulation 45M(1).

(2) A person is guilty of an offence if the person knowingly gives false information in—

(a)a registration form received by the licensing authority under regulation 45N(1);

(b)a notification to the licensing authority under regulation 45N(2) or 45P(4);

(c)an application for a variation under regulation 45T(2); or

(d)response to a notice under regulation 45T(4).

(3) A person is guilty of an offence if, without reasonable excuse, the person fails to comply with a notice under regulation 45P(6) or 45T(4).

PenaltiesU.K.

45V.—(1) A person guilty of an offence under regulation 45U(1) or (2) is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment to a fine, to imprisonment for a term not exceeding two years, or to both.

(2) A person guilty of an offence under regulation 45U(3) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.]

PART 4U.K.Requirement for authorisation

Requirement for authorisationU.K.

46.—(1) A person may not sell or supply, or offer to sell or supply, an unauthorised medicinal product.

(2) A person may not sell or supply, or offer to sell or supply, a medicinal product otherwise than in accordance with the terms of—

(a)a [F326UK] marketing authorisation;

F327(aa). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)a certificate of registration;

(c)a traditional herbal registration; or

(d)an Article 126a authorisation.

(3) A person may not possess an unauthorised medicinal product if the person knows or has reasonable cause to believe that the product is intended to be sold or supplied to another person within the [F328United Kingdom or the] European Economic Area.

(4) A person may not in the circumstances mentioned in paragraph (5)—

(a)manufacture or assemble a medicinal product; or

(b)procure the sale, supply, manufacture or assembly of a medicinal product.

(5) Those circumstances are that the person knows or has reasonable cause to believe that the medicinal product has been or is intended to be sold or supplied contrary to paragraph (1).

(6) For the purposes of this regulation a medicinal product is unauthorised if none of the following is in force for the product [F329in the country in which the product is intended to be sold or supplied, or offered for sale or supply]—

(a)a [F330UK] marketing authorisation;

F331(aa). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)a certificate of registration;

(c)a traditional herbal registration; or

(d)an Article 126a authorisation.

(7) This regulation is subject to—

(a)Part 10 (exceptions to requirement for marketing authorisation etc); and

(b)Article 83 of Regulation (EC) No 726/2004 (authorisation of placing on the market of medicinal product for compassionate reasons).

(8) A medicinal product is not unauthorised for the purposes of this regulation if—

(a)it is sold or supplied, or offered for sale or supply, for export to an EEA State; and

(b)the product may lawfully be sold or supplied in that state by virtue of legislation adopted by that state in compliance with the 2001 Directive.

(9) Paragraphs (1) and (2) do not apply to the sale, supply, or offer for sale or supply, of a medicinal product to a person outside the [F332United Kingdom or the] European Economic Area.

(10) Paragraphs (1) and (2) do not apply to the sale, supply, or offer for sale or supply, of an investigational medicinal product to a person specified in regulation 13(1) of the Clinical Trials Regulations for the purposes of administering that product in a clinical trial, provided that the conditions specified in regulation 13(2) of those Regulations are satisfied.

(11) Paragraph (3) does not apply to possession of an investigational medicinal product by a person who knows or has reasonable cause to believe—

(a)that the investigational medicinal product is intended to be sold or supplied within the [F333United Kingdom or the] European Economic Area; and

(b)that paragraph (10) will apply to the sale or supply.

Textual Amendments

Breach of requirementU.K.

47.—(1) A person who breaches regulation 46 is guilty of an offence.

(2) A person guilty of an offence under this regulation is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment to a fine, to imprisonment not exceeding two years or to both.

(3) It is to be presumed for the purposes of regulation 46(3) that, if a person (“P”) knows or has reasonable cause to believe that a medicinal product is intended to be sold or supplied to another person, P knows or has reasonable cause to believe that the other person is within the [F334United Kingdom or the] European Economic Area.

(4) Paragraph (3) does not apply if P proves that P did not know or have reasonable cause to believe that the person was within the [F335United Kingdom or the] European Economic Area.

(5) Where evidence is adduced that is sufficient to raise an issue with respect to the defence in paragraph (4), the court or jury must assume that the defence is satisfied unless the prosecution proves beyond reasonable doubt that it is not.

(6) Paragraph (7) applies if the holder of a marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation is charged with an offence under this regulation in respect of anything that—

(a)has been manufactured or assembled to the holder's order by another person; and

(b)has been so manufactured or assembled as not to comply with the terms of the authorisation, certificate or registration.

(7) Where this paragraph applies, it is a defence for the holder to prove that—

(a)the holder communicated the terms of the authorisation, certificate or registration to the other person; and

(b)the holder did not know and could not by the exercise of reasonable care have known that those terms had not been complied with.

Textual Amendments

PART 5U.K.Marketing authorisations

Application of this PartU.K.

48.—(1) This Part applies to relevant medicinal products.

(2) In this Part—

F336...

[F337“excluded reference product” means—

(a)

a medicinal product authorised on the basis that it was a generic medicinal product;

(b)

a medicinal product authorised on the basis that one or more of the circumstances listed in Article 10(3) of the 2001 Directive or regulation 52(1)(b) applied; or

(c)

a biological medicinal product authorised on the basis that it did not meet a condition for being a generic medicinal product for any of the reasons described in Article 10(4) of the 2001 Directive or regulation [F33853B(1)];]

[F339“generic medicinal product”, in relation to a reference medicinal product for an application for—

(a)

a UKMA(NI) or [F340UKMA(UK)(Category 2)], has the meaning given in Article 10(2)(b) of the 2001 Directive;

(b)

a [F341UKMA(UK)(Category 1)], means a medicinal product—

(i)

that has the same qualitative and quantitative composition in active substances as the reference medicinal product;

(ii)

that has the same pharmaceutical form as the reference medicinal product; and

(iii)

whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies;]

[F342“parallel import licence” means a licence that is granted by the licensing authority under this Part authorising the holder to place on the market a medicinal product imported in to the United Kingdom from an EEA State where that product—

(a)

has been granted an EU marketing authorisation or a marketing authorisation in an EEA State under the 2001 Directive; and

(b)

is essentially similar to a product that has been granted a UK marketing authorisation;]

“relevant medicinal product” means a medicinal product that is not—

(a)

a registrable homoeopathic medicinal product; or

(b)

a traditional herbal medicinal product; and

[F343“reference medicinal product” means—

(a)

in relation to an application for a UKMA(NI), a medicinal product—

(i)

authorised for sale or supply in Northern Ireland under regulation 49(1)(a), in accordance with the provisions of regulation 50; or

(ii)

in relation to which an EU marketing authorisation or a marketing authorisation granted by a member State pursuant to the 2001 Directive is or has been in force,

but which is not an excluded reference product;

(b)

F344...

(c)

in relation to an application for a UKMA(UK), a medicinal product—

(i)

authorised under regulation 49(1)(a) for sale or supply in the whole of the United Kingdom, whether by virtue of one or more UK marketing authorisations, in accordance with the provisions of regulation 50[F345, ]

(ii)

F346...

but which is not an excluded reference product;]

[F347(3) In this Part, references to a medicinal product to be imported that is “essentially similar to a product that has been granted a UK marketing authorisation” are to be read as references to a medicinal product to be imported that—

(a)has been manufactured to the same formulation as a product that has been granted a UK marketing authorisation (“the UK product”);

(b)contains the same active ingredients as the UK product;

(c)has the same therapeutic effect as the UK product,

and for the purposes of sub-paragraph (a), any differences in a product's formulation are to be ignored in so far as they are considered to be immaterial by the licensing authority.

(4) For the purposes of the definition of generic medicinal product—

(a)the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are considered to be the same active substance, unless they differ significantly in properties with regard to safety or efficacy; and

(b)the various immediate-release oral pharmaceutical forms are considered to be the same pharmaceutical form.

(5) When a medicinal product has been granted a UK marketing authorisation under regulation 49(1)(a) in accordance with the provisions of regulation 50 (“initial marketing authorisation”), any additional strengths, pharmaceutical forms, administration routes, presentations, variations and extensions in relation to which a UK marketing authorisation is granted under regulation 49(1)(a), or which are included in the initial UK marketing authorisation, belong to the same “global marketing authorisation”.

(6) Paragraph (7) applies if a medicinal product—

(a)belongs to a global marketing authorisation but is not the initial marketing authorisation; and

(b)is used as a reference medicinal product in accordance with regulations 51 to 53B.

(7) Where this paragraph applies, the medicinal product is treated for the purposes of the application of regulation [F34851B(1) and (6)] as if it had been authorised on the date of authorisation of the medicinal product to which the initial marketing authorisation relates.

F349(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F350(9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ]

Textual Amendments

Application for UK marketing authorisationU.K.

Application for grant of UK marketing authorisation [F351or parallel import licence] U.K.

49.—[F352(1) The licensing authority may grant—

(a)subject to regulation 58, [F35358C, 58E, 58F and 58G,] a UK marketing authorisation; or

(b)a parallel import licence,

for a relevant medicinal product in response to an application made in accordance with this Part.]

[F354(1ZA) If the licensing authority determines to grant a UKMA(UK) under paragraph (1), it must determine if one or more of the following criteria are met in relation to the medicinal product—

(a)it belongs to a category of medicinal product referred to in Article 3(1) of Regulation (EC) No 726/2004;

(b)it belongs to a category of medicinal product referred to in Article 3(2) of Regulation (EC) No 726/2004 and—

(i)the medicinal product contains an active substance which, on 20th May 2004, was not authorised in the European Union, or

(ii)the licensing authority considers that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that granting the marketing authorisation is in the interest of patients’ health in the United Kingdom.

(1ZB) If the licensing authority determines that one or more of the criteria in paragraph (1ZA) are met, the marketing authorisation granted is a UKMA(UK)(Category 1).

(1ZC) If the licensing authority determines that none of the criteria in paragraph (1ZA) are met, the marketing authorisation granted is a UKMA(UK)(Category 2).

(1ZD) The licensing authority may grant a UKMA(NI) under Chapter 4 of Title III of the 2001 Directive where there is an application for a marketing authorisation for a medicinal product, unless there is a UKMA(UK), or an application yet to be determined for a UKMA(UK), for the same medicinal product.]

[F355(1A) The licensing authority may accept an application meeting reduced or alternative requirements specified in this Part (“under the unfettered access route”) and grant a [F356UKMA(UK)(Category 2)] only where—

[F357(a)there is in place, or will be at the time the UKMA(UK)(Category 2) is granted, a UKMA(NI) in respect of the product authorising sale or supply in Northern Ireland,]

(b)the applicant complies with the requirements in regulation 50(1A), and

(c)the medicinal product satisfies the definition of qualifying Northern Ireland goods.

(1B) The licensing authority may only grant a parallel import licence if it is able to obtain the information necessary, whether from a competent authority of an EEA State or otherwise, to satisfy itself that the medicinal product to be imported—

(a)has been granted an EU marketing authorisation or a marketing authorisation under the 2001 Directive; and

(b)is essentially similar to a product that has already been granted a UK marketing authorisation.

(1C) A marketing authorisation or parallel import licence must state whether it is in force in—

(a)the whole United Kingdom;

(b)Great Britain only; or

(c)Northern Ireland only,

and in these Regulations the meaning of a reference to that authorisation or licence being “in force” is limited to that territory.]

(2) A marketing authorisation [F358or parallel import licence] granted under paragraph (1) shall contain terms approved by the licensing authority.

[F359(3) The applicant, where it is applying for—

[F360(a)[F361a UK marketing authorisation must, subject to sub-paragraph (b),] be established in the United Kingdom or an EEA State;]

(b)a [F362UKMA(UK)(Category 2)] —

(i)under the unfettered access route, must be established in Northern Ireland;

F363(ii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)a [F364parallel import licence], must be established in the United Kingdom.]

[F365(3ZA) Where a UKMA(UK)(Category 2) is granted under the unfettered access route, any UKMA(NI) granted in relation to the same medicinal product ceases to have effect.]

[F366(3A) An application for a parallel import licence may not be made by—

(a)the holder of the marketing authorisation, within the meaning of the 2001 Directive, or the EU marketing authorisation, in respect of the relevant medicinal product to be imported; or

(b)a company which is in the same group as the holder of that marketing authorisation.]

(4) The application must be—

(a)made in writing;

(b)signed by or on behalf of the applicant; and

(c)unless the licensing authority directs otherwise, accompanied by any fee payable in connection with the application.

(5) An application is treated as signed for the purposes of paragraph (4)(b) if it is signed with an electronic signature.

(6) The application and any accompanying material must be in English.

(7) The application must include a statement indicating whether the product to which the application relates should be available—

(a)only on prescription;

(b)only from a pharmacy; or

(c)on general sale.

(8) The application must include a statement indicating—

(a)whether any terms of the authorisation are proposed relating to the method of sale or supply of the product (including, in particular, any proposed restrictions affecting the circumstances of the use or promotion of the product); and

(b)if so, what terms are proposed.

[F367( 9) The application must include a statement indicating whether the authorisation or licence sought is for sale or supply of the product in—

(a)the whole United Kingdom;

(b)F368...; or

(c)Northern Ireland only.

(10) In this regulation “group” has the same meaning as in Part 15 of the Companies Act 2006 (see section 474(1) of that Act).]

Textual Amendments

F351Words in reg. 49 heading inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 49 heading inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(a)

F358Words in reg. 49(2) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 49(2) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(b)

Accompanying materialU.K.

50.—(1) An applicant for the grant of a UK marketing authorisation for a relevant medicinal product must provide the material specified in Schedule 8 in relation to the product.

[F369(1A) An applicant for the grant of a parallel import licence for a relevant medicinal product must provide the material specified in Schedule 8A in relation to the product.]

[F370(1A) An applicant for the grant of a UK marketing authorisation for a relevant medicinal product must provide—

(a)in the case of an application under the unfettered access route—

(i)the material specified in Schedule 8C, and

(ii)any material specified in Schedule 8 which is not included in the material specified in Schedule 8C, and

(b)in all other cases, the material specified in Schedule 8,

in relation to the product.]

(2) An applicant for the grant of a UK marketing authorisation [F371or parallel import licence] for a radionuclide generator must, in addition, provide—

(a)a general description of the system together with a detailed description of the components of the system which may affect the composition or quality of the daughter nucleid preparation; and

(b)qualitative and quantitative particulars of the eluate or the sublimate.

(3) The applicant must also, if requested by the licensing authority to do so, provide the licensing authority with material or information that the licensing authority reasonably considers necessary for dealing with the application.

[F372(3A) Paragraph (4) does not apply in respect of an application under the unfettered access route.]

[F373(4) If any of the medicinal products to which the application for a UK marketing authorisation relates—

(a)in the case of a UKMA(NI) or a [F374UKMA(UK)(Category 2)], is liable to be imported from a country other than an EEA State, or

(b)in the case of a [F375UKMA(UK)(Category 1)], is liable to be imported,

the material or information referred to in paragraph (3) may include an undertaking from the manufacturer of the product to comply with the matters set out in Schedule 9.]

(5) [F376Subject to paragraphs (5AA) and (5AB),] material that is submitted under this regulation [F377for the purposes of a UK marketing authorisation] must be submitted in accordance with the applicable provisions of Annex I to the 2001 Directive.

[F378(5AA) In addition to the information referred to in Part 1, paragraph 1.2, fourth paragraph of Annex 1 to the 2001 Directive, an applicant for the grant of a UK marketing authorisation for an MM medicinal product must also provide a copy of the MM master file for that product.

(5AB) In addition to the information referred to in Part 1, paragraph 1.2, fourth paragraph of Annex 1 to the Directive, an applicant for the grant of a UK marketing authorisation for a POC medicinal product must also provide a copy of the POC master file for that product.]

[F379(5A) The Secretary of State may by regulationsF380... amend Schedule 8B (modifications of Annex I) in relation to a [F381UKMA(UK)(Category 1)] for the purpose of further modifying Annex I to the 2001 Directive in order to take account of scientific and technical progress.

(5B) The licensing authority may publish, for the purposes of applications made pursuant to this regulation—

(a)guidance on the presentation and content of the material specified in Schedule 8;

(b)scientific guidelines relating to the quality, safety and efficacy of medicinal products; and

(c)guidelines describing the active substance manufacturing process and process controls.

(5C) Unless replaced by guidance or guidelines published under the power conferred by paragraph (5B), the following guidance and guidelines continue to apply as they applied immediately before IP completion day (subject to any amendments or variations published under that paragraph)—

(a)the guidance published by the European Commission in the rules governing medicinal products in the European Community, Volume 2B, Notice to Applicants, Medicinal Products for human use, Presentation and content of the dossier, Common Technical Document;

(b)the scientific guidelines relating to the quality, safety and efficacy of medicinal products as adopted by the Committee for Medicinal Products for Human Use and published by the EMA and the other pharmaceutical Community guidelines published by the European Commission in the different volumes of the rules governing medicinal products in the European Community; and

(c)guidelines published by the EMA for the purposes of paragraph 3.2.1.2 of Part I of Annex I to the 2001 Directive.]

(6) [F382Unless the application is for a parallel import licence this] regulation is subject to—

[F383(za)regulation 50A (requirement for certain applications to include results of paediatric investigation plan);

(zb)regulation 50E (application for paediatric use marketing authorisation);

(zc)regulation 50F (other applications including paediatric indications);

(zd)regulation 50G (applications relating to orphan medicinal products);

(ze)regulation 50H (applications relating to advanced therapy medicinal products);

(zf)regulation 50I (applications relating to conditional marketing authorisations);

(zg)regulation 50J (applications relating to medicinal products containing or consisting of genetically modified organisms);]

[F384(a)regulation 51 (application for UKMA(NI) relating to generic medicinal products);

F385(aa). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(ab)regulation 51B (application for UKMA(UK) relating to generic medicinal products);]

[F386(b)regulation 52 (application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etc);

F387(ba). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(bb)regulation 52B (application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc);]

[F388(c)regulation 53 (application for UKMA(NI) relating to similar biological medicinal products);

F389(ca). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(cb)regulation 53B (application for UKMA(UK) relating to similar biological medicinal products);]

(d)regulation 54 (applications relating to products in well-established medicinal use);

(e)regulation 55 (applications relating to new combinations of active substances);

(f)regulation 56 (applications containing information supplied in relation to another medicinal product with consent); and

(g)Schedule 10 (applications relating to national homoeopathic products).

[F390(7) The licensing authority may make appropriate arrangements with any EEA State or the EMA in order to obtain the information it considers necessary to satisfy itself that a product to be imported under a parallel import licence is essentially similar to a product that has been granted a UK marketing authorisation.

(8) If the licensing authority makes arrangements under paragraph (7), it must publish a list of the EEA States or the organisation with which it has made such arrangements.]

Textual Amendments

F370Reg. 50(1A) inserted after subparagraph (1) (31.12.2020) by virtue of S.I. 2019/775, regs. 1, 49(1A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 37(a))

F371Words in reg. 50(2) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 50(2) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(c)

F377Words in reg. 50(5) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 6(4) and words in reg. 50(5) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 6(4)

F382Words in reg. 50(6) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 6(5) and words in reg. 50(6) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 6(5)

[F391Requirement for certain applications to include results of paediatric investigation planU.K.

50A.—(1) This regulation applies in relation to an application—

(a)under regulation 49 for a F392... UKMA(UK) for a relevant medicinal product which is an initial marketing authorisation for the purposes of a global marketing authorisation, as described in regulation 48(5), or

(b)under regulation 49 or 65C for a new indication (including a paediatric indication), a new pharmaceutical form or a new route of administration in relation to a relevant medicinal product which is already the subject of a UKMA(GB) or UKMA(UK).

(2) Paragraph (1)(b) only applies if the medicinal product in relation to which the new indication, new pharmaceutical form or new route of administration is sought is protected in the United Kingdom by a supplementary protection certificate or a patent which qualifies for the granting in the United Kingdom of a supplementary protection certificate.

(3) An applicant making an application to which this regulation applies must, in addition to the material specified in regulation 50, or in Schedule 10A, provide to the licensing authority the results of all studies performed, and details of all information collected, in compliance with an agreed paediatric investigation plan.

(4) Where paragraph (1)(b) applies, the material provided pursuant to paragraph (3) must cover both the existing and new indication, pharmaceutical form or route of administration.

(5) Paragraph (3) does not apply–

(a)to the extent that the licensing authority has, in relation to all or part of the paediatric population, granted—

(i)a deferral under regulation 50C of the initiation or completion of some or all of the measures set out in a paediatric investigation plan, or

(ii)a waiver under regulation 50D of the obligation to produce the information referred to in paragraph (3); or

(b)if one of regulations 51 to 54 applies to the application.

(6) The applicant making an application to which this regulation applies must include in the application details of the measures intended to ensure the follow up of efficacy and of possible adverse reactions to the paediatric use of the medicinal product.

(7) In the case of an application for a [F393UKMA(UK)(Category 2)] under the unfettered access route, an agreed paediatric investigation plan in respect of the product’s marketing authorisation in Northern Ireland applies also to that application as regards the UK marketing authorisation.

(8) This regulation does not remove, in respect of an application for [F394a UKMA(UK)(Category 2)], the obligation also to comply with the requirements of the Paediatric Regulation in connection with the agreement of, and compliance with, an EU agreed paediatric investigation plan in relation to Northern Ireland.

Textual Amendments

Agreement and modification of paediatric investigation planU.K.

50B.—(1) Any person may prepare a paediatric investigation plan for the purposes of an application to which regulation 50A applies and submit it to the licensing authority with a request for agreement.

(2) A paediatric investigation plan must—

(a)specify the timing and measures proposed to assess the safety, quality and efficacy of a medicinal product in the paediatric population; and

(b)describe any measures to adapt the formulation of the medicinal product so as to make its use more acceptable, easier, safer or more effective for different subsets of the paediatric population.

(3) A person who requests the agreement of a paediatric investigation plan must submit it to the licensing authority not later than upon completion of the human pharmaco-kinetic studies in adults in relation to the medicinal product to which the plan relates, as specified in section 5.2.3 of Part I of Annex I to the 2001 Directive, unless the licensing authority agrees to accept a later request.

(4) The licensing authority may request the person applying for agreement of a paediatric investigation plan to supply further information in relation to the plan or to submit proposed modifications to it.

(5) The licensing authority must decide whether or not—

(a)the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets of it; and

(b)the expected therapeutic benefits of the medicinal product justify the studies proposed; and

in doing so must consider whether or not the measures proposed to adapt the formulation of the medicinal product for use in different subsets of the paediatric population are appropriate.

(6) If, following a decision by the licensing authority to agree a paediatric investigation plan, the person carrying out the plan encounters such difficulties with its implementation as to render the plan unworkable or no longer appropriate, that person may propose changes or request a deferral or a waiver, by submitting a request to the licensing authority, explaining the grounds for the request.

(7) Schedule 11 makes provision about advice and representations in relation to proposals to agree, or to refuse to agree, a paediatric investigation plan under paragraph (5) or to grant, or to refuse to grant, a deferral or waiver requested under paragraph (6).

Textual Amendments

Deferral of initiation or completion of measures in paediatric investigation planU.K.

50C.—(1) At the same time as the paediatric investigation plan is submitted under regulation 50B(1), the person requesting agreement of it may request the agreement of the licensing authority to a deferral of the initiation or completion of some or all of the measures set out in the plan.

(2) If the licensing authority is satisfied that a deferral of the initiation or completion of some or all of the measures set out in a paediatric investigation plan can be justified on scientific and technical grounds, or on grounds related to public health, it may—

(a)agree to a request by the applicant to grant a deferral; or

(b)decide of its own motion to grant a deferral.

(3) If the licensing authority is satisfied as set out in paragraph (2), it must decide to grant a deferral where it is satisfied that—

(a)it is appropriate to conduct studies in adults prior to initiating studies in the paediatric population; or

(b)studies in the paediatric population will take longer to conduct than studies in adults.

(4) If the licensing authority grants an application to which regulation 50A applies, it must, if it also grants a deferral in accordance with this regulation—

(a)record that fact in the product's summary of product characteristics, and, if it considers that it would be appropriate to do so, in the package leaflet; and

(b)specify in the document notifying the applicant of the grant of the deferral the time limits for the initiation or completion of the measures to which the deferral relates.

(5) Schedule 11 makes provision about advice and representations in relation to proposals to grant, or to refuse to grant, a deferral under paragraph (2) or (3).

Textual Amendments

Waiver of production of information in a paediatric investigation planU.K.

50D.—(1) The applicant making an application to which regulation 50A applies is exempt from the obligation to provide to the licensing authority the results of all studies performed, and details of all information collected, in compliance with an agreed paediatric investigation plan, if a waiver is granted in accordance with this regulation.

(2) The licensing authority may grant a waiver in accordance with this regulation if it is satisfied that there is evidence showing that—

(a)the medicinal product or class of medicinal products is likely to be ineffective or unsafe in all or part of the paediatric population;

(b)the disease or condition for which the medicinal product or class of medicinal products is intended occurs only in adult populations; or

(c)the medicinal product does not represent a significant therapeutic benefit over existing treatments for patients in the paediatric population.

(3) The licensing authority may grant a waiver in accordance with this regulation—

(a)in respect of the entire paediatric population, or a subset of it;

(b)in respect of all of the therapeutic indications for the medicinal product concerned, or only some of them;

(c)of its own motion, or at the request of the applicant; or

(d)in respect of a specific product or a class of medicinal products.

(4) A person who requests a waiver in accordance with this regulation must submit the request to the licensing authority not later than upon completion of the human pharmaco-kinetic studies in adults in relation to the medicinal product concerned, as specified in section 5.2.3 of Part I of Annex I to the 2001 Directive, unless the licensing authority agrees to accept a later application.

(5) The licensing authority must maintain and publish a list of waivers which are granted under this regulation in respect of a class of medicinal products.

(6) The licensing authority may review a waiver which it has granted under this regulation and may revoke it if it considers it appropriate, having regard to the matters specified in paragraph (2).

(7) If the licensing authority revokes a waiver granted under this regulation, the holder of the UK marketing authorisation to which the waiver relates must, at the end of the period of 36 months beginning with the date of publication of the decision to revoke the waiver, submit the information referred to in regulation 50A(3) to the licensing authority.

(8) If the licensing authority grants an application to which regulation 50A applies, it must, if it also grants a waiver in accordance with this regulation, record that fact in the product's summary of product characteristics, and, if it considers that it would be appropriate to do so, in the package leaflet.

(9) Schedule 11 makes provision about advice and representations in relation to proposals to grant, or to refuse to grant, a waiver in response to a request made in accordance with paragraph (4) and to revoke a waiver under paragraph (6).

Textual Amendments

Application for paediatric use marketing authorisationU.K.

50E.—(1) This regulation applies in relation to an application for a F395... UKMA(UK)—

(a)for a relevant medicinal product which is not protected in the United Kingdom by a supplementary protection certificate or by a patent which qualifies for the granting of a supplementary protection certificate; and

(b)which covers exclusively therapeutic indications which are relevant for use in the paediatric population, or subsets of it, including the appropriate strength, pharmaceutical form or route of administration for that product.

(2) The applicant for a UK marketing authorisation to which this regulation applies must, in addition to the material specified in regulation 50, provide to the licensing authority material necessary to establish the quality, safety and efficacy of the product in the paediatric population, including any specific data needed to support an appropriate strength, pharmaceutical form or route of administration for the product, in accordance with an agreed paediatric investigation plan.

(3) An application to which this regulation applies may, in accordance with regulations 51 to 55, refer to material supplied by the holder of a UK marketing authorisation.

(4) The applicant for a UK marketing authorisation to which this regulation applies must include in the application details of the measures intended to ensure the follow up of efficacy and of possible adverse reactions to the paediatric use of the medicinal product.

(5) This regulation does not remove, in respect of an application for [F396a UKMA(UK)(Category 2)], the obligation also to comply with the requirements of the Paediatric Regulation in connection with the agreement of, and compliance with, an EU agreed paediatric investigation plan in relation to Northern Ireland.

Textual Amendments

Other applications including paediatric indicationsU.K.

50F.—(1) This regulation applies in relation to an application to which neither regulation 50A nor 50E applies and which is—

(a)an application for a [F397UKMA(UK)(Category 1)] for a relevant medicinal product which includes a paediatric indication; or

(b)an application to include a paediatric indication in an existing UKMA(GB) [F398or a UKMA(UK)(Category 1)].

(2) The applicant making an application to which this regulation applies must include in the application details of the measures intended to ensure the follow up of efficacy and of possible adverse reactions to the paediatric use of the medicinal product.

Textual Amendments

Applications relating to orphan medicinal productsU.K.

50G.—(1) This regulation applies in relation to an application for a UK marketing authorisation for a relevant medicinal product—

(a)in relation to which the applicant intends to demonstrate that the orphan criteria are met[F399.]

F400(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) The orphan criteria are that—

(a)the medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition;

(b)either—

(i)the condition referred to in sub-paragraph (a) affects not more than five in 10,000 persons in [F401the United Kingdom]; or

(ii)the medicinal product is unlikely, when marketed, to generate sufficient financial return to justify the necessary investment; and

(c)there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in [F401the United Kingdom], or if such method exists, the medicinal product will be of significant benefit to those affected by the condition.

(3) The applicant for a UK marketing authorisation to which this regulation applies must, in addition to the material specified in regulation 50, provide to the licensing authority material that demonstrates that the orphan criteria are met.

(4) Schedule 9A makes further provision about the orphan criteria and terms used in regulation 58D.

(5) The Ministers may by regulations amend Schedule 9A.

Textual Amendments

Applications relating to advanced therapy medicinal productsU.K.

50H.—(1) This regulation applies in relation to an application for [F402a UKMA(UK)(Category 1)] for a relevant medicinal product which is an advanced therapy medicinal product.

(2) The applicant for a UK marketing authorisation to which this regulation applies must, in addition to the material specified in regulation 50, provide to the licensing authority information about the measures the applicant envisages putting in place to ensure the follow up of the efficacy of the product and of any adverse reactions to it.

(3) In relation to an application for [F403a UKMA(UK)(Category 1)] for a combined advanced therapy medicinal product, the applicant must, in addition to the material specified in regulation 50 and paragraph (2), provide to the licensing authority evidence of conformity with the requirements of the Medical Devices Regulations 2002, including, where available, the results of the assessment of a notified body in accordance with those Regulations.

Textual Amendments

Applications relating to conditional marketing authorisations F404...U.K.

50I.—(1) This regulation applies in relation to an application for [F405a UKMA(UK)(Category 1)] for a relevant medicinal product which falls within paragraph (2).

(2) A relevant medicinal product falls within this paragraph if it is—

(a)aimed at the treatment, prevention or diagnosis of seriously debilitating or life-threatening diseases; or

(b)to be used in emergency situations, in response to public health threats.

(3) The applicant for a UK marketing authorisation to which this regulation applies may request that the licensing authority grant a conditional marketing authorisation if—

(a)comprehensive clinical data referring to the safety and efficacy of the medicinal product have not been supplied; and

(b)the applicant can demonstrate that—

(i)the positive therapeutic effects of the product outweigh the risks to the health of patients or of the public associated with the product,

(ii)it is likely that the applicant will be in a position to provide the comprehensive clinical data,

(iii)unmet medical needs will be fulfilled, and

(iv)the benefit to the public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required.

(4) In this regulation, “unmet medical needs” means medical needs in relation to a condition for which there exists no satisfactory method of diagnosis, prevention or treatment authorised in the United Kingdom, or, even if such method exists, in relation to which the medicinal product concerned will be of major therapeutic advantage to those affected.

(5) The applicant for a UK marketing authorisation to which this regulation applies must include in the application material which demonstrates that the criteria in paragraph (3)(b) are met.

Textual Amendments

Applications in relation to medicinal products containing or consisting of genetically modified organismsU.K.

50J.—(1) This regulation applies in relation to an application for a UK marketing authorisation for a relevant medicinal product which contains or consists of genetically modified organisms.

(2) The applicant for a UK marketing authorisation to which this regulation applies must, in addition to the material specified in regulation 50, provide to the licensing authority—

(a)a copy of the consent to the deliberate release into the environment of the genetically modified organisms for research and development purposes given pursuant to—

(i)regulation 21 of the Genetically Modified Organisms (Deliberate Release) Regulations 2002,

(ii)regulation 22 of the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002,

(iii)regulation 21 of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002, or

(iv)regulation 21 of the Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 2003;

(b)a complete technical dossier supplying the information specified in Annexes III and IV to Directive 2001/18/EC;

(c)an environmental risk assessment in accordance with the principles set out in Annex II to Directive 2001/18/EC; and

(d)the results of any investigations performed for the purposes of research or development.

(3) In this regulation, “genetically modified organism” has the meaning given in Article 2(2) of Directive 2001/18/EC.]

Textual Amendments

[F406Applications relating to POC medicinal productsU.K.

50K.—(1) This regulation applies in relation to an application for a UK marketing authorisation for a relevant medicinal product that is a POC medicinal product.

(2) The applicant for a UK marketing authorisation to which this regulation applies must, in addition to the material specified in regulation 50, provide to the licensing authority information about the measures the applicant envisages putting in place to ensure the follow up of the efficacy of the product and of any adverse reactions to it.]

Textual Amendments

[F407Application for UKMA(NI) relating to generic medicinal productsU.K.

51.—(1) An applicant for a UKMA(NI) for a relevant medicinal product that is a generic medicinal product may provide information in relation to the application in accordance with Article 10(1), (5) and (6) of the 2001 Directive.

(2) If the licensing authority grants a UKMA(NI) for the generic medicinal product in accordance with paragraph (1), it is a term of the authorisation that the product must not be sold or supplied, or offered for sale or supply, in Northern Ireland before the time at which it may be placed on the market in accordance with Article 10(1) of the 2001 Directive F408....

F409(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F410(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ]

Textual Amendments

Application for UKMA(GB) relating to generic medicinal productsU.K.

F41151A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F412Application for UKMA(UK) relating to generic medicinal productsU.K.

51B.—(1) An applicant for a UKMA(UK) for a generic medicinal product may, by way of derogation from paragraph 10 of Schedule 8, omit from the application the results of pre-clinical tests and of clinical trials if the applicant can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised for not less than eight years under regulation 49(1)(a) (subject to paragraphs (2) and (3)).

(2) In the case of an application under this regulation in relation to a salt, ester, ether, isomer, mixture of isomers, complex or derivative of an authorised active substance which differs significantly in properties with regard to safety or efficacy from the active substance in the reference medicinal product, the applicant must supply additional information providing proof of the safety or efficacy of the salt, ester, ether, isomer, mixture of isomers, complex or derivative.

(3) The applicant may omit bioavailability studies from an application under this regulation if the applicant can demonstrate that the generic medicinal product meets the relevant criteria as specified in the guidelines referred to in paragraph (4).

(4) The licensing authority may publish guidelines specifying the criteria to be met by generic medicinal products for the purpose of omitting bioavailability studies from an application in accordance with paragraph (3).

(5) Until replaced by guidelines published under paragraph (4), the guidelines published by the EMA under Article 10(2)(b) of the 2001 Directive continue to apply as they applied immediately before IP completion day (subject to any amendments or variations published under paragraph (4)).

(6) If the licensing authority grants a UKMA(UK) in relation to the generic medicinal product in accordance with paragraph (1), it is a term of the authorisation that the product must not be sold or supplied, or offered for sale or supply, in the United Kingdom before the expiry of ten years beginning with the date on which the UK marketing authorisation for the reference medicinal product was granted.

(7) If during the first eight of the ten years referred to in paragraph (6) the marketing authorisation holder for the reference medicinal product obtained a UK marketing authorisation for one or more new therapeutic indications, and, during the scientific evaluation prior to their authorisation, the licensing authority considers the new indications bring a significant clinical benefit in comparison with existing therapies, the period of ten years referred to in paragraph (6) is extended to eleven years.

(8) Where an application for grant or variation of a UKMA(UK) is made in relation to a new indication for a well-established substance; and significant pre-clinical or clinical studies were carried out in relation to the new indication, the applicant for a UKMA(UK) under paragraph (1) or regulation 52B or 53B, may not refer in its application to those studies for the period of one year beginning with the date on which the licensing authority grants or varies the UKMA(UK) in relation to the new indication.]

Textual Amendments

[F413Application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etcU.K.

52.—(1) This regulation applies where—

(a)an application is made for a UKMA(NI) by reference to another medicinal product as reference medicinal product; and

(b)one or more of the circumstances listed in Article 10(3) of the 2001 Directive applies in respect of the application.

(2) The applicant must provide information in accordance with Article 10(3) and (6) of the 2001 Directive.

(3) [F414Paragraph (2) of regulation 51 applies to the application as it applies] in relation to an application made in accordance with paragraph (1) of that regulation.]

Textual Amendments

Application for UKMA(GB) relating to certain medicinal products that do not qualify as generic etcU.K.

F41552A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F416Application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc.U.K.

52B.—(1) This Regulation applies where an application is made for a UKMA(UK) by reference to another medicinal product as reference medicinal product which is, or has been, authorised for not less than eight years under regulation 49(1)(a) and one or more of the following circumstances applies in respect of the application—

(a)the medicinal product to which the application relates does not fall within the definition of generic medicinal product;

(b)bioequivalence with the reference medicinal product cannot be demonstrated through bioavailability studies; or

(c)the medicinal product to which the application relates differs from the reference medicinal product in terms of changes in the active substance, therapeutic indications, strength, pharmaceutical form or route of administration.

(2) The applicant may, by way of derogation from paragraph 10 of Schedule 8, omit from the application the results of pre-clinical tests and of clinical trials relating to the reference medicinal product, but must provide the results of the appropriate pre-clinical tests or clinical trials relating to the applicable circumstances in paragraph (1).

(3) Paragraphs (2), (6) and (7) of regulation 51B apply to the application as they apply to an application made in accordance with paragraph (1) of that regulation.]

Textual Amendments

[F417Application for UKMA(NI) relating to similar biological medicinal productsU.K.

53.—(1) This regulation applies if an applicant for a UKMA(NI) for a biological medicinal product is not able to show that product meets a condition for its being a generic version of a similar medicinal product because of any of the reasons described in Article 10(4) of the 2001 Directive.

(2) The applicant must provide information in accordance with Article 10(4) and (6) of the 2001 Directive.

(3) [F418Paragraph (2) of regulation 51 applies to the application as it applies] in relation to an application made in accordance with paragraph (1) of that regulation.]

Textual Amendments

Application for UKMA(GB) relating to similar biological medicinal productsU.K.

F41953A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F420Application for UKMA(UK) relating to similar biological medicinal productsU.K.

53B.—(1) This regulation applies in relation to an application for a UKMA(UK) for a biological medicinal product where the applicant is not able to show that it meets a condition for it being a generic version of a similar medicinal product because of differences relating to raw materials or differences in manufacturing processes of the biological medicinal product and the reference medicinal product which is the subject of a UKMA(UK).

(2) The applicant may, by way of derogation from paragraph 10 of Schedule 8, omit from the application the results of pre-clinical tests and of clinical trials relating to a reference medicinal product which is or has been authorised for not less than eight years, but must provide the results of appropriate pre-clinical tests or clinical trials relating to the differences referred to in paragraph (1).

(3) The type and quantity of supplementary data to be provided by the applicant under paragraph (2) must comply with the relevant criteria in Annex 1 to the 2001 Directive and in the related detailed guidelines published by the licensing authority under paragraph (4), or (as the case may be) as mentioned in paragraph (5).

(4) The licensing authority may publish guidelines concerning the type and quantity of supplementary data to be provided by an applicant under paragraph (2).

(5) Unless replaced by guidelines published under paragraph (4), the guidelines published by the EMA under Article 10(4) of the 2001 Directive continue to apply as they applied immediately before IP completion day (subject to any amendments or variations published under that paragraph).

(6) If the licensing authority grants a UKMA(UK), in relation to the similar biological medicinal product in accordance with paragraph (2), it is a term of the authorisation that the product must not be sold or supplied, or offered for sale or supply, in the United Kingdom before the expiry of ten years beginning with the date on which the UK marketing authorisation for the reference medicinal product was granted.

(7) If during the first eight of the ten years referred to in paragraph (6), the marketing authorisation holder for the reference medicinal product requested and obtained a UKMA(UK) for one or more new therapeutic indications, and, during the scientific evaluation prior to their authorisation, the licensing authority considers that new indications bring a significant clinical benefit in comparison with existing therapies, the period of ten years is extended to eleven years.

(8) Where an application is made for the grant or variation of a UKMA(UK) in relation to a new indication for a well-established substance, and significant pre-clinical or clinical studies were carried out in relation to the new indication, the applicant for a UKMA(UK) under paragraph (1) may not refer in its application to those studies for the period of one year beginning with the date on which the licensing authority grants or varies a UKMA(UK) in relation to the new indication.]

Textual Amendments

Applications relating to products in well-established medicinal useU.K.

54.—(1) This regulation applies if an applicant for a UK marketing authorisation for a relevant medicinal product is able to demonstrate that the active substances of the product have been in well-established medicinal use within the [F421United Kingdom or the] European Union for at least 10 years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex I to the 2001 Directive.

[F422(2) The applicant may, by way of derogation from paragraph 10 of Schedule 8, replace the results of pre-clinical tests or clinical trials with appropriate scientific literature.]

Textual Amendments

Applications relating to new combinations of active substancesU.K.

[F42355.—(1) This regulation applies to an application for a UK marketing authorisation for a relevant medicinal product that contains active substances, provided those active substances—

(a)have not been used in that combination for therapeutic purposes; and

(b)where the application is for—

(i)a UKMA(NI), have been used in medicinal products that have been the subject of a marketing authorisation under these Regulations, the 2001 Directive or Regulation (EC) No 726/2004;

(ii)F424... or

(iii)a UKMA(UK), have been used in medicinal products that have been the subject of—

(aa)a UKMA(UK) under these Regulations; or

[F425(bb)a UKMA(NI).]

(2) The applicant must provide the results of new pre-clinical tests or new clinical trials relating to that combination in accordance with paragraph 10 of Schedule 8, but does not need to provide scientific references relating to each individual active substance.

F426(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Textual Amendments

Applications containing information supplied in relation to another product with consentU.K.

56.—(1) This regulation applies to an application for a UK marketing authorisation for a relevant medicinal product where—

(a)the product that is the subject of the application (“product A”) has the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form as a product (“product B”);

(b)product B is the subject of a UK marketing authorisation; and

(c)the holder of the marketing authorisation for product B has allowed use to be made of the pharmaceutical, pre-clinical and clinical documentation contained in the file on product B with a view to examining subsequent applications relating to other medicinal products possessing the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form.

(2) The documentation referred to in paragraph (1)(c) in relation to product B may be used in relation to the application in relation to product A F427...

Textual Amendments

Obligation to update information supplied in connection with applicationU.K.

57.—(1) The applicant for a UK marketing authorisation must update information supplied in accordance with paragraphs 18 to 21 of Schedule 8 (material to accompany an application for a UK marketing authorisation) in connection with the application.

(2) The applicant must update information supplied in connection with the application to include any further information that is relevant to the evaluation of the safety, quality or efficacy of the product concerned.

(3) Updated information within paragraphs (1) or (2) must be provided as soon as is reasonably practicable after the applicant becomes aware of it.

[F428Obligation to update information supplied in connection with parallel import licence applicationU.K.

57A.—(1) The applicant for a parallel import licence must update information supplied in accordance with Schedule 8A (material to accompany an application for a parallel import licence) in connection with the application.

(2) The applicant must update information supplied in connection with the application to include any further information that is relevant to the evaluation of the safety, quality or efficacy of the product concerned.

(3) Updated information within paragraphs (1) or (2) must be provided as soon as is reasonably practicable after the applicant becomes aware of it.]

Textual Amendments

Consideration of applicationU.K.

Consideration of applicationU.K.

58.—(1) The licensing authority must take all reasonable steps to ensure that it makes a decision to grant or refuse a UK marketing authorisation before the end of 210 days beginning immediately after the day on which the application for the authorisation is submitted in accordance with regulations 49 to 55.

(2) If the licensing authority requests the applicant to provide any further information or material, the period referred to in paragraph (1) is suspended for the period—

(a)beginning with the date on which the request is made; and

(b)ending with the date on which the information or material is provided.

(3) If the licensing authority requests the applicant to give an oral or written explanation of the application, the period referred to in paragraph (1) is suspended for the period—

(a)beginning with the date on which the request is made; and

(b)ending with the date on which the explanation is provided.

(4) The licensing authority may grant the application only if, having considered the application and the accompanying material, the authority thinks that—

(a)the applicant has established the therapeutic efficacy of the product to which the application relates;

(b)the positive therapeutic effects of the product outweigh the risks to the health of patients or of the public associated with the product;

(c)the application and the accompanying material complies with regulations 49 to 55; and

(d)the product's qualitative and quantitative composition is as described in the application and the accompanying material.

[F429(4A) When considering an application for a UK marketing authorisation, the licensing authority may, if it considers it appropriate, have regard to—

(a)an opinion of the Committee for Medicinal Products for Human Use; or

(b)the results of an assessment of an application for a marketing authorisation by the appropriate authority for the licensing of medicinal products of a country other than the United Kingdom,

in respect of the medicinal product to which the application relates.

(4B) The licensing authority may under paragraph (4A)—

(a)decide to have regard to the opinions and assessments described in that paragraph in relation to certain types of medicinal products only;

(b)determine and publish a list of the countries other than the United Kingdom whose assessments of applications for a marketing authorisation are relevant for the purposes of paragraph (4A)(b); and

(c)decide to have regard to the assessments described in paragraph (4A)(b) in relation to medicinal products that have been authorised by way of certain procedures only.

(4C) When considering an application for a UK marketing authorisation (other than an application under the unfettered access route), the licensing authority may, if it considers it appropriate and without undertaking further consideration, rely on a decision by the European Commission to authorise the medicinal product to which the application relates to establish that any or all of the conditions in paragraph (4)(a), (b) or (d) have been met.]

(5) Schedule 11 makes provision about advice and representations in relation to an application for the grant of a UK marketing authorisation.

F430(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F431(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F432(8) In the case of an application under the unfettered access route, the licensing authority may grant a [F433UKMA(UK)(Category 2)] (notwithstanding paragraph (4)) where the licensing authority—

(a)has considered the application under the unfettered access route and the accompanying material,

(b)is satisfied that the applicant has complied with the application requirements, and

(c)is satisfied that the conditions in regulation 50 will continue to be met.

(9) The licencing authority may refuse to grant an application under the unfettered access route where it is of the opinion that it would represent a risk to public health to do so.]

Textual Amendments

[F434Paediatric rewardsU.K.

58A.—( 1) Paragraph (2) applies if—

(a)an application—

(i)to which regulation 50A (requirement for certain applications to include the results of a paediatric investigation plan) applies, and in relation to which there is an agreed paediatric investigation plan; or

(ii)to which Article 7 or 8 of the Paediatric Regulation applies, and in relation to which there is an EU agreed paediatric investigation plan,

is granted by the licensing authority; and

(b)the licensing authority is satisfied that the material provided by the applicant pursuant to—

(i)regulation 50A(3), where paragraph (1)(a)(i) applies; or

(ii)Article 7 or 8 of the Paediatric Regulation, where paragraph (1)(a)(ii) applies,

demonstrates compliance with the agreed paediatric investigation plan.

(2) Where this paragraph applies, the licensing authority must—

(a)include in the UK marketing authorisation a statement to the effect that it is satisfied as set out in paragraph (1)(b); and

(b)ensure that the results of all studies referred to in the paediatric investigation plan are included in the summary of product characteristics and, if the licensing authority considers that the information would be useful to patients, in the package leaflet.

(3) Where—

(a)paragraph (2) applies[F435,]

F436(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

the holder of a patent or supplementary protection certificate covering the medicinal product to which the application relates is entitled to a six month extension of the period referred to in Articles 13(1) and 13(3) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (subject to paragraphs (4) to (5)).

(4) Paragraph (3) does not apply if the grant of the application referred to in paragraph (1)(a)—

(a)relates to a new paediatric indication; and

(b)the holder of the UK marketing authorisation is entitled to a one year extension of the ten year period referred to in [F437regulation 51B(6), under regulation 51B(7)].

(4A) Paragraph (3) does not apply where—

(a)the territorial protection conferred by the supplementary protection certificate referred to in paragraph (3) does not cover the whole of the United Kingdom; and

(b)the UK marketing authorisation in which the statement of compliance is included is not in force in the same part of the United Kingdom as the supplementary protection certificate.

(4B) Where—

(a)the territorial protection conferred by the supplementary protection certificate referred to in paragraph (3) does cover the whole of the United Kingdom; and

(b)the UK marketing authorisation in which the statement of compliance is included is in force in in Great Britain only or in Northern Ireland only,

the extension provided for in paragraph (3) only applies in relation to Great Britain only or Northern Ireland only (as appropriate).

(5) If the UK marketing authorisation to which this regulation applies is an orphan marketing authorisation, paragraph (3) does not apply and regulation 58D(5) (orphan rewards) applies.

(6) Paragraphs (7) and (8) apply if the licensing authority grants a UK marketing authorisation in response to an application to which regulation 50E (paediatric use marketing authorisation) applies.

(7) Where this paragraph applies, the medicinal product to which the paediatric use marketing authorisation relates may retain the name of any medicinal product which contains the same active substance and in respect of which the holder of the paediatric use marketing authorisation has been granted a UK marketing authorisation for use in adults.

(8) Where this paragraph applies, the holder of the paediatric use marketing authorisation is entitled to benefit from the periods of data and marketing exclusivity referred to in [F438regulation 51B(1) and (6)] in relation to the material supplied pursuant to regulation 50E(2).

Textual Amendments

Publication of information relating to paediatric marketing authorisationsU.K.

58B.—(1) The licensing authority must publish a register of UK marketing authorisations—

(a)which include a paediatric indication following completion of an agreed paediatric investigation plan; and

(b)in relation to which the medicinal product was placed on the market for other indications before the holder obtained that paediatric indication.

(2) The register referred to in paragraph (1) must include the date by which the product must be placed on the market taking account of the paediatric indication in accordance with regulation 78A(4) (post-authorisation requirements in relation to UK marketing authorisations to which paediatric specific provisions apply).

(3) The licensing authority must publish a list of the marketing authorisation holders which have—

(a)benefitted from any of the rewards in regulation 58A; or

(b)failed to comply with any of the obligations in regulation 78A.

(4) The licensing authority must publish decisions made under—

(a)regulation 50B(5) or (7) (agreement and modification of paediatric investigation plan);

(b)regulation 50C(2) (deferral of the initiation or completion of measures in a paediatric investigation plan); and

(c)regulation 50D(2) (waiver of production of information in a paediatric investigation plan) in relation to a specific medicinal product.

(5) The decisions referred to in paragraph (4) must be published, with the omission of information of a commercially confidential nature, as soon as reasonably practicable after the decision has been made.

Textual Amendments

Consideration of applications relating to orphan medicinal productsU.K.

58C.—(1) If the licensing authority is satisfied in relation to an application for a UK marketing authorisation (including an application under the unfettered access route)—

(a)the orphan criteria are met in relation to all of the therapeutic indications to which the application relates; and

(b)it is otherwise appropriate to grant a UK marketing authorisation in respect of the application under regulation 49(1)(a),

it may grant a UK marketing authorisation which is known as an orphan marketing authorisation.

(2) The licensing authority must publish and keep up to date a list of orphan marketing authorisations.

(3) Schedule 11 makes provision about advice and representations in relation to proposals to grant a UK marketing authorisation in respect of which the applicant intended to demonstrate that the orphan criteria were met, in cases where the licensing authority considers that those criteria are not met.

Textual Amendments

Orphan rewardsU.K.

58D.—(1) Subject to the following provisions of this regulation, for the period of ten years beginning with the date on which the licensing authority grants an orphan marketing authorisation, the licensing authority must not—

(a)grant an application for a UK marketing authorisation; or

(b)grant an application to vary a UK marketing authorisation;

in relation to a medicinal product which is similar to the medicinal product to which the orphan marketing authorisation relates and in respect of the therapeutic indications which are covered by the orphan marketing authorisation.

(4) The period of ten years referred to in paragraph (1) may be reduced to six years if, at the end of the fifth year beginning on the date referred to in paragraph (1), the licensing authority is satisfied that the orphan criteria are no longer met in relation to the medicinal product.

(5) The period of ten years referred to in paragraph (1) is extended to twelve years if regulation 58A(2) (paediatric rewards) applies to the orphan marketing authorisation.

(6) Paragraph (1) does not apply if—

(a)the holder of the orphan marketing authorisation consents to the grant or variation of a UK marketing authorisation in relation to a similar medicinal product;

(b)the licensing authority is satisfied that the holder of the orphan marketing authorisation is unable to supply sufficient quantities of the medicinal product to which the orphan marketing authorisation relates; or

(c)a subsequent applicant can establish to the satisfaction of the licensing authority that the medicinal product to which the application relates, although similar to the medicinal product to which the orphan marketing authorisation relates, is safer or more effective than, or clinically superior to, that product.

Textual Amendments

Consideration of applications relating to combined advanced therapy medicinal productsU.K.

58E.—(1) When determining an application to which regulation 50H(3) (applications relating to combined advance therapy medicinal products) applies, the licensing authority must—

(a)assess the entire combined advanced therapy medicinal product in accordance with these Regulations; and

(b)recognise the results of the assessment of the notified body, if supplied.

(2) The licensing authority may request the notified body, if relevant, to provide it with information related to the results of the assessment.

(3) Paragraph (4) applies if an application to which regulation 50H(3) applies does not include the results of the assessment of a notified body, or if the notified body fails to supply information related to the results of the assessment when requested by the licensing authority.

(4) Where this paragraph applies, the licensing authority must seek an opinion on the conformity of the device part in accordance with the Medical Devices Regulations 2002 from a notified body identified in conjunction with the applicant, unless the licensing authority decides that the involvement of a notified body is not required.

Textual Amendments

Consideration of applications relating to conditional marketing authorisationsU.K.

58F.—(1) If the licensing authority is satisfied in relation to an application to which regulation 50I (applications relating to conditional marketing authorisations) applies that—

(a)the criteria in regulation 50I(3)(b) are met; and

(b)it is otherwise appropriate to grant a [F439UKMA(UK)(Category 1)] in respect of the application in accordance with regulation 49(1)(a),

it may grant a UK marketing authorisation which is known as a conditional marketing authorisation.

(2) Where regulation 50I(2)(b) (applications relating to conditional marketing authorisations) applies, the licensing authority may grant a conditional marketing authorisation if, in addition to comprehensive clinical data, comprehensive pre-clinical or pharmaceutical data have not been supplied.

(3) The licensing authority may, of its own motion, propose that a conditional marketing authorisation be granted if, having consulted the applicant for a UK marketing authorisation, it considers that the criteria in regulation 50I(3)(b) are met.

(4) If the licensing authority grants a conditional marketing authorisation in relation to a medicinal product, it may at any time decide that it is appropriate to grant a UK marketing authorisation in relation to that product which is not a conditional marketing authorisation.

(5) If the licensing authority grants a conditional marketing authorisation, the product's summary of product characteristics and package leaflet must include a statement to that effect, and the summary of product characteristics must include the date on which the conditional marketing authorisation is due for renewal.

Textual Amendments

Consideration of applications in relation to medicinal products containing or consisting of genetically modified organismsU.K.

58G.—(1) When determining an application for a UK marketing authorisation in relation to which regulation 50J (applications relating to medicinal products containing or consisting of genetically modified organisms) applies, the licensing authority must be satisfied that the application respects the environmental safety requirements laid down by Directive 2001/18/EC.

(2) In reaching its view under paragraph (1), the licensing authority must consult the bodies responsible for the giving of consent pursuant to the legislation referred to in regulation 50J(2)(a).]

Textual Amendments

Conditions of UK marketing authorisation [F440or parallel import licence]: generalU.K.

59.—(1) [F441Unless paragraph (1A) applies the licensing authority] may—

(a)grant a UK marketing authorisation subject to one or more of the conditions in paragraph (2); or

(b)vary or remove a condition in paragraph (2) to which the UK marketing authorisation is subject.

[F442(1A) Where the application concerns a parallel import licence, the licensing authority may—

(a)grant a parallel import licence subject to one or more of the conditions in paragraph (2)(a), (c), (d) or (e); or

(b)vary or remove a condition in paragraph (2)(a), (c), (d) or (e) to which the parallel import licence is subject.]

(2) Those conditions are—

(a)to take certain measures for ensuring the safe use of the medicinal product and include them in the risk management plan;

(b)to conduct post-authorisation safety studies;

(c)to comply with obligations on the recording or reporting of suspected adverse reactions which are stricter than those referred to in Part 11;

(d)any other conditions or restrictions with regard to the safe and effective use of the medicinal product;

(e)the existence of an adequate pharmacovigilance system; and

(f)to conduct post-authorisation efficacy studies where concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed.

(3) [F443In relation to a UKMA(NI) or [F444UKMA(UK)(Category 2)], an obligation] to conduct such studies as are referred to in paragraph (2)(f) must be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive, while taking into account the scientific guidance referred to in Article 108a of the 2001 Directive.

[F445(3A) In relation to a UKMA(GB) [F446or a UKMA(UK)(Category 1)], an obligation to conduct such studies as are referred to in paragraph (2)(f) must—

(a)be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive; and

(b)take into account the scientific guidance that applies under regulation 205B in relation to post-authorisation efficacy studies.

(3B) The Secretary of State may by regulations make provision F447... specifying the situations in which post-authorisation efficacy studies may be required [F448in relation to a UKMA(GB) or UKMA(UK)(Category 1)] by virtue of the condition referred to in paragraph (2)(f).

(3C) Paragraph (3A)(a) ceases to apply on the coming into force of regulations made under paragraph (3B).]

(4) The [F449UK] marketing authorisation [F450or parallel import licence] must lay down deadlines for the fulfilment of the conditions in paragraph (2) [F451where relevant and necessary].

[F452(4A) Where the application is one to which regulation 50A, 50E or 50F (applications to which paediatric-specific provisions apply) applies, the licensing authority must, if it considers that there is a particular cause for concern, grant the UK marketing authorisation subject to a condition that—

(a)a risk management system be set up comprising a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those interventions; or

(b)specific post-marketing studies be performed and submitted for review.

(4B) The licensing authority may request the holder to submit, in addition to the assessment required to be submitted pursuant to Part 9 of Schedule 12A (post-authorisation safety studies), a report assessing the effectiveness of any risk management system, and the results of any studies performed, in compliance with a condition imposed under paragraph (4A).

(4C) If the licensing authority grants a conditional marketing authorisation—

(a)it must impose, as a condition of the conditional marketing authorisation, an obligation on the holder of the authorisation to complete ongoing studies, or to conduct new studies, with a view to confirming the that the positive therapeutic effects of the product outweigh the risks to the health of patients or the public associated with the product, and to provide the additional data referred to in regulation 50I(3)(a);

(b)it may impose, as a condition of the conditional marketing authorisation, an obligation on the holder of that authorisation in relation to collection of pharmacovigilance data.

(4D) If the licensing authority grants a UK marketing authorisation in relation to an advanced therapy medicinal product, it must, if it considers that there is a particular cause for concern, grant the UK marketing authorisation subject to a condition that—

(a)a risk management system be set up which is designed to identify, characterise, prevent or minimise risks related to advanced therapy medicinal products, including an evaluation of the effectiveness of that system; or

(b)that specific post-marketing studies be carried out and submitted for review by the licensing authority.

(4E) The licensing authority may request the holder to submit, in addition to the assessment required to be submitted pursuant to Part 9 of Schedule 12A, a report assessing the effectiveness of any risk management system, and the results of any studies performed, in compliance with a condition imposed under paragraph (4D).]

(5) The licensing authority must notify the EMA of any [F453UKMA(NI) or] [F454UKMA(UK)(Category 2)] that it has granted subject to a condition included in accordance with this regulation.

(6) The holder of the authorisation must incorporate any condition included in a marketing authorisation [F455or parallel import licence] in accordance with this regulation into the risk management system for the product.

(7) Schedule 11 makes provision about advice and representations in relation to proposals to vary or remove a condition to which a UK marketing authorisation is subject.

Textual Amendments

F440Words in reg. 59 heading inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 59 heading inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(d)

F441Words in reg. 59(1) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 8(2) and words in reg. 59(1) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 8(2)

F450Words in reg. 59(4) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 59(4) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(e)

F451Words in reg. 59(4) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 8(4) and words in reg. 59(4) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 8(4)

F455Words in reg. 59(6) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 59(6) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(e)

Conditions of UK marketing authorisation [F456or parallel import licence]: exceptional circumstancesU.K.

60.—(1) The licensing authority may—

(a)grant a UK marketing authorisation [F456or parallel import licence] subject to conditions in accordance with the following paragraphs of this regulation; or

(b)vary or remove such a condition to which the UK marketing authorisation [F456or parallel import licence] is subject.

(2) The powers in paragraph (1) may be exercised only after consultation with the applicant for the authorisation [F457or licence] or (as the case may be) its holder.

(3) The power in paragraph (1)(a) to grant an authorisation [F458or licence] subject to conditions may be exercised only—

(a)in exceptional circumstances; and

(b)when the applicant can show that the applicant is unable to provide comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use.

(4) The conditions must relate to a matter addressed by Annex I to the 2001 Directive.

(5) The conditions may, in particular, relate to the safety of the product to which the authorisation [F457or licence] relates.

(6) The conditions may, in particular, require that, where there is a serious adverse reaction relating to the use of the product—

(a)the reaction must be reported to the licensing authority; and

(b)such other action as may be specified in the conditions must be taken.

(7) The licensing authority must keep under review—

(a)the conditions under this regulation to which a UK marketing authorisation [F456or parallel import licence] is subject; and

(b)the holder's compliance with those conditions.

(8) The licensing authority must consider those matters no less frequently than—

(a)at the end of the period of one year beginning with the date on which the authorisation [F457or licence] was granted; and

(b)at the end of each subsequent period of one year.

[F459(9) The licensing authority must notify the EMA of any UKMA(NI) or [F460UKMA(UK)(Category 2)] that it has granted subject to a condition included in accordance with this regulation.]

(10) The holder of the authorisation [F457or licence] must incorporate any condition included in a marketing authorisation [F461or licence] in accordance with this regulation into the risk management system for the product.

(11) Schedule 11 makes provision about advice and representations in relation to proposals to vary or remove a condition to which a UK marketing authorisation [F456or parallel import licence] is subject.

Textual Amendments

[F462Condition as to the submitting of samples and other information to the appropriate authority U.K.

60A.—(1) In this regulation—

“the appropriate authority” is to be construed in accordance with section 57(7) of the Health and Social Care Act 2012;

“appropriate documentation”, in relation to a sample of a batch submitted to the appropriate authority in accordance with the batch testing condition or pursuant to a notification under paragraph (12), means—

(a)

any certificate issued by a laboratory in an approved country for batch testing and certification of biological medicinal products that relates to the sample of the batch submitted to the appropriate authority with that certificate; and

(b)

such other documentation as the appropriate authority notifies the holder of the UK marketing authorisation to which the sample relates that it requires;

“approved country list for batch testing and certification of biological medicinal products” means the list described in paragraph (5), and “approved country for batch testing and certification of biological medicinal products” means a country included in that list;

“the batch testing condition”, in respect of a UK marketing authorisation, is a condition to the effect that, unless the batch testing exemption applies, the holder of the UK marketing authorisation—

(a)

must submit a sample from each batch of the medicinal product that is the subject of that authorisation to the appropriate authority, together with appropriate documentation; and

(b)

must not sell or supply, or offer to sell or supply, a medicinal product that forms part of that batch in the United Kingdom until the appropriate authority has examined—

(i)

the sample from that batch,

(ii)

the appropriate documentation, or

(iii)

both that sample and that documentation,

and confirmed that it is satisfied that the batch is in conformity with the approved specifications in the UK marketing authorisation; and

[F463“the batch testing exemption” means that—

(a)

in the case of a medicinal product for sale or supply in Northern Ireland only and authorised under a UKMA(NI) or a UKMA(UK)(Category 2), a certificate—

(i)

has been issued by a laboratory in an EEA State, and

(ii)

in the case of a product of a kind listed in Article 114(1) of the 2001 Directive, was issued in the same EEA State as that in which the batch was manufactured, and

the appropriate authority is satisfied that the certificate provides confirmation of conformity with the approved specifications in the UKMA(NI) or UKMA(UK)(Category 2), as applicable, or

(b)

in the absence of such a certificate, or in the case of a medicinal product authorised for sale or supply under a UKMA(GB) or a UKMA(UK)(Category 1)—

(i)

a certificate has been issued by a laboratory in a country other than the United Kingdom,

(ii)

an agreement has been made between that country and the United Kingdom (whether or not the agreement is solely with that country, a group of countries or an organisation of which that country is a part), and

(iii)

that agreement is to the effect that the appropriate authority will recognise that certificate in respect of the batch of the medicinal product, in place of the appropriate authority’s own examination of a sample from the batch, the appropriate documentation or both.]

(2) The licensing authority may impose the batch testing condition in respect of a UK marketing authorisation for a medicinal product that is—

(a)a live vaccine;

(b)an immunological product used in the primary immunisation of infants or other groups at risk;

(c)an immunological product used in public health immunisation programmes;

(d)subject to paragraph (3), a new immunological product manufactured using new or altered kinds of technology or new for a particular manufacturer; or

(e)derived from human blood or human plasma.

(3) If the licensing authority imposes a condition in respect of a UK marketing authorisation for a medicinal product of a kind mentioned in paragraph (2)(d), it must, in imposing that condition, specify a period of time for the duration of the condition.

(4) The appropriate authority must complete its examination of the sample for testing, the appropriate documentation or both (as the case may be) within the period of 60 days, beginning with the date on which the appropriate authority is in receipt of both the sample for testing, and the appropriate documentation.

(5) The appropriate authority must publish a list, to be known as the approved country list for batch testing and certification of biological medicinal products, specifying the countries that are approved for the purposes of the appropriate authority's assessment under paragraph (6) F464....

(6) Where a holder of a UK marketing authorisation, in order to comply with the batch testing condition, submits appropriate documentation that includes a certificate issued by a laboratory in an approved country for batch testing and certification of biological medicinal products in respect of the batch, the appropriate authority must, in addition to any other factors it considers relevant, take that into account in determining whether the appropriate authority needs to undertake any further testing of the medicinal product submitted to it.

(7) In order to determine whether a country should be included in the approved country list for batch testing and certification of biological medicinal products, the appropriate authority may, in particular, take into account whether the relevant certification process in that country is based on testing performed under a quality assurance system that undergoes regular external assessment to ensure it meets an appropriate standard of competence for testing biological medicines.

(8) The appropriate authority must—

(a)review the countries it has included in the approved country list for batch testing and certification of biological medicinal products to determine if it is still satisfied that the country should remain on that list, and if it is not so satisfied, remove that country from the list; and

(b)undertake that review at least every three years beginning with the date on which that country is included in the list.

(9) The appropriate authority must—

(a)publish a list of countries, or organisations, with whom the United Kingdom has an agreement for the purposes of the application of the batch testing exemption under this regulation F465...;

(b)include in that list any conditions or restrictions in that agreement that affect the applicability of the batch testing exemption under this regulation F466...; and

(c)update that list as soon as reasonably practicable if—

(i)the United Kingdom no longer has an agreement with a country or organisation included in the list,

(ii)any such agreement is amended, or

(iii)the United Kingdom enters in to a new agreement with a country or organisation.

(10) [F467Subject to paragraph (10A), where] a holder of a UK marketing authorisation relies on the batch testing exemption in relation to a batch of a medicinal product, that holder must submit the certificate in respect of that batch to the licensing authority and the appropriate authority, and such other documentation as those authorities may notify that holder they require, before it sells or supplies, or offers to sell or supply, a medicinal product that forms part of that batch in the United Kingdom.

[F468(10A) Where a holder of a UK marketing authorisation intends to rely on paragraph (a) of the batch testing exemption in relation to a batch of a medicinal product, that holder must not sell or supply, or offer to sell or supply, in Northern Ireland, a medicinal product that forms part of that batch until the appropriate authority has confirmed that it is satisfied as set out in that paragraph.]

(11) Paragraph (12) applies where the appropriate authority considers that there are public health concerns in respect of a batch of a medicinal product (“the relevant batch”) in relation to which the batch testing exemption would otherwise apply.

(12) Where this paragraph applies, the appropriate authority must, subject to paragraph (13), notify the holder of the UK marketing authorisation in respect of the relevant batch that it nevertheless requires that holder—

(a)to submit a sample from the relevant batch to the appropriate authority, together with appropriate documentation; and

(b)not to sell or supply, or to offer to sell or supply, a medicinal product that forms part of that batch in the United Kingdom until the appropriate authority has examined—

(i)the sample from that batch,

(ii)the appropriate documentation, or

(iii)both that sample and that documentation,

and confirmed that it is satisfied that the relevant batch is in conformity with the approved specifications in the UK marketing authorisation.

(13) The appropriate authority may only exercise its powers under paragraph (12) if the agreement made between the country in which the certificate was issued, and the United Kingdom (whether the agreement is solely with that country, a group of countries or an organisation of which that country is a part) provides for the relevant batch to be re-examined by the appropriate authority in the circumstances described in paragraph (11).

(14) The appropriate authority may, in any particular case, apply this regulation to a medicinal product imported into the United Kingdom pursuant to a parallel import licence and accordingly any reference in this regulation to—

(a)a UK marketing authorisation should be read as a reference to a parallel import licence for a medicinal product,

(b)the holder of a UK marketing authorisation should be read as a reference to the holder of a parallel import licence, and

(c)the approved specifications in a UK marketing authorisation should be read as a reference to the approved specifications in the UK reference product specified for the purposes of the parallel import licence in accordance with paragraph 4 of Schedule 8A.

(15) Where, pursuant to paragraph (14), this regulation is applied to a medicinal product imported into the United Kingdom pursuant to a parallel import licence, sub-paragraph (a) of the definition of “the batch testing exemption” does not apply.

(16) In the application of this regulation to a medicinal product for sale or supply in Northern Ireland only to which Article 114 of the 2001 Directive applies, a reference in this regulation to a laboratory is to an Official Medicines Control Laboratory or a laboratory referred to in that Article.]

Textual Amendments

Submitting of samples and other information: EU marketing authorisationsU.K.

F46960B.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Conditions of UK marketing authorisation: new obligations post-authorisationU.K.

61.—(1) After the granting of a UK marketing authorisation, the licensing authority may impose an obligation on the holder of the authorisation in accordance with either or both of —

(a)paragraph (4), in a case where paragraph (2) applies; or

(b)paragraph (5), in a case where paragraph (3) applies.

(2) This paragraph applies if there are concerns about the risks of a medicinal product that is the subject of a marketing authorisation.

(3) This paragraph applies if the understanding of the disease or the clinical methodology indicate that previous efficacy evaluations might have to be revised significantly.

[F470(4) The obligation in this paragraph is—

(a)to conduct a post-authorisation safety study; or

(b) in relation to a UKMA(GB) [F471or UKMA(UK)(Category 1)], to comply with such other conditions or restrictions as the licensing authority considers essential for the safe and effective use of the medicinal product.]

(5) The obligation in this paragraph is to conduct a post-authorisation efficacy study.

(6) If concerns as described in paragraph (2) apply to more than one medicinal product [F472authorised by a UKMA(NI) [F473or UKMA(UK)(Category 2)]], the licensing authority shall, following consultation with the Pharmacovigilance Risk Assessment Committee, encourage the marketing authorisation holders concerned to conduct a joint post-authorisation safety study.

[F474(6A) If concerns as described in paragraph (2) apply to more than one medicinal product authorised by a UKMA(GB) [F475or UKMA(UK)(Category 1)], the licensing authority—

(a)must, where the obligation is to conduct a post-authorisation safety study, encourage the UK marketing authorisation holders concerned to conduct a joint study, and

(b)may, where the obligation is to comply with any other conditions or restrictions, encourage the UK marketing authorisation holders concerned to take co-ordinated action to comply with the conditions or restrictions.]

[F476(7) The obligation under paragraph (5) must be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive while taking account of the scientific guidance that applies under regulation 205B in relation to post-authorisation efficacy studies.]

F477[F478(7A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7B) The Secretary of State may by regulations make provision in respect of Great Britain specifying the situations in which post-authorisation efficacy studies may be required by virtue of the obligation under paragraph (5).

(7C) Paragraph (7A)(a) ceases to apply on the coming into force of regulations made under paragraph (7B).]

(8) Where the licensing authority imposes an obligation under paragraph (4) or (5), it must without delay give written notice to the holder of —

(a)the imposition of the obligation;

(b)the justification for the imposition;

(c)the objectives and timeframe for submission and conduct of the study; and

(d)the opportunity to present written observations in accordance with paragraph (9) and the time limit specified for doing so.

(9) Where the holder so requests within the period of thirty days beginning on the day after the receipt by the holder of the notice referred to in paragraph (8), the licensing authority must provide the holder of the authorisation with an opportunity to present written observations in response to the imposition of the obligation within the time limit specified by the licensing authority in the notice.

(10) Where the holder presents written observations under paragraph (9), the licensing authority must withdraw or confirm the imposition of the obligation under paragraph (4) or (5) on the basis of the written observations as soon as is reasonably practicable.

(11) Paragraph (12) applies where the licensing authority—

(a)imposes an obligation under paragraph (4) or (5) and the holder does not present written representations under paragraph (9); or

(b)confirms the imposition of an obligation under paragraph (10).

(12) Where this paragraph applies, the licensing authority must vary the marketing authorisation to include the obligation as a condition of the marketing authorisation as if it were a condition imposed under regulation 59 (conditions of UK marketing authorisations: general).

(13) The licensing authority must notify the EMA [F479, in relation to a UKMA(NI) [F480or UKMA(UK)(Category 2)],] that the marketing authorisation is subject to a condition included in accordance with paragraph (12).

(14) The holder of the authorisation must incorporate any condition included in a marketing authorisation in accordance with paragraph (12) into the risk management system for the product.

(15) Schedule 11, which makes provision about advice and representations in relation to proposals to vary or remove a condition to which a UK marketing authorisation is subject, shall apply in relation to the variation or removal of a condition included in a marketing authorisation in accordance with paragraph (12).

Textual Amendments

Classification of UK marketing authorisation [F481or parallel import licence]U.K.

62.—(1) A UK marketing authorisation [F482or parallel import licence] must include a term that the product to which the authorisation relates is to be available—

(a)only on prescription;

(b)only from a pharmacy; or

(c)on general sale.

(2) In making a determination under paragraph (1), the licensing authority must have regard to the following in relation to the product—

(a)the maximum single dose;

(b)the maximum daily dose;

(c)the strength of the product;

(d)its pharmaceutical form;

(e)its packaging; and

(f)such other circumstances relating to its use as the licensing authority considers relevant.

(3) A UK marketing authorisation [F483or parallel import licence] must be granted subject to a condition that the product to which the authorisation relates is to be available only on prescription if the licensing authority considers that the product—

(a)is likely to present a direct or indirect danger to human health, even when used correctly, if used without the supervision of a doctor or dentist;

(b)is frequently and to a very wide extent used incorrectly, and as a result is likely to present a direct or indirect danger to human health;

(c)contains substances, or preparations of substances, of which the activity requires, or the side effects require, further investigation; or

(d)is normally prescribed by a doctor or dentist for parenteral administration.

(4) In deciding whether paragraph (3) applies to a product, the licensing authority must take into account whether the product—

(a)contains a substance listed in any of Schedules I, II or IV to the Narcotics Drugs Convention (where the product is not a preparation listed in Schedule III to that Convention);

(b)contains a substance listed in any of Schedules I to IV of the Psychotropic Substances Convention (where the product is not a preparation which may be exempted from measures of control in accordance with paragraphs 2 and 3 of article 3 of that Convention);

(c)is likely, if incorrectly used—

(i)to present a substantial risk of medicinal abuse,

(ii)to lead to addiction, or

(iii)to be used for illegal purposes;

(d)contains a substance that, by reason of its novelty or properties, might fall within paragraph (c), but as to which there is insufficient information available to determine whether it does so fall;

(e)by reason of its pharmaceutical characteristics or novelty, or in the interests of public health, is reserved for treatments that can only be followed in a hospital;

(f)is used in the treatment of conditions that must be diagnosed in a hospital or in an institution with special diagnostic facilities (although administration and subsequent supervision may be carried out elsewhere); or

(g)is intended for outpatients but may produce very serious side effects which would require a prescription drawn up as required by a specialist and special supervision throughout the treatment.

(5) A UK marketing authorisation [F484or parallel import licence] may include a term that the product to which the authorisation relates is to be available on general sale only if the licensing authority considers that the product can with reasonable safety be sold or supplied otherwise than by, or under the supervision of, a pharmacist [F485or by a person who acts in accordance with regulation 220A or 220B (or an exemption in Chapter 3 of Part 12)].

Textual Amendments

F481Words in reg. 62 heading inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 62 heading inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(f)

F482Words in reg. 62(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 62(1) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(g)

F483Words in reg. 62(3) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 62(3) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(g)

F484Words in reg. 62(5) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 62(5) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(g)

Frequency of periodic safety update reportsU.K.

63.—(1) The licensing authority must, if paragraph (2) applies, include in a UK marketing authorisation a term that specifies the frequency, calculated from the date on which the authorisation is granted, with which the holder of the authorisation must submit periodic safety update reports in accordance with regulation 191(8) (obligation on holder to submit periodic safety update reports: general requirements).

(2) This paragraph applies in the case of a medicinal product in relation to which regulation 191(8) applies by virtue of regulation 191(1).

Duties of licensing authority in connection with determinationU.K.

64.—(1) This regulation applies if the licensing authority grants a UK marketing authorisation.

(2) The licensing authority must inform the holder of the authorisation of the summary of the product characteristics as approved by the authority.

(3) The licensing authority must ensure that the summary of the product characteristics continues to match the version it has approved, subject to any changes it approves.

(4) As soon as is reasonably practicable after granting the marketing authorisation, the licensing authority must make available publicly—

(a)the marketing authorisation;

(b)the package leaflet;

(c)the summary of the product characteristics;

[F486(d)any conditions—

(i)in the case of a UKMA(NI) [F487or UKMA(UK)(Category 2)], established in accordance with Articles 21a, 22 and 22a of the 2001 Directive;

(ii)in the case of UKMA(GB) [F488or UKMA(UK)(Category 1)], imposed under regulations 59 to 61; and]

(e)any deadlines for the fulfilment of those conditions.

(5) The licensing authority must draw up an assessment report and make comments on the file as regards—

(a)the results of the pharmaceutical and pre-clinical tests, the clinical trials, the risk management system and the pharmacovigilance system of the product to which the authorisation relates; or

(b)in the case of a national homoeopathic medicinal product within the meaning of Schedule 10, the information submitted under paragraphs 3 to 5 of that Schedule.

(6) The licensing authority must—

(a)revise the assessment report whenever new information becomes available that is of importance for the evaluation of the quality, safety or efficacy of the medicinal product;

(b)make the assessment report publicly available (with the omission of information of a commercially confidential nature) as soon as is reasonably practicable after it has been prepared or revised; and

(c)include in the assessment report a summary, written in a manner that is understandable to the public, that contains, in particular, a section relating to the conditions of use of the medicinal product.

(7) The assessment must be provided separately for each indication that is authorised.

Textual Amendments

[F489Obligation of licensing authority in case of change of classificationU.K.

64A.—(1) In this regulation, “classification”, in relation to a medicinal product, means the term of the product's UK marketing authorisation which determines the way in which the product is to be made available, as described in regulation 62(1).

(2) This regulation applies where—

(a)the licensing authority grants or varies—

(i)a UK marketing authorisation;

(ii)an Article 126a authorisation;

(iii)a traditional herbal registration; or

(iv)a certificate of registration of a homoeopathic medicinal product;

(b)the grant or variation of the UK marketing authorisation involves a change of the classification of the medicinal product to which the authorisation relates; and

(c)the application for the UK marketing authorisation or variation was supported by the results of significant pre-clinical tests or clinical trials relating to the proposed classification.

(3) Where this regulation applies, the licensing authority may not, for the period of one year beginning with the date on which the UK marketing authorisation was granted or varied, refer to the results of the tests or trials referred to in paragraph (2)(c) when examining an application by another applicant or UK marketing authorisation holder for a change of classification of the same kind as that to which the tests or trials relate.]

Textual Amendments

Validity of UK marketing authorisationU.K.

Validity of UK marketing authorisationU.K.

65.—(1) Subject to the following paragraphs, a UK marketing authorisation remains in force—

(a)for an initial period of five years beginning with the date on which it is granted; and

(b)if the authorisation is renewed in accordance with regulation 66, for an unlimited period after its renewal.

(2) The licensing authority may, on the first application for renewal of an authorisation, determine on grounds relating to pharmacovigilance, including exposure of an insufficient number of patients to the medicinal product concerned, that it should be necessary for the holder to make one further application for renewal.

(3) In that event the authorisation remains in force—

(a)for a further period of five years beginning with the date on which it is first renewed; and

(b)if the authorisation is further renewed under regulation 66, for an unlimited period after its further renewal.

(4) If an application for the renewal or further renewal of an authorisation is made in accordance with regulation 66 the authorisation remains in force until the licensing authority notifies the applicant of its decision on the application.

(5) This regulation is subject to—

[F490(za)regulation 65B;]

(a)regulation 67 (failure to place on the market etc); and

(b)regulation 68 (revocation etc of marketing authorisations).

Textual Amendments

[F491Validity of parallel import licenceU.K.

65A.—(1) Unless paragraph (2) applies, a parallel import licence remains in force for a period of 5 years from the date it is granted or renewed.

(2) A parallel import licence will cease to be valid if—

(a)the information supplied in the application for a licence no longer matches the information currently approved for the reference product by the licensing authority;

(b)details about the product imported under the licence are not consistent with the details supplied in the application; or

(c)the patient information leaflet supplied with the product is not consistent with latest version of the leaflet that is required to be issued with the product by the licensing authority, and

an application to vary the licence to update any details in relation to sub-paragraph (a) to (c) has not been granted by the licensing authority because the condition in regulation 68(11) has not been met.]

Textual Amendments

[F492Validity of conditional marketing authorisationU.K.

65B.—(1) A conditional marketing authorisation remains in force—

(a)for an initial period of one year beginning with the date on which it is granted; and

(b)if it is renewed in accordance with regulation 66B, for further periods of one year beginning with the date on which the renewal is granted.

(2) If an application for the renewal or further renewal of a conditional marketing authorisation is made in accordance with regulation 66B the authorisation remains in force until the licensing authority notifies the applicant of its decision on the application.

Textual Amendments

Variation of a UKMA(GB) [F493or a UKMA(UK)(Category 1)]U.K.

65C.—(1) A UKMA(GB) [F494or a UKMA(UK)(Category 1)] holder may apply to vary the authorisation.

(2) Any such application must be made in accordance with Schedule 10A.

(3) Schedule 10A does not apply to the transfer of a UKMA(GB) [F495or a UKMA(UK)(Category 1)] from one person to another.

(4) The licensing authority may publish guidance on the details of the various categories of variations, on the operation of the procedures laid down in Schedule 10A, and on the documentation to be submitted pursuant to those procedures.

(5) Any guidance referred to in paragraph (4) must be regularly reviewed and, when necessary, updated.

(6) Unless replaced by guidelines published under paragraph (4), the guidelines published by the Commission under Article 4 of Regulation (EC) No 1234/2008 which applied immediately before IP completion day, insofar only as they concern applications under Chapter IIa of that Regulation, continue to apply to—

(a)applications made under regulation 65C on or after IP completion day; or

(b)applications made before IP completion day to which regulation 65C and Schedule 10A apply by virtue of Parts 3 and 5 of Schedule 33A.

(7) The Ministers may by regulations amend Schedule 10A.]

Textual Amendments

Application for renewal of authorisationU.K.

66.—(1) The licensing authority may renew a UK marketing authorisation in response to an application made in accordance with this regulation.

[F496(2) The applicant, where it is applying for renewal of—

[F497(a)a UK marketing authorisation, must, subject to sub-paragraph (b), be established in the UK or an EEA State; and]

(b)a [F498UKMA(UK)(Category 2)]—

(i)under the unfettered access route, must be established in Northern Ireland;

F499(ii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F500(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

(3) The application must be—

(a)made in writing;

(b)signed by or on behalf of the applicant; and

(c)unless the licensing authority directs otherwise, accompanied by any fee payable in connection with the application.

(4) An application is treated as signed for the purposes of paragraph (3)(b) if it is signed with an electronic signature.

(5) The application must be made so that it is received by the licensing authority before the beginning of the period of nine months ending with the expiry of the period mentioned in paragraph (1)(a) or (as the case may be) (3)(a) of regulation 65 (initial and further period of validity).

(6) The holder must provide a consolidated version of the file in respect of quality, safety and efficacy, including—

(a)the evaluation of data contained in suspected adverse reaction reports and periodic safety update reports submitted in accordance with Part 11; and

(b)all amendments made since the authorisation was granted.

(7) The licensing authority may renew a UK marketing authorisation only if, having considered the application and the material accompanying it, the authority thinks that the positive therapeutic effects of the product to which the authorisation relates outweigh the risks of the product to the health of patients or of the public.

(8) Schedule 11 makes provision about advice and representations in relation to an application for the renewal of a UK marketing authorisation.

Textual Amendments

F496Reg. 66(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 74 (as amended by (S.I. 2020/1488), reg. 1, Sch. 2 para. 55); 2020 c. 1, Sch. 5 para. 1(1)

[F501Application for renewal of a parallel import licenceU.K.

66A.—(1) The licensing authority may renew a parallel import licence in response to an application made in accordance with this regulation.

(2) The applicant must be established in the [F502United Kingdom].

(3) The application must be—

(a)made in writing;

(b)signed by or on behalf of the applicant; and

(c)unless the licensing authority directs otherwise, accompanied by any fee payable in connection with the application.

(4) An application is treated as signed for the purposes of paragraph (3)(b) if it is signed with an electronic signature.

(5) The application must be made so that it is received by the licensing authority within three months of the end of a period expiring 5 years after the date of grant or (as the case may be) latest renewal of the licence.]

Textual Amendments

[F503Renewal of conditional marketing authorisationU.K.

66B.—(1) The licensing authority may renew a conditional marketing authorisation in relation to an application made to it by the holder of the authorisation.

(2) The application must be made at least six months before the date on which the conditional marketing authorisation is due to expire.

(3) The application must include an interim report on the fulfilment of the obligations to which the conditional marketing authorisation is subject.

(4) When considering an application under paragraph (1), the licensing authority must consider whether—

(a)the positive therapeutic effects of the product continue to outweigh the risks to the health of patients and the public associated with the product; and

(b)the obligations referred to in regulation 59(4C) and any time limits for their fulfilment remain appropriate, modifying or removing them if necessary.

(5) The provisions of regulation 66(2), (3), (4), (6) and (8) apply to an application for renewal of a conditional marketing authorisation.]

Textual Amendments

Failure to place on the market etcU.K.

67.—(1) A UK marketing authorisation ceases to be in force if the product to which it relates is not placed on the market in the United Kingdom F504... during the period of three years beginning immediately after the day on which it was granted.

(2) A UK marketing authorisation for a product which has been placed on the market ceases to be in force if the product to which it relates is not sold or supplied in the United Kingdom F505... for a period of three years.

(3) This regulation does not apply if the licensing authority grants an exemption from its operation.

(4) An exemption may be granted—

(a)in response to an application in writing by the holder of the UK marketing authorisation; or

(b)by the licensing authority of its own motion.

(5) An exemption may be granted only—

(a)in exceptional circumstances; and

(b)on public health grounds.

(6) An exemption—

(a)has effect for the period determined by the licensing authority, which may not exceed three years beginning with the day on which it is granted; and

(b)may be renewed or further renewed.

Textual Amendments

Revocation, variation and suspension of marketing authorisationU.K.

Revocation, variation and suspension of UK marketing authorisation [F506or parallel import licence] U.K.

68.—(1) The licensing authority may revoke, vary or suspend a UK marketing authorisation [F507or parallel import licence] if any of the following conditions is met.

(2) Condition A is that the licensing authority thinks that—

(a)the product to which the authorisation relates is harmful;

(b)the positive therapeutic effects of the product do not outweigh the risks of the product to the health of patients or of the public;

(c)the product lacks therapeutic efficacy, in that therapeutic results cannot be obtained from the product; or

(d)the product's qualitative or quantitative composition is not as described in the application for the authorisation or the material supplied with it.

(3) Condition B is that the licensing authority thinks that the application or the material supplied with it is incorrect.

[F508(4) Condition C is that the licensing authority thinks that there has been a breach of—

(a)a term of the authorisation or licence;

(b)in the case of a UK marketing authorisation, a requirement imposed by Part 13 (packaging and leaflets); or

(c)in the case of a parallel import licence, a requirement in relation to packaging and leaflets imposed by the licensing authority.]

[F509(5) Condition D is that the licensing authority thinks that a condition to which—

(a)the UK marketing authorisation or parallel import licence is subject by virtue of regulation 59 (conditions of UK marketing authorisations or parallel import licence: general); or

(b)the UK marketing authorisation is subject by virtue of regulations 60 (conditions of UK marketing authorisations: exceptional circumstances) [F510, regulation 60A (conditions as to testing of samples by the appropriate authority)] or 61 (conditions of UK marketing authorisations: new obligations post-authorisation),

has not been fulfilled.]

(6) Condition E is that the licensing authority thinks that the holder of the authorisation has not complied with regulation 75(1) to (3) (requirements to provide information).

(7) Condition F is that the holder of the authorisation [F511or licence] has ceased to be [F512established in—

[F513(a)Northern Ireland, in the case of a UKMA(UK)(Category 2) granted under the unfettered access route, and]

[F514(b)the United Kingdom or an EEA State, in any other case,]

in accordance with the requirements of these Regulations.]

(8) Condition G is that—

(a)the product to which the authorisation relates is manufactured in the United Kingdom; and

(b)the licensing authority thinks that the holder of the manufacturer's licence for the product has failed to comply in relation to the product with regulations 37 (manufacturing and assembly), 38 (imports from [F515countries other than approved countries for import]), 39 (further requirements for manufacturer's licence), 40 (obligation to provide information relating to control methods) or 41 (requirements as to qualified persons).

(9) Condition H is that—

(a)the product to which the authorisation relates is manufactured in a member State F516...; and

(b)the licensing authority thinks that the licensee under the manufacturer's licence for the product has failed to comply in relation to the product with provision giving effect to Article 41 of the 2001 Directive (requirements relating to manufacturing authorisations) in that member State.

(10) Condition I is that the licensing authority thinks that urgent action to protect public health is necessary, in which case it—

(a)may suspend the [F517authorisation or licence.]

F518(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(11) Condition J is that—

(a)the holder applies to vary the authorisation [F519or licence]; and

(b)the licensing authority thinks that the application should be granted.

[F520(11A) Condition K is that the manufacture of the product to which the authorisation relates is not carried out in compliance with the particulars provided under paragraphs 5 and 9 of Schedule 8.]

[F521(11B) Condition L is that the licensing authority thinks that the term of the authorisation which specifies the way in which the product is to be made available, as described in regulation 62(1), is incorrect.

(11C) Condition M is that, in respect of a parallel import licence, the UK marketing authorisation in respect of the medicinal product that was specified in the application for that licence under paragraph 4 of Schedule 8A, has been varied, suspended or revoked by the licensing authority under this regulation.

(11D) Condition N is that, in respect of a parallel import licence, the licensing authority is no longer satisfied that the product is essentially similar to a product that has been granted a UK marketing authorisation.

(11E) The licensing authority may not exercise its powers under paragraph (1) by virtue of the condition in paragraph (11D)—

(a)before the end of the period of one year beginning with IP completion day; and

(b)in any event, in a way that prevents the import of any medicinal product in respect of which a qualified person undertook the certification referred to in Article 51(3) of the 2001 Directive before IP completion day.

(11F) Condition O is that the licensing authority thinks that a variation of a UK marketing authorisation is necessary as a result of the submission of the results of a study by the holder of that authorisation under regulation 78A(14).

(11G) Condition P is that the licensing authority thinks that the revocation, variation or suspension is necessary or expedient in light of the Protocol on Ireland/Northern Ireland in the withdrawal agreement.]

[F522(11H) Condition Q is that, in relation to a UKMA(UK)(Category 2), the licensing authority thinks that a variation is necessary in the interest of patients’ health in the United Kingdom so that the authorisation is treated as a UKMA(UK)(Category 1).

(11I) Condition R is that, in relation to a UKMA(UK)(Category 2), the licensing authority thinks that a variation is necessary in the interest of patients’ health in the United Kingdom so that the authorisation is treated as a UKMA(GB) and separate UKMA(NI).

(A12) Where Condition R is met, and the licence holder requests the cancellation of, or fails to renew, either the UKMA(GB) or UKMA(NI) that result from a variation being made under paragraph 11I, the licensing authority may revoke the corresponding UKMA(NI) or UKMA(GB) that results from that variation.]

(12) Schedule 11 makes provision about advice and representations in relation to a proposal to revoke, vary or suspend a UK marketing authorisation [F523or parallel import licence], other than a proposal to vary an authorisation [F524or licence] on the application of its holder.

F525(13) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F506Words in reg. 68 heading inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 68 heading inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(h)

F507Words in reg. 68(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 68(1) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(i)

F512Reg. 68(7)(a)(b) and words substituted for words (31.12.2020) by S.I. 2019/775, reg. 77(3)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 57(a))

Suspension of use etc of relevant medicinal productU.K.

69.—(1) The licensing authority may, if any of the following conditions are met, suspend the use, sale, supply or offer for sale or supply within the United Kingdom of a product to which a UK marketing authorisation [F526or parallel import licence] relates.

(2) Condition A is that the licensing authority thinks that—

(a)the product to which the authorisation relates is harmful;

(b)the positive therapeutic effects of the product do not outweigh the risks of the product to the health of patients or of the public;

(c)the product lacks therapeutic efficacy, in that therapeutic results cannot be obtained from the product; or

(d)the product's qualitative or quantitative composition is not as described in the application for the authorisation or the material supplied with it.

(3) Condition B is that the licensing authority thinks that the holder of the authorisation has not complied with regulation 75(7) (requirements to provide proof of controls on manufacturing process).

(4) Condition C is that the licensing authority thinks that there has been a breach of—

(a)a term of the authorisation; or

(b)a requirement imposed by Part 13 (packaging and leaflets).

(5) Condition D is that the licensing authority thinks that paragraph (4) or (5) of regulation 26 (power to revoke, suspend or vary manufacturers' licences) applies in relation to the manufacturer's licence for the product to which the authorisation relates.

(6) A suspension under this regulation may relate to batches of the product.

(7) The licensing authority must give notice in writing of a suspension under this regulation to the holder of the UK marketing authorisation [F527or parallel import licence].

(8) The licensing authority must provide in the notice that the suspension—

(a)is to take effect immediately or from a date specified in the notice; and

(b)is to apply for the period specified in the notice.

(9) Where a medicinal product is the subject of a suspension under this regulation, the licensing authority may—

(a)in exceptional circumstances; and

(b)for such a transitional period as the licensing authority may determine,

allow the supply of the medicinal product to patients who are already being treated with the medicinal product.

F528(10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F526Words in reg. 69(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 69(1)(7) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(j)

F527Words in reg. 69(7) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 69(1)(7) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(j)

Authorisations granted under Chapter 4 of Title III of the 2001 DirectiveU.K.

F52970.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Withdrawal of medicinal product from the marketU.K.

71.—(1) This regulation applies if—

[F530(a)under regulation 68 the licensing authority revokes or suspends a UK marketing authorisation or parallel import licence; or]

[F531(b)under regulation 69 the licensing authority suspends the use, sale, supply or offer for sale or supply within the United Kingdom of a product to which a UK marketing authorisation relates.]

(2) The licensing authority may give written notice to the person who is, or immediately before its revocation was, the holder of the authorisation [F532or related parallel import licence] requiring that person to comply with both of the following requirements.

(3) Requirement A is to take all reasonably practicable steps to inform wholesalers, retailers, medical practitioners, patients and others who may be in possession of the product to which the authorisation relates of—

(a)the revocation or suspension;

(b)the reasons for the revocation or suspension; and

(c)any action to be taken to restrict or prevent further use, sale, supply or offer for sale or supply of the product.

(4) Requirement B is to take all reasonably practicable steps to withdraw from the market in the United Kingdom and recover possession of—

(a)the product; or

(b)the batches of the product specified in the notice,

within the time and for the period specified in the notice.

Textual Amendments

F532Words in reg. 71(2) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 13 and words in reg. 71(2) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 13

Sale etc of suspended medicinal productU.K.

72.—(1) This regulation applies if the use, sale, supply or offer for sale or supply of a medicinal product is suspended in accordance with [F533regulation 69].

(2) A person must not—

(a)sell, supply or offer to sell or supply the product; or

(b)procure the sale, supply or offer for sale or supply of the product,

knowing, or having reasonable cause to believe, that such use, sale, supply or offer for sale or supply is suspended.

Textual Amendments

Obligations of holder of marketing authorisationU.K.

Obligation to notify placing on the market etcU.K.

73.—(1) The holder of a UK marketing authorisation must notify the licensing authority of the date on which the product to which the authorisation relates is placed on the market in the United Kingdom, taking account of the various presentations authorised.

(2) A notification under paragraph (1) must be given before the end of the period of two months beginning with the date on which the product is placed on the market.

(3) The holder of a UK marketing authorisation must notify the licensing authority if the product to which the authorisation relates is to be withdrawn from the market in the United Kingdom (whether temporarily or permanently).

(4) A notification under paragraph (3) must be given before the beginning of the period of two months ending with the date on which the product is to be withdrawn from the market unless it is not reasonably practicable to do so.

(5) In that event, the notification must be given as far as is reasonably practicable in advance of the date on which the product is withdrawn from the market.

[F534(5A) The holder of a UK marketing authorisation must notify the licensing authority forthwith if the holder takes action to—

(a)request the cancellation of the authorisation;

(b)not apply for the renewal of the authorisation; or

(c)withdraw the product to which the authorisation relates from the market in a [F535country other than the United Kingdom] (whether temporarily or permanently) and the action is based on any of the grounds set out in Article 116 or 117(1) of the 2001 Directive.

(5B) A notification under paragraph (3) or (5A) must include the reasons for the action, in particular declaring if the action is based on any of the grounds set out in Article 116 or 117(1) of the 2001 Directive.

(5C) The holder of a [F536UKMA(NI) or [F537UKMA(UK)(Category 2)]] must also notify the EMA forthwith where the action which is the subject of a notification by the holder under paragraph (3) or (5A) is based on any of the grounds set out in Article 116 or 117(1) of the 2001 Directive.]

(6) The licensing authority may require the holder of a UK marketing authorisation to provide—

(a)information relating to the volume of sales in the United Kingdom of the product to which the authorisation relates; or

(b)information of which the holder is aware relating to the volume of prescriptions in the United Kingdom for the product.

(7) The holder of a UK marketing authorisation must provide the licensing authority with information that it requires under paragraph (6)—

(a)where the period within which the information must be provided is specified in a written notice given to the holder by the licensing authority, before the end of that period; or

(b)otherwise, as soon as is reasonably practicable after receipt of the request.

Textual Amendments

F536Words in reg. 73(5C) substituted (31.12.2020) by virtue of S.I. 2019/775, reg. 82(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 60)

Obligation to take account of scientific and technical progressU.K.

74.—(1) The holder of a UK marketing authorisation must keep under review the methods of manufacture and control of the product to which the authorisation relates, taking account of scientific and technical progress.

(2) As soon as is reasonably practicable after becoming aware of the need to do so, the holder must apply to vary the marketing authorisation to make any changes to those methods that are required to ensure they are generally accepted scientific methods.

[F538Obligation to provide information relating to methods of manufacture and control: MM medicinal productsU.K.

74A.  The holder of a UK marketing authorisation relating to an MM medicinal product must provide the holder of the manufacturer’s licence (MM) relating to that product with information in order to enable the licence holder to ensure that the manufacturer’s licence (MM) and MM master file relating to the product are consistent with the marketing authorisation at all times.

Textual Amendments

Obligation to provide information relating to methods of manufacture and control: POC medicinal productsU.K.

74B.  The holder of a UK marketing authorisation relating to a POC medicinal product must provide the holder of the manufacturer’s licence (POC) relating to that product with information in order to enable the licence holder to ensure that the manufacturer’s licence (POC) and POC master file relating to the product are consistent with the marketing authorisation at all times.]

Textual Amendments

Obligation to provide information relating to safety etcU.K.

75.—(1) The holder of a UK marketing authorisation [F539or parallel import licence] must provide the licensing authority with any new information that might entail the variation of the authorisation.

(2) The holder [F540of a UK marketing authorisation] must, in particular, provide the licensing authority with the following information—

(a)information about any prohibition or restriction imposed in relation to the product to which the authorisation relates by the competent authority of any country in which the product is on the market;

(b)positive and negative results of clinical trials or other studies in all indications and populations, whether or not included in the marketing authorisation;

(c)data on the use of the medicinal product where such use is outside the terms of the marketing authorisation; and

(d)any other information that the holder considers might influence the evaluation of the benefits and risks of the product.

[F541(2A) The holder of a parallel import licence must, in particular, provide the licensing authority with—

(a)information about any prohibition or restriction imposed in relation to the product to which the licence relates by the competent authority of any country in which the product is on the market; and

(b)other information that the holder considers might influence the evaluation of the benefits and risks of the product.]

(3) Information within paragraph (1) [F542to (2A)] must be provided as soon as is reasonably practicable after the holder becomes aware of it.

(4) The licensing authority may require the holder of a UK marketing authorisation to provide the authority with information that—

(a)is specified by the licensing authority; and

(b)demonstrates that the positive therapeutic effects of the product to which the authorisation relates continue to outweigh the risks of the product to the health of patients or of the public.

[F543(4A) The licensing authority may require the holder of a parallel import licence to provide further information specified by the licensing authority.]

(5) The information that may be required under paragraph (4) [F544or (4A)] includes information arising from use of the product—

[F545(a)in a country other than the United Kingdom;]

(b)outside the terms of the [F546UK] marketing authorisation,

including use in clinical trials.

(6) If the information supplied under paragraph (1), (2)[F547, (4) or (4A)] entails the variation of the UK marketing authorisation [F548or parallel import licence], the holder must make an application to the licensing authority to that effect as soon as is reasonably practicable after becoming aware of the information.

(7) The licensing authority may require the holder of a UK marketing authorisation to provide the authority with proof of the control methods employed by the manufacturer of the product to which the authorisation relates.

(8) The holder of a UK marketing authorisation [F549or parallel import licence] must provide the licensing authority with information it requests under paragraphs [F550(4), (4A) or] (7)—

(a)where the period within which the information must be provided is specified in a written notice given to the holder by the licensing authority, before the end of that period; or

(b)otherwise, as soon as is reasonably practicable after receipt of the request.

Textual Amendments

F539Words in reg. 75(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 75(1) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(l)

F542Words in reg. 75(3) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 14(4) and words in reg. 75(3) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 14(4)

F547Words in reg. 75(6) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 14(7) and words in reg. 75(6) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 14(7)

F548Words in reg. 75(6) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 75(6) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(l)

F549Words in reg. 75(8) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 75(8) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(l)

F550Words in reg. 75(8) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 14(8) and words in reg. 75(8) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 14(8)

Obligation in relation to product informationU.K.

76.—(1) The holder of a UK marketing authorisation [F551or parallel import licence] for a medicinal product must ensure that the product information relating to the product is kept up to date with current scientific knowledge.

[F552(2) In this regulation “current scientific knowledge” includes the conclusions of the assessment and recommendations made public by means of—

(a)in the case of a medicinal product authorised for sale or supply by a UKMA(NI) or a [F553UKMA(UK)(Category 2)]—

(i)the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004, and

(ii)the UK web-portal established in accordance with regulation 203(1);

(b)in the case of a medicinal product authorised for sale or supply by a UKMA(GB) [F554or a UKMA(UK)(Category 1)], the UK web-portal established in accordance with regulation 203(1).]

Textual Amendments

F551Words in reg. 76(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 76(1) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(m)

Record-keeping obligationsU.K.

77.  The holder of a marketing authorisation [F555or parallel import licence] must keep any documents or information that will facilitate the withdrawal or recall from sale or supply of any product to which the authorisation relates.

Textual Amendments

Obligation to ensure appropriate and continued suppliesU.K.

78.  The holder of a marketing authorisation must take all reasonable steps to ensure appropriate and continued supplies of the product to which the authorisation relates to pharmacies and persons authorised to supply the product so that the needs of patients in the United Kingdom are met.

[F556Post authorisation requirements in relation to UK marketing authorisations to which paediatric specific provisions applyU.K.

78A.—(1) Paragraph (2) applies where—

(a)a holder of a UK marketing authorisation intends to discontinue supply of the product to which that authorisation relates;

(b)the holder of the authorisation benefited from a reward or incentive under regulation 58A(3) or (8) or 58D(5) in relation to the product; and

(c)the period of protection provided pursuant to those regulations has expired.

(2) Where this paragraph applies, the holder of the UK marketing authorisation must—

(a)either—

(i)transfer the UK marketing authorisation to another person who has declared an intention to continue to supply the product; or

(ii)allow such a person to use the pharmaceutical, pre-clinical and clinical documentation contained in the file on that product in accordance with regulation 56; and

(b)notify the licensing authority of its intention to cease to supply the product before the beginning of the period of six months ending immediately before the day on which the holder does so.

(3) Paragraph (4) applies to the holder of a UK marketing authorisation if—

(a)that authorisation includes a paediatric indication following completion of an agreed paediatric investigation plan; and

(b)the product was placed on the market for other indications before that holder obtained that paediatric indication.

(4) Where this paragraph applies, the holder of the UK marketing authorisation must place the product on the market taking account of the paediatric indication before the end of the period of two years beginning immediately after the day on which the paediatric indication is authorised.

(5) Paragraph (6) applies if—

(a)a decision by the licensing authority in respect of a paediatric investigation plan is addressed to a person (“PIP sponsor”); and

(b)the plan refers to clinical trials carried out in a country other than the United Kingdom (“non-UK clinical trials”).

(6) Where this paragraph applies, the PIP sponsor must send to the licensing authority the details set out in Article 11 of the Clinical Trials Directive in relation to the non-UK clinical trials within whichever is the later of—

(a)the period of one month beginning after the day on which the decision was received; or

(b)the period of one month beginning after the day on which the necessary permission to conduct the clinical trial was received from the competent authorities in the country where the clinical trial is to take place.

(7) Where paragraph (6) applies, the PIP sponsor must submit the results of those clinical trials to the licensing authority within the period of twelve months beginning with the day on which the last of those trials ended, subject to paragraph (8).

(8) Paragraph (7) does not apply in the case of a clinical trial which forms part of a paediatric study to which paragraph (12) applies.

(9) Paragraph (10) applies in relation to the sponsor of a paediatric clinical trial in the United Kingdom in respect of a medicinal product if—

(a)the product has a UK marketing authorisation but the sponsor is not the holder of the authorisation; or

(b)the product does not have a UK marketing authorisation.

(10) Where this paragraph applies, the sponsor of the clinical trial must submit the results of the trial to the licensing authority within the period of twelve months beginning with the day on which the trial ended.

(11) Paragraph (12) applies in relation to the holder of a UK marketing authorisation who sponsors a paediatric clinical trial in respect of the medicinal product to which that authorisation relates.

(12) Where this paragraph applies, the holder of the UK marketing authorisation must submit the results of the trial to the licensing authority within the period of six months beginning with the day on which the trial ended.

(13) Paragraph (14) applies in relation to the holder of a UK marketing authorisation who sponsors a study which involves the use in the paediatric population of a medicinal product to which that UK marketing authorisation relates, irrespective of whether or not—

(a)the studies are conducted in accordance with an agreed paediatric investigation plan; or

(b)the marketing authorisation holder intends to apply for a marketing authorisation for a paediatric indication in relation to the product.

(14) Where this paragraph applies, the holder of the UK marketing authorisation must submit the results of the study to the licensing authority within the period of six months beginning with the day on which the study ended.

(15) Where the licensing authority has granted a deferral of the initiation or completion of some or all of the measures set out in a paediatric investigation plan, in accordance with regulation 50C, the person to whom that decision was addressed must submit to the licensing authority an annual report providing an update on progress with the paediatric studies to which the deferral relates.

(16) The first report referred to in paragraph (15) must be submitted within the period of twelve months beginning with the date on which the licensing authority granted the deferral.

Textual Amendments

Post authorisation requirements in relation to [F557UKMA(UK)(Category 1)] for advanced therapy medicinal productsU.K.

78B.—(1) The holder of a [F558UKMA(UK)(Category 1)] in respect of an advanced therapy medicinal product must—

(a)establish and maintain a system ensuring that the individual product and its starting raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the hospital, institution or private practice where the product is used;

(b)where the product contains human tissues or cells, ensure that the traceability system is complementary to and compatible with requirements imposed pursuant to—

(i)as regards gametes and embryos, sections 12(3), and 33A to 33D of, and paragraph 1 of Schedule 3A to, the Human Fertilisation and Embryology Act 1990,

(ii)as regards blood cells, regulations 8, 9(e) and 14 of the Blood Safety and Quality Regulations 2005, and

(iii)as regards other cells and tissues, regulations 13 and 16 of, and paragraph 1 of Schedule 2 to, the Human Tissue (Quality and Safety for Human Application) Regulations 2007;

(c)keep the data referred to in paragraph (a) for a minimum of 30 years after the expiry of the date of the product, or longer if required by the licensing authority as a term of the [F559UKMA(UK)(Category 1)]; and

(d)in the event of the [F560UKMA(UK)(Category 1)] holder's bankruptcy or liquidation occurring within the period of time for which that holder is required to keep the data referred to in paragraph (a), transfer that data to another person or the licensing authority.

(2) The holder of a [F561UKMA(UK)(Category 1)] who is subject to the obligations in paragraph (1) remains subject to them even if the [F561UKMA(UK)(Category 1)] is suspended or revoked.]

Textual Amendments

Offences relating to specific requirementsU.K.

Failure to provide information on marketing authorisations to EMAU.K.

79.—(1) The holder of [F562a UKMA(NI) or [F563UKMA(UK)(Category 2)]] is guilty of an offence if the holder—

(a)has not submitted information to the EMA as required by Article 57(2)(b) of Regulation (EC) No 726/2004 (information on all existing medicinal products for human use authorised or registered in the EU) in relation to any medicinal product that is the subject of a marketing authorisation granted before 2nd July 2012; and

(b)fails to do so as soon as is reasonably practicable after the coming into force of these Regulations.

(2) The holder of [F564UKMA(NI) or [F565UKMA(UK)(Category 2)]] is guilty of an offence if the holder fails to submit information to the EMA as required by Article 57(2)(c) of Regulation (EC) No 726/2004 (information on any new or varied authorisations granted in the EU) in relation to any medicinal product that is the subject of a marketing authorisation granted on or after 2nd July 2012 as soon as is reasonably practicable after the grant of the authorisation.

Textual Amendments

Urgent safety restrictionsU.K.

80.  The holder of a [F566UK] marketing authorisation is guilty of an offence if the holder —

[F567(a)fails—

(i)in respect of a UKMA(GB) or UKMA(UK), to inform the licensing authority in accordance with paragraph 14(1) of Schedule 10A, or

(ii)in respect of a UKMA(NI) [F568or UKMA(UK)(Category 2)], to inform the European Commission in accordance with Article 22(1) of Regulation (EC) No 1234/2008,

that the holder has taken urgent safety restrictions on the holder’s own initiative;]

[F569(b)fails—

(i)in respect of a UKMA(GB) [F570or UKMA(UK)(Category 2)], to implement an urgent safety restriction imposed on the holder by the licensing authority in accordance with paragraph 14(3) of Schedule 10A, or

(ii)in respect of a UKMA(NI) [F571or UKMA(UK)(Category 2)], to implement an urgent safety restriction imposed on the holder by the European Commission under Article 22(2) of Regulation (EC) No 1234/2008; or]

(c)fails [F572in respect of a UKMA(NI)] to submit an application for variation of the marketing authorisation to the licensing authority or the European Commission in accordance with Article 22(3) of that Regulation before the end of a period of fifteen days beginning on the day after—

(i)the taking under Article 22(1) or, as the case may be,

(ii)the imposition under Article 22(2),

of that Regulation of an urgent safety restriction.

[F573(d)fails in respect of a UKMA(GB) [F574or UKMA(UK)(Category 1)] to submit an application for variation of the UK marketing authorisation to the licensing authority in accordance with paragraph 14(4) of Schedule 10A before the end of the period of fifteen days beginning with the day after—

(i)the taking under paragraph 14(1) of Schedule 10A or, as the case may be,

(ii)the imposition under paragraph 14(3) of that Schedule,

of an urgent safety restriction.]

Textual Amendments

[F575Urgent safety restrictions: parallel import licencesU.K.

80A.  The holder of a parallel import licence is guilty of an offence if the holder—

(a)fails to inform the licensing authority that the holder has taken urgent safety restrictions on the holder’s own initiative;

(b)fails to implement an urgent safety restriction imposed on the holder by the licensing authority; or

(c)fails to submit an application for variation of the parallel import licence to the licensing authority before the end of a period of fifteen days beginning on the day after—

(i)the taking of urgent safety restrictions under paragraph (a) or, as the case may be,

(ii)the imposition of urgent safety restrictions under paragraph (b).]

Textual Amendments

Offences relating to EU marketing authorisationsU.K.

[F576Application of regulations [F57789] to 94U.K.

A81.  Regulations [F57889] to 94 apply in relation to medicinal products for sale or supply in Northern Ireland [F579(that are not in Northern Ireland by virtue of regulation 167A)].]

Textual Amendments

Obligation to update information supplied in connection with EU applicationU.K.

F58081.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

EU marketing authorisations: failure to notify placing on market etcU.K.

F58082.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

EU marketing authorisations: failure to take account of technical and scientific progressU.K.

F58083.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

EU marketing authorisations: failure to provide information as to safety etcU.K.

F58084.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

EU marketing authorisations: failure to update product informationU.K.

F58085.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

EU marketing authorisations: breach of pharmacovigilance condition etcU.K.

F58086.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Offences relating to advanced therapy medicinal productsU.K.

Offences in connection with risk management systems and traceability systemsU.K.

F58087.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Offence concerning data for advanced therapy medicinal productsU.K.

F58088.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Offences relating to the Paediatric RegulationU.K.

Offences in connection with withdrawal of product from the marketU.K.

89.—(1) This regulation applies to a person (“H”) if—

(a)H is the holder of a UK marketing authorisation;

(b)H has benefited from one or more rewards or incentives under [F581Article 37 or 38] of the Paediatric Regulation in relation to the product to which the authorisation relates, and

(c)all of the periods of protection provided pursuant to those Articles have expired in relation to H.

(2) H is guilty of an offence if H ceases to supply the product without previously in accordance with Article 35 of the Paediatric Regulation —

(a)transferring the UK marketing authorisation to another person who has declared an intention to continue to supply the product; or

(b)allowing such a person to use the pharmaceutical, pre-clinical and clinical documentation contained in the file on that product as provided for in regulation 56.

(3) H is guilty of an offence if H—

(a)ceases to supply the product; and

(b)does not in accordance with Article 35 of the Paediatric Regulation inform the EMA of H's intention to do so before the beginning of the period of six months ending immediately before the day on which H does so.

Textual Amendments

Failure to place on the market taking account of paediatric indicationU.K.

90.—(1) A person (“P”) is guilty of an offence if—

(a)P is the holder of a UK marketing authorisation;

(b)P obtains a paediatric indication in respect of the product to which the authorisation relates following completion of an agreed paediatric investigation plan;

(c)the product was placed on the market for other indications before P obtained that paediatric indication; and

(d)P fails to place the product on the market taking account of the paediatric indication in accordance with Article 33 of the Paediatric Regulation before the end of the period of two years beginning immediately after the day on which the paediatric indication is authorised.

(2) In this regulation “paediatric indication” means a term of the marketing authorisation enabling the product to which it relates to be used by or administered to persons under the age of 18 years.

Failure to notify results of third country clinical trialsU.K.

F58291.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Failure of sponsor of UK paediatric clinical trial to notify results of trialU.K.

92.—(1) This regulation applies to the sponsor (“S”) of a paediatric clinical trial in the United Kingdom in respect of a medicinal product if—

(a)the product has a UK marketing authorisation but S is not the holder of the authorisation; or

(b)the product does not have a marketing authorisation.

(2) S is guilty of an offence if S does not submit the results of the clinical trial to the EMA in accordance with Article 41(2) of the Paediatric Regulation within the period of twelve months beginning with the day on which the trial ended.

Failure to notify results of paediatric studyU.K.

93.—(1) This regulation applies to a person (“H”) if—

(a)H is the holder of a UK marketing authorisation; and

(b)H sponsors a paediatric study in respect of the product to which the authorisation relates.

(2) H is guilty of an offence if H does not submit the results of the study to the licensing authority in accordance with Article 46(1) of the Paediatric Regulation within the period of six months beginning with the day on which the study ended.

(3) H is guilty of an offence if H does not submit the results of any clinical trial that forms part of that study to the EMA in accordance with Article 41(2) of the Paediatric Regulation within the period of six months beginning with the day on which the trial ended.

Failure to submit report to EMAU.K.

94.  The holder of a marketing authorisation is guilty of an offence if the holder fails to submit an annual report to the EMA as required by Article 34(4) of the Paediatric Regulation.

[F583Offences relating to the safety features appearing on the packaging of medicinal products]U.K.

Textual Amendments

F583Reg. 94A and cross-heading inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 8 and reg. 94A and cross-heading inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 8

Offences relating to Commission Regulation 2016/161U.K.

F58494A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

General provisions relating to offencesU.K.

Offences in connection with applicationU.K.

95.  A person is guilty of an offence if, in the course of an application for the grant, renewal or variation of a marketing authorisation for a relevant medicinal product, the person—

(a)fails to provide the licensing authority with any information that is relevant to the evaluation of the safety, quality or efficacy of the product; [F585or]

(b)provides to the licensing authority any information that is relevant to the evaluation of the safety, quality or efficacy of the product but that is false or misleading in a material particular;

F586(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F587(d). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F588Offences in connection with parallel import licence applicationU.K.

95A.  A person is guilty of an offence if, in the course of an application for the grant, renewal or variation of a parallel import licence for a relevant medicinal product, the person—

(a)fails to provide the licensing authority with any information that is relevant to the evaluation of the safety, quality or efficacy of the product; or

(b)provides to the licensing authority any information that is relevant to the evaluation of the safety, quality or efficacy of the product but that is false or misleading in a material particular.]

Textual Amendments

Provision of false or misleading informationU.K.

96.—(1) The holder of a marketing authorisation [F589or parallel import licence] is guilty of an offence if the holder provides any information to which paragraph (2) applies that is relevant to the evaluation of the safety, quality or efficacy of a medicinal product but that is false or misleading in a material particular to—

(a)the licensing authority;

(b)the EMA; or

(c)the competent authorities of other EEA States.

(2) This paragraph applies to information about the product that is supplied pursuant to the obligations in—

(a)these Regulations; or

(b)Regulation (EC) No 726/2004.

(3) This regulation is without prejudice to the operation of regulation 95.

Textual Amendments

F589Words in reg. 96(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 96(1) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(o)

Breach of pharmacovigilance conditionU.K.

[F59097.—(1) The holder of a marketing authorisation or a parallel import licence is guilty of an offence if the holder fails to comply with a condition to which the marketing authorisation or parallel import licence is subject by virtue of regulation 59 (conditions of a UK marketing authorisation or parallel import licence: general).

(2) The holder of a marketing authorisation is guilty of an offence if the holder fails to comply with a condition to which the marketing authorisation is subject by virtue of regulation 60 (conditions of a UK marketing authorisation: exceptional circumstances) [F591, regulation 60A (condition as to the testing of samples by the appropriate authority)] or 61 (conditions of a UK marketing authorisation: new obligations post-authorisation).]

Textual Amendments

General offence of breach of provision of this PartU.K.

98.—(1) A person is guilty of an offence if that person commits a breach of a provision in this Part.

(2) A breach of a provision in this Part includes any—

(a)failure by the holder of a marketing authorisation [F592or parallel import licence] to comply with any requirement or obligation in this Part:

(b)contravention by any person of any prohibition in this Part; or

(c)failure to comply with any requirement imposed on a person by the licensing authority pursuant to this Part.

(3) Paragraph (1) is without prejudice to any offence established by any other provision in this Part.

Textual Amendments

F592Words in reg. 98(2)(a) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 98(2)(a) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(p)

PenaltiesU.K.

99.—(1) A person guilty of an offence under this Part, other than a breach of regulation 79 (failure to provide information on marketing authorisations to EMA), is liable—

(a)on summary conviction, to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment, to a fine, to imprisonment for a term not exceeding two years or to both.

(2) A person guilty of a breach of regulation 79 is liable—

(a)on summary conviction, to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment, to a fine.

Persons liableU.K.

100.  If a breach of regulation 95 (offences in connection with application) is committed by a person acting as employee or agent, the employer or principal of that person is guilty of the same offence and is liable to be proceeded against and punished accordingly.

DefencesU.K.

101.—(1) Paragraph (2) applies if the holder of a marketing authorisation [F593or parallel import licence] is charged with an offence under this Part in respect of anything that—

(a)has been manufactured or assembled to the holder's order by another person; and

(b)has been so manufactured or assembled as not to comply with the terms of the authorisation.

(2) It is a defence for the holder to prove that—

(a)the holder communicated the terms of the authorisation to the other person; and

(b)the holder did not know and could not by the exercise of reasonable care have known that those terms had not been complied with.

(3) It is a defence for a person charged with an offence consisting of a breach of regulations 73(3) or 78, or an offence under any of regulations [F59489] to 93, 95 and 96, to prove that the person took all reasonable precautions and exercised all due diligence to avoid commission of that offence.

(4) Where evidence is adduced that is sufficient to raise an issue with respect to the defence in paragraph (3), the court or jury must presume that the defence is satisfied unless the prosecution proves beyond reasonable doubt that it is not.

Textual Amendments

F593Words in reg. 101(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 101(1) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(q)

PART 6U.K.Certification of homoeopathic medicinal products

Application of PartU.K.

Application of PartU.K.

102.—(1) This Part applies to a homoeopathic medicinal product (a “registrable homoeopathic medicinal product”) that meets the following conditions.

(2) Condition A is that the product is administered orally or externally.

(3) Condition B is that no specific therapeutic indication appears—

(a)on the labelling of the product; or

(b)in any information supplied with the product.

(4) Condition C is that—

(a)the product contains no more than one part per 10,000 of the mother tincture; and

(b)in a case where the product's active substance is a relevant allopathic substance, the product contains no more than 1/100th of the smallest concentration of that substance used in allopathy.

(5) In this regulation “relevant allopathic substance” means an active substance whose presence in an allopathic medicinal product means that the product is only available on prescription.

(6) For this purpose—

(a)“allopathic medicinal product” means a medicinal product other than a homoeopathic medicinal product; and

(b)“allopathy” means treatment using an allopathic medicinal product.

[F595( 7) The Secretary of State may make regulations in respect of Great Britain to amend paragraphs (4) to (6).

(8) The Secretary of State may only exercise the power in paragraph (7) if the Secretary of State considers that it is necessary to do so because of new scientific evidence.]

Textual Amendments

Application for certificate of registration and consideration of applicationU.K.

Application for certificate of registrationU.K.

103.—(1) The licensing authority may, subject to regulation 104, grant an application for a certificate of registration for a registrable homoeopathic medicinal product in response to an application made in accordance with this Part.

[F596(1A) The licensing authority may accept an application meeting reduced or alternative requirements specified in this Part (“under the unfettered access route”) and grant a COR(GB) only where—

(a)there is already in place, or will be at the time the COR(GB) is granted, a certificate of registration in respect of the product authorising sale or supply in Northern Ireland,

(b)the applicant complies with the requirements in paragraph (5B), and

(c)the registrable homoeopathic medicinal product satisfies the definition of qualifying Northern Ireland goods.

(1B) A certificate of registration must state whether it is in force in—

(a)the whole United Kingdom;

(b)Great Britain only; or

(c)Northern Ireland only,

and in these Regulations the meaning of a reference to that certificate of registration being “in force” is limited to that territory.]

(2) A certificate granted under paragraph (1) shall contain terms approved by the licensing authority.

(3) The application may relate to two or more homoeopathic medicinal products derived from the same homoeopathic stock or the same combination of homoeopathic stocks.

(4) The applicant [F597where it is applying for—

(a)a COR(NI)—

(i)in accordance with Chapter 4 of Title III of the 2001 Directive, must be established in the European Union;

(ii)on any other basis, must be established in the United Kingdom;

(b)a COR(GB)—

(i)under the unfettered access route, must be established in Northern Ireland;

(ii)other than under the unfettered access route, must be established in the United Kingdom;

(c)a COR(UK), must be established in the United Kingdom.]

(5) The application must be—

(a)made in writing;

(b)signed by or on behalf of the applicant; and

(c)unless the licensing authority directs otherwise, accompanied by any fee payable in connection with the application.

[F598(5A) The application must include a statement indicating whether the certificate sought is for sale or supply of the product in—

(a)the whole United Kingdom;

(b)Great Britain only; or

(c)Northern Ireland only.

(5B) The applicant for the grant of a COR(GB) under the unfettered access route must provide—

(a)the application form submitted in connection with the granting of the COR(NI) which authorises the sale or supply of the product in Northern Ireland;

(b)a copy of all material submitted in support of the application for the COR(NI) which authorises the sale or supply of the product in Northern Ireland; and

(c)a copy of the COR(NI) which authorises the sale or supply of the medicinal product in Northern Ireland,

together with any material specified in paragraph (8) which is not included in the material specified in sub-paragraphs (a) to (c) in relation to the product.]

(6) An application is treated as signed for the purposes of paragraph (5)(b) if it is signed with an electronic signature.

(7) The application and any accompanying material must be in English.

(8) The applicant must provide each of the following for each product to which the application relates—

(a)a statement of the scientific name, or other name given in a pharmacopoeia, of the homoeopathic stock or stocks from which the product is derived;

(b)a statement of the routes of administration, pharmaceutical forms and degree of dilution of the product;

(c)a dossier describing how the homoeopathic stock or stocks are obtained and controlled and justifying their homoeopathic use on the basis of an adequate bibliography;

(d)a manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentisation of the product;

(e)evidence that each manufacturer of the medicinal product is authorised to manufacture it (which, in the case of a product manufactured in the United Kingdom F599..., means the manufacturer's licence or (as the case may be) its equivalent in [F600a country other than the United Kingdom]);

(f)where an authorisation to place the product on the market has been granted by [F601a country other than the United Kingdom], a copy of the authorisation;

(g)a mock-up of the outer and immediate packaging of the product; and

(h)data concerning the stability of the product.

(9) This material, taken as a whole, must be such as to demonstrate the pharmaceutical quality and batch to batch homogeneity of each product to which the application relates.

(10) The applicant must also, if requested by the licensing authority to do so, provide the licensing authority with material or information that the licensing authority reasonably considers necessary for considering the application.

Textual Amendments

Consideration of applicationU.K.

104.—(1) The licensing authority must take all reasonable steps to ensure that it makes a decision to grant or refuse a certificate of registration before the end of the period of 210 days beginning immediately after the day on which an application for the certificate is submitted in accordance with regulation 103.

(2) If the licensing authority requests the applicant to provide any further information or material, the period referred to in paragraph (1) is suspended for the period—

(a)beginning with the date on which the request is made; and

(b)ending with the date on which the information or material is provided.

(3) The licensing authority may grant a certificate only if, having considered the application and the accompanying material, the authority thinks that—

(a)the risks to the health of patients or of the public associated with the product do not outweigh any beneficial effects of the homoeopathic medicinal product in question;

(b)the application and the accompanying material complies with regulation 103; and

(c)the product's qualitative or quantitative composition is as described in the application and the accompanying material.

(4) Schedule 11 makes provision about advice and representations in relation to an application for the grant of a certificate of registration.

(5) This regulation does not apply to an application that—

(a)has been submitted to the licensing authority in accordance with Article 28 of the 2001 Directive; or

(b)has been referred to the Committee for Medicinal Products for Human Use for the application of the procedure laid down in Articles 32 to 34 of the 2001 Directive.

(6) An application to which paragraph (5) applies is to be determined by the licensing authority in accordance with Chapter 4 of Title III of the 2001 Directive.

[F602(7) In the case of an application under the unfettered access route, the licensing authority may grant a COR(GB) (notwithstanding paragraph (3)) where the licensing authority—

(a)has considered the application under the unfettered access route and the accompanying material,

(b)is satisfied that the applicant has complied with the application requirements, and

(c)is satisfied that the conditions in regulation 103(1A) will continue to be met.

(8) The licensing authority may refuse to grant an application under the unfettered access route where it is of the opinion that it would represent a risk to public health to do so.]

Textual Amendments

Conditions of certificate of registrationU.K.

105.—(1) The licensing authority may—

(a)grant a certificate of registration subject to conditions; or

(b)vary or remove a condition to which the certificate of registration is subject.

(2) The powers in paragraph (1) may be exercised only after consultation with the applicant for the certificate or (as the case may be) its holder.

(3) The power in paragraph (1)(a) to grant an authorisation subject to conditions may be exercised only—

(a)in exceptional circumstances; and

(b)when the applicant can show that the applicant is unable to provide comprehensive data on the safety of the medicinal product under normal conditions of use.

(4) The conditions must relate to a matter addressed by Annex I to the 2001 Directive.

(5) The conditions may, in particular, relate to the safety of the product to which the certificate relates.

(6) The conditions may, in particular, require that, where there is an incident relating to the use of the product—

(a)the incident must be reported to the licensing authority; and

(b)such other action as may be specified in the conditions must be taken.

(7) The licensing authority must keep under review—

(a)the conditions to which a certificate of registration is subject; and

(b)the holder's compliance with those conditions.

(8) The licensing authority must consider those matters no less frequently than—

(a)at the end of the period of one year beginning with the date on which the certificate was granted; and

(b)at the end of each subsequent period of one year.

(9) Schedule 11 makes provision about advice and representations in relation to proposals to vary or remove a condition to which a certificate of registration is subject.

Classification of certificate of registrationU.K.

106.—(1) A certificate of registration must include a term that the product to which the certificate relates is to be available—

(a)only from a pharmacy; or

(b)on general sale.

(2) A certificate of registration may include a term that the product to which the certificate relates is to be available on general sale only if the licensing authority considers that the product can with reasonable safety be sold or supplied otherwise than by, or under the supervision of, a pharmacist [F603or by a person who acts in accordance with regulation 220A or 220B (or an exemption in Chapter 3 of Part 12)].

Textual Amendments

Validity of certificate of registrationU.K.

107.—(1) Subject to the following paragraphs, a certificate of registration remains in force—

(a)for an initial period of five years beginning with the date on which it is granted; and

(b)if the authorisation is renewed under regulation 108 for an unlimited period after its renewal.

(2) The licensing authority may, on the first application for renewal of a certificate, determine on grounds relating to pharmacovigilance, including exposure of an insufficient number of patients to the medicinal product concerned, that it should be necessary for the holder to make one further application for renewal.

(3) In that event, the certificate remains in force—

(a)for a further period of five years beginning with the date on which it is first renewed; and

(b)if the authorisation is further renewed under regulation 108 for an unlimited period after its further renewal.

(4) If an application for the renewal or further renewal of a certificate is made in accordance with regulation 108 the certificate remains in force until the licensing authority notifies the applicant of its decision on the application.

(5) This regulation is subject to—

(a)regulation 109 (failure to place on the market etc); and

(b)regulation 110 (revocation etc of certificate of registration).

Application for renewal of certificateU.K.

108.—(1) An application for the renewal of a certificate of registration must be made to the licensing authority.

(2) The applicant [F604, where it is applying for renewal of—

(a)a COR(NI) and originally granted—

(i)in accordance with Chapter 4 of Title III of the 2001 Directive, must be established in the European Union;

(ii)on any other basis, must be established in the United Kingdom;

(b)a COR(GB) and originally granted—

(i)under the unfettered access route, must be established in Northern Ireland;

(ii)other than under the unfettered access route, must be established in the United Kingdom;

(c)in the whole United Kingdom, must be established in the United Kingdom.]

(3) The application must be—

(a)made in writing;

(b)signed by or on behalf of the applicant; and

(c)unless the licensing authority directs otherwise, accompanied by any fee payable in connection with the application.

(4) An application is treated as signed for the purposes of paragraph (3)(b) if it is signed with an electronic signature.

(5) The application must be made so that it is received by the licensing authority before the beginning of the period of nine months ending with the expiry of the period mentioned in paragraph (1)(a) or (as the case may be) (3)(a) of regulation 107 (initial and further period of validity).

(6) The holder must provide a consolidated version of the file in respect of quality, safety and efficacy (including all amendments made since the authorisation was granted).

(7) The licensing authority may renew a certificate only if, having considered the application and the material accompanying it, the authority thinks that the risks to the health of patients or of the public associated with the homoeopathic medicinal product to which the certificate relates do not outweigh any beneficial effects of the product.

(8) Schedule 11 makes provision about advice and representations in relation to an application for the renewal of a certificate of registration.

Textual Amendments

Failure to place on the market etcU.K.

109.—(1) A certificate of registration ceases to be in force if the product to which it relates is not placed on the market in the United Kingdom [F605(or, in the case of a COR(GB) granted after an application under the unfettered access route, in Great Britain)] during the period of three years beginning immediately after the day on which it was granted.

(2) A certificate of registration for a product which has been placed on the market ceases to be in force if the product to which it relates is not sold or supplied in the United Kingdom [F606(or, in the case of a COR(GB) granted after an application under the unfettered access route, in Great Britain)] for a period of three years.

(3) This regulation does not apply if the licensing authority grants an exemption from its operation.

(4) An exemption may be granted—

(a)in response to an application in writing by the holder of the certificate of registration; or

(b)by the licensing authority of its own motion.

(5) An exemption may be granted only—

(a)in exceptional circumstances; and

(b)on public health grounds.

(6) An exemption—

(a)has effect for the period determined by the licensing authority, which may not exceed three years beginning with the day on which it is granted; and

(b)may be renewed or further renewed.

Textual Amendments

Revocation, variation and suspension of certificate of registrationU.K.

Revocation, variation and suspension of certificate of registrationU.K.

110.—(1) The licensing authority may revoke, vary or suspend a certificate of registration if any of the following conditions are met.

(2) Condition A is that the licensing authority thinks that—

(a)the product to which the certificate relates is harmful;

(b)the risks of the product to the health of patients or of the public outweigh any beneficial effects of the product; or

(c)the product's qualitative or quantitative composition is not as described in the application for the certificate or the material supplied with it.

(3) Condition B is that the licensing authority thinks that the application or the material accompanying it is incorrect.

(4) Condition C is that the licensing authority thinks that there has been a breach of—

(a)a term of the certificate; or

(b)a requirement imposed by Chapter 1 of Part 13 (packaging and leaflets).

(5) Condition D is that the licensing authority thinks that a condition to which the certificate is subject by virtue of regulation 105 (conditions of certificate or registration) has not been fulfilled.

(6) Condition E is that the licensing authority thinks that the holder of the certificate has not complied with regulation 115(1) to (3) (requirements to provide information).

(7) Condition F is that the holder of the certificate has ceased to be [F607established in—

(a)the United Kingdom; or

(b)in relation to a COR(NI), either the United Kingdom or the European Union,

in accordance with the requirements of these Regulations.]

(8) Condition G is that—

(a)the holder applies to vary the certificate; and

(b)the licensing authority thinks that the application should be granted.

[F608(8A) Condition H is that the manufacture and control of the product to which the certificate relates is not in compliance with the particulars provided under regulation 103(8)(c) and (d).]

[F609(8B) Condition I is that the licensing authority thinks that the revocation, variation or suspension is necessary or expedient in light of the Protocol on Ireland/Northern Ireland in the withdrawal agreement.]

(9) Schedule 11 makes provision about advice and representations in relation to a proposal to revoke, vary or suspend a certificate of registration, other than a proposal to vary a certificate on the application of its holder.

(10) This regulation is subject to regulation 111 (certificates granted under Chapter 4 of Title III of the 2001 Directive).

Textual Amendments

F607Reg. 110(7)(a)(b) substituted for words in reg. 110(7) (31.12.2020) by S.I. 2019/775, reg. 102(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 80(a))

Certificates granted under Chapter 4 of Title III of the 2001 DirectiveU.K.

F610111.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Withdrawal of homoeopathic medicinal product from the marketU.K.

112.—(1) This regulation applies if under regulation 110 F611... the licensing authority revokes or suspends a certificate of registration.

(2) The licensing authority may give written notice to the person who is, or immediately before its revocation was, the holder of the certificate requiring the holder to comply with the following requirement.

(3) That requirement is to take all reasonably practicable steps to withdraw from the market in the United Kingdom and recover possession of—

(a)the product to which the certificate relates; or

(b)the batches of the product specified in the notice,

within the time and for the period specified in the notice.

(4) The notice must specify the grounds for giving the notice.

Textual Amendments

Obligations of holder of certificate of registrationU.K.

Obligation to notify placing on the market etcU.K.

113.—(1) The holder of a certificate of registration must notify the licensing authority of the date on which the product to which the certificate relates is placed on the market in the United Kingdom taking account of the various presentations authorised.

(2) A notification under paragraph (1) must be given before the end of the period of two months beginning with the date on which the product is placed on the market.

(3) The holder of a certificate of registration must notify the licensing authority if the product to which the certificate relates is to be withdrawn from the market in the United Kingdom (whether temporarily or permanently).

[F612(3A) A notification under paragraph (3) must include the reasons for the withdrawal F613....]

(4) A notification under paragraph (3) must be given before the beginning of the period of two months ending with the date on which the product is to be withdrawn from the market unless it is not reasonably practicable to do so.

(5) In that event, the notification must be given as far as is reasonably practicable in advance of the date on which the product is withdrawn from the market.

(6) The licensing authority may require the holder of a certificate of registration to provide information relating to the volume of sales in the United Kingdom of the product to which the certificate relates.

(7) The holder of a certificate of registration must provide the licensing authority with information that it requires under paragraph (6)—

(a)where the period within which the information must be provided is specified in a written notice given to the holder by the licensing authority, before the end of that period; or

(b)otherwise, as soon as is reasonably practicable after receipt of the request.

Textual Amendments

Obligation to take account of scientific and technical progressU.K.

114.—(1) The holder of a certificate of registration must keep under review the methods of manufacture and control of the product to which the certificate relates, taking account of scientific and technical progress.

(2) As soon as is reasonably practicable after becoming aware of the need to do so, the holder must apply to vary the certificate of registration to make any changes to those methods that are required to ensure they are generally accepted scientific methods.

Obligation to provide information relating to safety etcU.K.

115.—(1) The holder of a certificate of registration must provide the licensing authority with any new information that might entail the variation of the certificate.

(2) The holder must, in particular, provide the licensing authority with the following information—

(a)information about any prohibition or restriction imposed in relation to the product to which the certificate relates by the competent authority of any country in which the product is on the market;

(b)positive and negative results of clinical trials or other studies in all indications and populations, whether or not included in the certificate of registration;

(c)data on the use of the product where such use is outside the terms of the certificate of registration; and

(d)any other information that the holder considers might influence the evaluation of the benefits and risks of the product.

(3) Information within paragraph (1) or (2) must be provided as soon as is reasonably practicable after the holder becomes aware of it.

(4) The licensing authority may require the holder of a certificate of registration to provide the authority with information that—

(a)is specified by the licensing authority; and

(b)demonstrates that the risks of the product to the health of patients or of the public do not outweigh any beneficial effects of the product to which the certificate relates.

(5) The information that may be required under paragraph (4) includes information arising from use of the product—

(a)in a country [F614other than the United Kingdom]; or

(b)outside the terms of the certificate of registration.

(6) If the information supplied under paragraph (1), (2) or (4) entails the variation of the certificate of registration, the holder must make an application to the licensing authority to that effect as soon as is reasonably practicable after becoming aware of the information.

(7) The licensing authority may require the holder of a certificate of registration to provide the authority with proof of the control methods employed by the manufacturer of the product to which the certificate relates.

(8) The licensing authority may notify the holder of a certificate of registration that it requires the holder to provide to the licensing authority information of any description specified in the notice, within the period specified in the notice, subject to paragraph (9).

(9) A notice under paragraph (8) must not be served unless it appears to the licensing authority, or it is represented to the licensing authority by the Commission or by an expert committee appointed by the licensing authority—

(a)that circumstances exist by reason of which it is necessary to consider whether the certificate of registration should be varied, suspended or revoked; and

(b)that the information required by the notice is needed to consider that question.

(10) The holder of a certificate of registration must provide the licensing authority with information that it requires under paragraphs (4) or (7)—

(a)where the period within which the information must be provided is specified in a written notice given to the holder by the licensing authority, before the end of that period; or

(b)otherwise, as soon as is reasonably practicable after receipt of the request.

Textual Amendments

Obligation in relation to product informationU.K.

116.—(1) The holder of the certificate of registration for a medicinal product must ensure that the product information relating to the product is kept up to date with current scientific knowledge.

[F615(2) In this regulation “current scientific knowledge” includes the conclusions of the assessment and recommendations made public by means of—

(a)in the case of a medicinal product authorised by a COR(NI) or COR(UK)—

(i)the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004, and

(ii)the UK web-portal established in accordance with regulation 203(1);

(b)in the case of a medicinal product authorised by a COR(GB), the UK web-portal established in accordance with regulation 203(1).]

Textual Amendments

Record-keeping obligationU.K.

117.  The holder of a certificate of registration must keep any documents or information that will facilitate the withdrawal or recall from sale or supply of the product to which the certificate relates.

Obligation to ensure appropriate and continued suppliesU.K.

118.  The holder of a certificate of registration must take all reasonable steps to ensure appropriate and continued supplies of the product to which the certificate relates to pharmacies and persons authorised to supply the product so that the needs of patients in the United Kingdom are met.

Provisions relating to offencesU.K.

Offences in connection with applicationsU.K.

119.  A person is guilty of an offence if, in the course of an application for the grant, renewal or variation of a certificate of registration for a registrable homoeopathic medicinal product, the person—

(a)fails to provide the licensing authority with any information that is relevant to an evaluation of the quality of the product; or

(b)provides to the licensing authority any information that is relevant to an evaluation of the quality of the product that is false or misleading in a material particular.

Provision of false or misleading informationU.K.

120.—(1) The holder of a certificate of registration for a medicinal product is guilty of an offence if the person provides the licensing authority with any information that is relevant to the quality of the product but that is false or misleading in a material particular.

(2) Paragraph (1) is without prejudice to the operation of regulation 119.

General offence of breach of provision of this PartU.K.

121.—(1) A person is guilty of an offence if that person commits a breach of a provision in this Part.

(2) A breach of a provision in this Part includes any—

(a)failure by the holder of a certificate of registration to comply with any requirement or obligation in this Part;

(b)contravention by any person of any prohibition in this Part; or

(c)failure to comply with any requirement imposed on a person by the licensing authority pursuant to this Part.

(3) Paragraph (1) is without prejudice to any offence established by any other provision in this Part.

PenaltiesU.K.

122.  A person guilty of an offence under this Part is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment, to a fine, to imprisonment for a term not exceeding two years or to both.

Persons liableU.K.

123.  If an offence under regulation 119 (offences in connection with applications) is committed by a person acting as employee or agent, the employer or principal of that person is guilty of the same offence and is liable to be proceeded against and punished accordingly.

DefencesU.K.

124.—(1) Paragraph (2) applies if the holder of a certificate of registration is charged with an offence under this Part in respect of anything that—

(a)has been manufactured or assembled to the holder's order by another person; and

(b)has been so manufactured or assembled as not to comply with the terms of the certificate.

(2) It is a defence for the holder to prove that—

(a)the holder communicated the terms of the certificate to the other person; and

(b)the holder did not know and could not by the exercise of reasonable care have known that those terms had not been complied with.

(3) It is a defence for a person charged with an offence consisting of a breach of regulation 113(3) or 118 or an offence under regulation 119 or 120 to prove that the person took all reasonable precautions and exercised all due diligence to avoid commission of that offence.

(4) Where evidence is adduced that is sufficient to raise an issue with respect to the defence in paragraph (3), the court or jury must presume that the defence is satisfied unless the prosecution proves beyond reasonable doubt that it is not.

PART 7U.K.Traditional herbal registrations

[F616Interpretation and application of Part]U.K.

Textual Amendments

[F617Interpretation of this PartU.K.

124A.  In this Part, “relevant list” means—

(a)the list referred to in Article 16f(1) of the 2001 Directive, as that list may be amended from time to time; or

(b)if the licensing authority publishes a list under regulation 126A(1), that list.]

Textual Amendments

Traditional herbal medicinal productsU.K.

125.—(1) This Part applies to a herbal medicinal product (a “traditional herbal medicinal product”) if the following conditions are met.

(2) Condition A is met if by virtue of its composition and indications the product is appropriate for use without the need for a medical practitioner to—

(a)diagnose the condition to be treated by the product;

(b)prescribe the product; or

(c)monitor the product's use.

(3) Condition B is met if the product is intended to be administered at a particular strength and in accordance with a particular posology.

(4) Condition C is met if the product is intended to be administered externally, orally or by inhalation.

(5) Condition D is met if—

(a)the product has been in medicinal use for a continuous period of at least 30 years, and

[F618(b)in relation to—

(i)a THR(NI) or THR(UK), the product has been in medicinal use in the European Union for a continuous period of at least 15 years;

(ii)a THR(GB), the product has been in medicinal use in the United Kingdom or a country included in the list published under regulation 125A(1) for a continuous period of at least 15 years.]

(6) It is immaterial for the purposes of condition D whether or not during a period mentioned in that condition—

(a)the sale or supply of the product has been based on a specific authorisation; or

(b)the number or quantity of the ingredients (or any of them) has been reduced.

(7) Condition E is met if there is sufficient information about the use of the product as mentioned in condition D (referred to in this Part as its “traditional use”), so that (in particular)—

(a)it has been established that the traditional use of the product is not harmful; and

(b)the pharmacological effects or efficacy of the product are plausible on the basis of long-standing use and experience.

Textual Amendments

[F619List of approved countries for traditional use of a herbal medicinal productU.K.

125A.—(1) The licensing authority may publish a list of countries for the purposes of regulation 125(5)(b) (condition D).

(2) In establishing the list under paragraph (1), the licensing authority may only include a country in that list if it is satisfied that—

(a)continuous use evidence in respect of that country can be sufficiently validated by the licensing authority; and

(b)the country has a level of pharmacovigilance that is equivalent to that in the United Kingdom to ensure that any safety issues in respect of the herbal medicinal product have been properly identified.

(3) The licensing authority must—

(a)review any list it publishes under paragraph (1) to determine if a country still satisfies the criteria for inclusion in the list specified in paragraph (2), and if it is not so satisfied, remove that country from the list; and

(b)undertake such a review at least every three years beginning with the date on which the country is included in that list.]

Textual Amendments

Addition of vitamins or mineralsU.K.

126.  The addition to a traditional herbal medicinal product of a vitamin or mineral does not prevent a traditional herbal registration from being granted for the product if—

(a)there is well-documented evidence of the safety of the vitamin or mineral; and

(b)the action of the vitamin or mineral is ancillary to the action of the product's active herbal ingredients in connection with the use authorised by the traditional herbal registration.

[F620List of herbal substances, preparations and combinations for use in traditional herbal medicinal productsU.K.

Textual Amendments

Licensing authority list as to herbal substances, preparations and combinations for use in traditional herbal medicinal productsU.K.

126A.—(1) The licensing authority may establish, and publish a list of, herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products for which a THR(GB) may be granted.

(2) A list established under paragraph (1) must contain, with regard to each herbal substance—

(a)the indication;

(b)the specified strength and posology;

(c)the route of administration; and

(d)any other information necessary for the safe use of the herbal substance as a traditional medicinal product.

(3) The licensing authority may review and amend any list it publishes under paragraph (1) at such intervals as it considers appropriate.]

Application for traditional herbal registrationU.K.

Application for grant of traditional herbal registrationU.K.

127.—(1) The licensing authority may, subject to regulation 130, grant an application for a traditional herbal registration for a traditional herbal medicinal product in response to an application made in accordance with this Part.

[F621(1A) The licensing authority may accept an application meeting reduced or alternative requirements specified in this Part (“under the unfettered access route”) and grant a THR(GB) only where—

(a)there is already in place, or will be at the time the THR(GB) is granted, a traditional herbal registration in respect of the product authorising sale or supply in Northern Ireland,

(b)the applicant complies with the requirements in regulation 128(1A), and

(c)the traditional herbal medicinal product satisfies the definition of qualifying Northern Ireland goods.

(1B) A traditional herbal registration must state whether it is in force in—

(a)the whole United Kingdom;

(b)Great Britain only; or

(c)Northern Ireland only,

and in these Regulations the meaning of a reference to that traditional herbal registration being “in force” is limited to that territory.]

(2) A registration granted under paragraph (1) shall contain terms approved by the licensing authority.

(3) The applicant [F622, where it is applying for—

(a)a THR(NI)—

(i)in accordance with Chapter 4 of Title III of the 2001 Directive, must be established in the European Union;

(ii)on any other basis, must be established in the United Kingdom;

(b)a THR (GB)—

(i)under the unfettered access route, must be established in Northern Ireland;

(ii)other than under the unfettered access route, must be established in the United Kingdom;

(c)a THR(UK), must be established in the United Kingdom.]

(4) The application must be—

(a)made in writing;

(b)signed by or on behalf of the applicant; and

(c)unless the licensing authority directs otherwise, accompanied by any fee payable in connection with the application.

[F623(4A) The application must include a statement indicating whether the traditional herbal registration sought is for sale or supply of the product in—

(a)the whole United Kingdom;

(b)Great Britain only; or

(c)Northern Ireland only.]

(5) An application is treated as signed for the purposes of paragraph (4)(b) if it is signed with an electronic signature.

(6) The application and any accompanying material must be in English.

(7) The application must include a statement indicating whether the product to which the application relates should be available—

(a)only from a pharmacy; or

(b)on general sale.

(8) The application must include a statement indicating—

(a)whether any terms of the registration are proposed relating to the method of sale or supply of the product (including, in particular, any proposed restrictions affecting the circumstances of the use or promotion of the product); and

(b)if so, what terms are proposed.

Textual Amendments

F622Reg. 127(3)(a)-(c) substituted for words in reg. 127(3) (31.12.2020) by S.I. 2019/775, reg. 113(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 84)

Accompanying materialU.K.

128.—[F624(1) The applicant for the grant of a traditional herbal registration other than a THR(GB) under the unfettered access route must provide the material specified in Schedule 12 in relation to the product.

(1A) The applicant for the grant of a THR(GB) under the unfettered access route must provide—

(a)the application form submitted in connection with the granting of the THR(NI) which authorises the sale or supply of the product in Northern Ireland;

(b)a copy of all material submitted in support of the application for the THR(NI) which authorises the sale or supply of the product in Northern Ireland; and

(c)a copy of the THR(NI) which authorises the sale or supply of the medicinal product in Northern Ireland,

together with any material specified in Schedule 12 which is not included in the material specified in sub-paragraphs (a) to (c) in relation to the product.]

(2) The applicant must also, if requested by the licensing authority to do so, provide the licensing authority with material or information that the licensing authority reasonably considers necessary for considering the application.

(3) If the application relates to a product that is contained in the list referred to in Article 16f(1) of the 2001 Directive [F625where the application is for a THR(NI) or THR(UK), or the list established under regulation 126A where the application is for a THR(GB)]—

(a)the applicant does not need to provide the material referred to in paragraphs 16 to 20 of Part 1 of Schedule 12; and

(b)paragraph (2) of this regulation does not apply.

(4) Material that is submitted under this regulation must be submitted in accordance with Annex I to the 2001 Directive, so far as applicable to traditional herbal medicinal products.

Textual Amendments

F624Reg. 128(1)(1A) substituted for reg. 128(1) (31.12.2020) by S.I. 2019/775, reg. 114(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 85)

Obligation to update information supplied in connection with applicationU.K.

129.—(1) The applicant for a traditional herbal registration must update information supplied in connection with the application to include any further information that is relevant to the evaluation of the safety, quality or efficacy of the product concerned.

(2) Updated information within paragraph (1) must be provided as soon as is reasonably practicable after the applicant becomes aware of it.

Consideration of applicationU.K.

Consideration of applicationU.K.

130.—(1) The licensing authority must take all reasonable steps to ensure that it makes a decision to grant or refuse a traditional herbal registration before the end of the period of 210 days beginning immediately after the day on which an application for the registration is submitted in accordance with regulation 128.

(2) If the licensing authority requests the applicant to provide any further information or material, the period referred to in paragraph (1) is suspended for the period—

(a)beginning with the date on which the request is made; and

(b)ending with the date on which the information or material is provided.

(3) If the licensing authority requests the applicant to give an oral or written explanation of the application, the period referred to in paragraph (1) is suspended for the period—

(a)beginning with the date on which the request is made; and

(b)ending with the date on which the explanation is provided.

(4) The licensing authority may grant the application only if, having considered the application and the accompanying material, the authority thinks that—

(a)the product complies with conditions A to E of regulation 125 (conditions for a product to be a traditional herbal medicinal product);

(b)the product to which the application relates is not harmful under normal conditions of use;

(c)the application and the accompanying material complies with the requirements of this Part;

(d)the product's qualitative and quantitative composition is as described in the application and the accompanying material; and

(e)the product's pharmaceutical quality has been satisfactorily demonstrated.

(5) The licensing authority need not take into account any updated information supplied in connection with the application under regulation 129 (obligation to update information supplied in connection with application), unless it thinks that the information is unfavourable in respect of the safety, quality or efficacy of the product concerned

(6) The licensing authority may refuse the application on the ground that it is more appropriate to consider whether to authorise the placing of the product on the market in response to an application for a [F626UK] marketing authorisation or certificate of registration for the product.

(7) Paragraph (4)(a)

[F627(a)where the application is for a THR(NI) or THR(UK), is subject to Article 16c(4) of the 2001 Directive (procedure where product has been used in the European Union for less than 15 years);

(b)where the application is for a THR(GB), is subject to regulation 130A.]

(8) If the application relates to a herbal medicinal product that is contained in the list referred to Article 16f(1) of the 2001 Directive [F628where the application is for a THR(NI) or THR(UK), or the list established under regulation 126A where the application is for a THR(GB)]—

(a)paragraph (4)(a) applies as if it referred to conditions A to D of regulation 125; and

(b)paragraph (4)(b) does not apply.

(9) Where [F629, in relation to an application for a THR(NI) or THR(UK),] Article 16d(1) of the 2001 Directive (products to which the mutual recognition procedure and decentralised procedure apply) does not apply to the product, the licensing authority must, in considering the application, take into account any registrations granted by other member States in accordance with Chapter 2a of Title III of the 2001 Directive.

(10) The licensing authority must take into account—

(a)any herbal monograph of the kind referred to [F630—

(i)in Article 16h(3) of the 2001 Directive, where the application is for a THR(NI) or THR(UK);

(ii)in regulation 143A, where the application is for a THR(GB),

that the authority thinks relevant to the application; or]

(b)if no relevant monograph within sub-paragraph (a) has been established, such other monographs, publications or data as the authority thinks relevant.

(11) Schedule 11 makes provision about advice and representations in relation to an application for the grant of a traditional herbal registration.

(12) This regulation does not apply where [F631, in relation to an application for a THR(NI) or THR(UK),] Article 16d(1) applies to the product and the application—

(a)has been submitted to the licensing authority in accordance with Article 28 of the 2001 Directive; or

(b)has been referred to the Committee for Herbal Medicinal Products for the application of the procedure laid down in Articles 32 to 34 of the 2001 Directive.

(13) An application to which paragraph (12) applies is to be determined by the licensing authority in accordance with Chapter 4 of Title III of the 2001 Directive.

[F632(14) In the case of an application under the unfettered access route, the licensing authority may grant a THR(GB) (notwithstanding paragraph (4)) where the licensing authority—

(a)has considered the application under the unfettered access route and the accompanying material,

(b)is satisfied that the applicant has complied with the application requirements, and

(c)is satisfied that the conditions in regulation 127(1A) will continue to be met.

(15) The licencing authority may refuse to grant an application under the unfettered access route where it is of the opinion that it would represent a risk to public health to do so.]

Textual Amendments

F630Reg. 130(10)(a)(i)(ii) substituted for words in reg. 130(10)(a) (31.12.2020) by S.I. 2019/775, reg. 116(6) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 87(d)); 2020 c. 1, Sch. 5 para. 1(1)

[F633Procedure where less than 15 years use of traditional herbal medicinal productU.K.

130A.—(1) Where an application for a THR(GB) (other than an application under the unfettered access route) has been made and the licensing authority considers that—

(a)the traditional herbal medicinal product does not satisfy regulation 125(5)(b) (Condition D); but

(b)otherwise satisfies the conditions in regulation 125,

the licensing authority may refer the matter to the appropriate committee for relevant advice, and the procedure in Part 3 of Schedule 11 applies (referral to the appropriate committee for traditional herbal registrations).

(2) In this regulation—

“appropriate committee” has the same meaning as in paragraph 2(4) of Schedule 11;

“relevant advice” means advice as to whether—

(a)

the conditions in regulation 125, other than condition D, are met in relation to the application; and

(b)

the licensing authority should exercise its powers under regulation 143A to establish a herbal monograph.]

Textual Amendments

Classification of traditional herbal registrationU.K.

131.—(1) A traditional herbal registration must include a term that the product to which the registration relates is to be available—

(a)only from a pharmacy; or

(b)on general sale.

(2) A traditional herbal registration may include a term that the product to which the registration relates is to be available on general sale only if the licensing authority considers that the product can with reasonable safety be sold or supplied otherwise than by, or under the supervision of, a pharmacist [F634or by a person who acts in accordance with regulation 220A or 220B (or an exemption in Chapter 3 of Part 12)].

Textual Amendments

Validity of traditional herbal registrationU.K.

Validity of traditional herbal registrationU.K.

132.—(1) Subject to the following paragraphs, a traditional herbal registration remains in force—

(a)for an initial period of five years beginning with the date on which it is granted; and

(b)if the registration is renewed under regulation 133 for an unlimited period after its renewal.

(2) The licensing authority may on the first application for renewal of a registration determine on grounds relating to pharmacovigilance, including exposure of an insufficient number of patients to the medicinal product concerned, that it should be necessary for the holder to make one further application for renewal.

(3) In that event, the registration remains in force—

(a)for a further period of five years beginning with the date on which it is first renewed; and

(b)if the registration is further renewed under regulation 133 for an unlimited period after its further renewal.

(4) If an application for the renewal or further renewal of a registration is made in accordance with regulation 133 the certificate remains in force until the licensing authority notifies the applicant of its decision on the application.

(5) This regulation is subject to—

(a)regulation 134 (failure to place on the market); and

(b)regulation 135 (revocation etc of traditional herbal registration).

Application for renewal of registrationU.K.

133.—(1) An application for the renewal of a traditional herbal registration must be made to the licensing authority.

(2) The applicant [F635, where it is applying for renewal of—

(a)a THR(NI)—

(i)in accordance with Chapter 4 of Title III of the 2001 Directive, must be established in the European Union;

(ii)on any other basis, must be established in the United Kingdom;

(b)a THR(GB)—

(i)under the unfettered access route, must be established in Northern Ireland;

(ii)other than under the unfettered access route, must be established in the United Kingdom;

(c)a THR(UK), must be established in the United Kingdom.]

(3) The application must be—

(a)made in writing;

(b)signed by or on behalf of the applicant; and

(c)unless the licensing authority directs otherwise, accompanied by any fee payable in connection with the application.

(4) An application is treated as signed for the purposes of paragraph (3)(b) if it is signed with an electronic signature.

(5) The application must be made so that it is received by the licensing authority before the beginning of the period of nine months ending with the expiry of the period mentioned in paragraph (1)(a) or (3)(a) of regulation 132 (initial and further period of validity), as the case may be.

(6) The holder must provide a consolidated version of the file in respect of quality, safety and efficacy including—

(a)the evaluation of data contained in suspected adverse reaction reports and periodic safety update reports submitted in accordance with Part 11; and

(b)all variations introduced since the traditional herbal registration was granted.

(7) The licensing authority may renew a traditional herbal registration only if, having considered the application and the material accompanying it, the authority thinks that the positive therapeutic effects of the product to which the registration relates outweigh the risks of the product to the health of patients or of the public.

(8) Schedule 11 makes provision about advice and representations in relation to an application for the renewal of a traditional herbal registration.

Textual Amendments

Failure to place on the market etcU.K.

134.—(1) A traditional herbal registration ceases to be in force if the product to which it relates is not placed on the market in the United Kingdom [F636(or, in the case of a THR(GB) granted after an application under the unfettered access route, in Great Britain)] during the period of three years beginning immediately after the day on which it was granted.

(2) A traditional herbal registration for a product which has been placed on the market ceases to be in force if the product to which it relates is not sold or supplied in the United Kingdom [F637(or, in the case of a THR(GB) granted after an application under the unfettered access route, in Great Britain)] for a period of three years.

(3) This regulation does not apply if the licensing authority grants an exemption from its operation.

(4) An exemption may be granted—

(a)in response to an application in writing by the holder of the traditional herbal registration; or

(b)by the licensing authority of its own motion.

(5) An exemption may only be granted only—

(a)in exceptional circumstances; and

(b)on public health grounds.

(6) An exemption—

(a)has effect for the period determined by the licensing authority, which may not exceed three years beginning with the day on which it is granted; and

(b)may be renewed or further renewed.

Textual Amendments

Revocation, variation and suspension of traditional herbal registrationU.K.

Revocation, variation and suspension of traditional herbal registrationU.K.

135.—(1) The licensing authority may revoke, vary or suspend a traditional herbal registration if any of the following conditions are met.

(2) Condition A is that the licensing authority thinks that—

(a)the product to which the registration relates is harmful;

(b)the pharmacological effects or efficacy of the product are no longer plausible; or

(c)the product's qualitative or quantitative composition is not as described in the application for the registration or the material accompanying it.

(3) Condition B is that the licensing authority thinks that the application or the material supplied with it is incorrect.

(4) Condition C is that the licensing authority thinks that there has been a breach of—

(a)a term of the registration; or

(b)a requirement imposed by Chapter 1 of Part 13 (packaging and leaflets).

(5) Condition D is that the licensing authority thinks that the holder of the registration has not complied with regulation 145(1) to (3) (requirement to provide information that may entail amendment of authorisation).

[F638(6) Condition E is that the holder of the registration has ceased to be established in—

(a)the United Kingdom; or

(b)in relation to a THR(NI), either the United Kingdom or the European Union,

in accordance with the requirements of these Regulations.]

(7) Condition F is that—

(a)the product to which the registration relates is manufactured in the United Kingdom; and

(b)the licensing authority thinks that the holder of the manufacturer's licence for the product has failed to comply in relation to the product with regulations 37 (manufacturing and assembly), 38 (imports from states other than EEA States [F639/ countries other than approved countries for import]), 39 (further requirements for manufacturer's licence), 40 (obligation to provide information relating to control methods) or 41 (requirements as to qualified persons).

(8) Condition G is that—

(a)the product to which the registration relates is manufactured in an EEA State F640...; and

(b)the licensing authority thinks that the holder of the manufacturer's licence for the product has failed to comply in relation to the product with provision giving effect to Article 41 of the 2001 Directive (requirements relating to manufacturing authorisations) in that member State.

(9) Condition H is that the licensing authority thinks that urgent action to protect public health is necessary, in which case it—

(a)may suspend the registration; and

(b)[F641in the case of a THR(NI) or THR(UK),] must notify the suspension to the EMA, the European Commission, and all other member States by the end of the next working day following the day on which the suspension comes into force.

(10) Condition I is that—

(a)the holder applies to vary the registration; and

(b)the licensing authority thinks that the application should be granted.

[F642(10A) Condition J is that the manufacture of the product to which registration relates is not carried out in compliance with the particulars provided under paragraphs 5 and 9 of Schedule 12.]

[F643(10B) Condition K is that the licensing authority thinks that the revocation, variation or suspension is necessary or expedient in light of the Protocol on Ireland/Northern Ireland in the withdrawal agreement.]

F644(11) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Revocation by licensing authority: further provisionsU.K.

136.—(1) The licensing authority must revoke a traditional herbal registration if—

(a)the application for the registration was submitted in accordance with regulation 128(3) on the basis that the herbal medicinal product to which it relates was contained in

[F645(i)the list referred to in Article 16f(1) of the 2001 Directive, in the case of a THR(NI) or THR(UK);

(ii)the list established under regulation 126A where the application is for a THR(GB); and]

(b)the product ceases to be contained in that list.

(2) Paragraph (1) does not apply if within the period of three months beginning immediately after the day on which product ceases to be contained on the list the holder—

(a)submits to the licensing authority the material specified in Schedule 12 (including that referred to in paragraphs 16 to 20 of Part 1 of that Schedule) in relation to the product; and

(b)provides the licensing authority with any material or information that the licensing authority reasonably considers necessary for considering the application and requests the holder to provide.

F646(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F645Reg. 136(1)(a)(i)(ii) substituted for words in reg. 136(1)(a) (31.12.2020) by S.I. 2019/775, reg. 120(2) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 92); 2020 c. 1, Sch. 5 para. 1(1)

Procedures for revocation, variation or suspensionU.K.

137.  Schedule 11 makes provision about advice and representations in relation to a proposal to revoke, vary or suspend a traditional herbal registration, other than a proposal to vary a registration on the application of its holder.

Suspension of use etc of traditional herbal medicinal productU.K.

138.—(1) The licensing authority may suspend the use, sale, supply or offer for sale or supply within the United Kingdom of a product to which a traditional herbal registration relates if any of the following conditions are met.

(2) Condition A is that the licensing authority thinks that—

(a)the product is harmful;

(b)the pharmacological effects or efficacy of the product are no longer plausible; or

(c)the product's qualitative or quantitative composition is not as described in the application for the registration or the material accompanying it.

(3) Condition B is that the licensing authority thinks that the holder has not complied with regulation 145(7) (requirements to provide proof of controls on manufacturing process).

(4) Condition C is that the licensing authority thinks that there has been a breach of—

(a)a term of the registration; or

(b)a requirement imposed by Chapter 1 of Part 13 (packaging and leaflets).

(5) Condition D is that the licensing authority thinks that paragraph (4) or (5) of regulation 23 (power to revoke, suspend or vary manufacturers' licences) applies in relation to the manufacturer's licence for the product.

(6) A suspension under this regulation may relate to batches of the product.

(7) The licensing authority must give notice in writing of a suspension under this regulation to the holder of the registration.

(8) The licensing authority must provide in the notice that the suspension—

(a)is to take effect immediately or from a date specified in the notice; and

(b)is to apply for the period specified in the notice.

(9) Where a medicinal product is the subject of a suspension under this regulation, the licensing authority may—

(a)in exceptional circumstances; and

(b)for such a transitional period as the licensing authority may determine,

allow the supply of the medicinal product to patients who are already being treated with the medicinal product.

F647(10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Registrations granted under Chapter 4 of Title III of the 2001 DirectiveU.K.

F648139.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Withdrawal of traditional herbal medicinal product from the marketU.K.

140.—(1) This regulation applies if—

[F649(a)under—

(i)regulation 135 or 136, in the case of a THR(GB);

(ii)regulation 135 or 136 or Article 34(3) of the 2001 Directive, in the case of a THR(NI) or THR(UK),

the licensing authority revokes or suspends the registration; or]

(b)under regulation 138 the licensing authority suspends the use, sale, supply or offer for sale or supply within the United Kingdom of a product to which a traditional herbal registration relates.

(2) The licensing authority may give written notice to the person who is, or immediately before its revocation was, the holder of the registration requiring the holder to comply with both of the following requirements.

(3) Requirement A is to take all reasonably practicable steps to inform wholesalers, retailers, medical practitioners, patients and others who may be in possession of the product to which the registration relates of—

(a)the revocation or suspension;

(b)the reasons for the revocation or suspension; and

(c)any action to be taken to restrict or prevent further use, sale, supply or offer for sale or supply of the product.

(4) Requirement B is to take all reasonably practicable steps to withdraw from the market in the United Kingdom and recover possession of—

(a)the product; or

(b)the batches of the product specified in the notice,

within the time and for the period specified in the notice.

Textual Amendments

Sale etc of suspended traditional herbal medicinal productU.K.

141.—(1) This regulation applies if the use, sale, supply or offer for sale or supply of a traditional herbal medicinal product is suspended in accordance with regulation 138 F650....

(2) A person must not—

(a)sell, supply or offer to sell or supply the product; or

(b)procure the sale, supply or offer for sale or supply of the product,

knowing, or having reasonable cause to believe, that such use, sale, supply or offer for sale or supply is suspended.

Textual Amendments

Obligations of holder of traditional herbal registrationU.K.

Obligation to notify placing on the market etcU.K.

142.—(1) The holder of a traditional herbal registration must notify the licensing authority of the date on which the product to which the registration relates is placed on the market in the United Kingdom taking account of the various presentations authorised.

(2) A notification under paragraph (1) must be given before the end of the period of two months beginning with the date on which the product is placed on the market.

(3) The holder of a traditional herbal registration must notify the licensing authority if the product to which the registration relates is to be withdrawn from the market in the United Kingdom (whether temporarily or permanently).

(4) A notification under paragraph (3) must be given before the beginning of the period of two months ending with the date on which the product is to be withdrawn from the market unless it is not reasonably practicable to do so.

(5) In that event, the notification must be given as far as is reasonably practicable in advance of the date on which the product is withdrawn from the market.

[F651(5A) The holder of a traditional herbal registration must notify the licensing authority forthwith if the holder takes action to—

(a)request the cancellation of the registration;

(b)not apply for the renewal of the registration; or

(c)withdraw the product to which the registration relates from the market in a third country (whether temporarily or permanently) and the action is based on any of the grounds set out in Article 116 or 117(1) of the 2001 Directive.

(5B) A notification under paragraph (3) or (5A) must include the reasons for the action, in particular declaring if the action is based on any of the grounds set out in Article 116 or 117(1) of the 2001 Directive.

(5C) The holder of a [F652THR(NI) or THR(UK)] must notify the EMA forthwith where the action which is the subject of a notification by the holder under paragraph (3) or (5A) is based on any of the grounds set out in Article 116 or 117(1) of the 2001 Directive.]

(6) The licensing authority may require the holder of a traditional herbal registration to provide information relating to the volume of sales in the United Kingdom of the product to which the registration relates.

(7) The holder of a traditional herbal registration must provide the licensing authority with information that it requires under paragraph (6)—

(a)where the period within which the information must be provided is specified in a written notice given to the holder by the licensing authority, before the end of that period; or

(b)otherwise, as soon as is reasonably practicable after receipt of the request.

Textual Amendments

Obligation to take account of scientific and technical progressU.K.

143.—(1) The holder of a traditional herbal registration must keep under review the methods of manufacture and control of the product to which the registration relates, taking account of scientific and technical progress.

(2) As soon as is reasonably practicable after becoming aware of the need to do so, the holder must apply to vary the traditional herbal registration to make any changes to those methods that are required to ensure they are generally accepted scientific methods.

[F653Establishment of herbal monographsU.K.

143A.—(1) The licensing authority may establish herbal monographs for herbal medicinal products and traditional herbal medicinal products to be placed on the market in Great Britain.

(2) Subject to paragraph (3), the licensing authority must—

(a)consult the appropriate committee, within the meaning of paragraph 2(4) of Schedule 11, on a proposal to establish herbal monographs under paragraph (1); and

(b)take the advice of the appropriate committee into account in determining whether to proceed with that proposal.

(3) Where an application for a traditional herbal registration has been referred to the appropriate committee by the licensing authority under regulation 130A, the licensing authority must consider whether to exercise its powers under paragraph (1), taking into account any relevant advice of the appropriate committee given under Part 3 of Schedule 11 in relation to that application.

(4) The licensing authority must publish a list of any herbal monographs established under this regulation.

(5) Until the licensing authority exercises the power under paragraph (1), the Community herbal monographs published from time to time under Article 16h(3) of the 2001 Directive continue to apply, and holders of a traditional herbal registration and the licensing authority must continue to take them into account in exercising any function or in relation to any obligation to which they are relevant under this Part.]

Textual Amendments

Obligation following new herbal monographU.K.

[F654144.—(1) Paragraph (2) applies where a new herbal monograph of the kind referred to—

(a)in the case of a THR (NI) or THR (UK), in Article 16h(3) of the 2001 Directive, or

(b)in the case of a THR (GB), in regulation 143A,

is established.

(2) Where this paragraph applies, the holder of the THR(GB), THR(NI) or THR(UK) to which the monograph relates must as soon as is reasonably practicable—

(a)consider whether to modify the registration dossier; and

(b)notify any modification to the licensing authority.]

Textual Amendments

Obligation to provide information relating to safety etcU.K.

145.—(1) The holder of a traditional herbal registration must provide the licensing authority with any new information that might entail the variation of the registration.

(2) The holder must, in particular, provide the licensing authority with the following information—

(a)information about any prohibition or restriction imposed in relation to the product to which the registration relates by the competent authority of any country in which the product is on the market;

(b)positive and negative results of clinical trials or other studies in all indications and populations, whether or not included in the traditional herbal registration;

(c)data on the use of the product where such use is outside the terms of the traditional herbal registration; and

(d)any other information that the holder considers might influence the evaluation of the benefits and risks of the product.

(3) Information within paragraph (1) or (2) must be provided as soon as is reasonably practicable after the holder becomes aware of it.

(4) The licensing authority may require the holder of a traditional herbal registration to provide the authority with information that—

(a)is specified by the licensing authority; and

(b)demonstrates that the positive therapeutic effects of the product to which the registration relates outweigh the risks of the product to the health of patients or of the public.

(5) The information that may be required under paragraph (4) includes information arising from use of the product—

(a)in a country [F655other than the United Kingdom]; or

(b)outside the terms of the traditional herbal registration,

including use in clinical trials.

(6) If the information supplied under paragraph (1), (2) or (4) entails the variation of the traditional herbal registration, the holder must make an application to the licensing authority to that effect as soon as is reasonably practicable after becoming aware of the information.

(7) The licensing authority may require the holder of a traditional herbal registration to provide the authority with proof of the control methods employed by the manufacturer of the product to which the registration relates.

(8) The holder of a traditional herbal registration must provide the licensing authority with information that it requires under paragraph (4) or (7)—

(a)where the period within which the information must be provided is specified in a written notice given to the holder by the licensing authority, before the end of that period; or

(b)otherwise, as soon as is reasonably practicable after receipt of the request.

Textual Amendments

Obligation in relation to product informationU.K.

146.—(1) The holder of the traditional herbal registration for a medicinal product must ensure that the product information relating to the product is kept up to date with current scientific knowledge.

[F656(2) In this regulation “current scientific knowledge” includes the conclusions of the assessment and recommendations made public by means of—

(a)in the case of a medicinal product for sale or supply in Northern Ireland—

(i)the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004, and

(ii)the UK web-portal established in accordance with regulation 203(1);

(b)in the case of a medicinal product for sale or supply in Great Britain only, the UK web-portal established in accordance with regulation 203(1).]

Textual Amendments

Record-keeping obligationsU.K.

147.  The holder of a traditional herbal registration must keep any documents or information that will facilitate the withdrawal or recall from sale or supply of any product to which the registration relates.

Obligation to ensure appropriate and continued suppliesU.K.

148.  The holder of a traditional herbal registration must take all reasonable steps to ensure appropriate and continued supplies of the product to which the registration relates to pharmacies and persons authorised to supply the product so that the needs of patients in the United Kingdom are met.

[F657Urgent safety restrictionsU.K.

148A.—(1) Where, in the event of a risk to public health, the holder of a traditional herbal registration takes urgent safety restrictions on its own initiative, it must inform the licensing authority immediately.

(2) If the licensing authority has not raised objections within 24 hours following receipt of that information, the urgent safety restrictions are deemed to be accepted by the licensing authority.

(3) In the event of a risk to public health, the licensing authority may impose urgent safety restrictions.

(4) Where an urgent safety restriction is taken by the holder of a traditional herbal registration, or imposed by the licensing authority, the holder must submit an application for variation of that registration in relation to that restriction within 15 days beginning with the date of the initiation of that restriction.]

Textual Amendments

Offences relating to traditional herbal registrationsU.K.

Urgent safety restrictionsU.K.

[F658149.—(1) The holder of a THR(NI) or a THR(UK) is guilty of an offence if the holder—

(a)fails to inform the licensing authority or the European Commission in accordance with Article 22(1) of Regulation (EC) No 1234/2008 that the holder has taken urgent safety restrictions on the holder's own initiative;

(b)fails to implement an urgent safety restriction imposed on the holder by the licensing authority or the European Commission under Article 22(2) of that Regulation; or

(c)fails to submit an application for variation of the traditional herbal registration to the licensing authority or the European Commission in accordance with Article 22(3) of that Regulation before the end of a period of fifteen days beginning on the day after—

(i)the taking under Article 22(1) or, as the case may be,

(ii)the imposition under Article 22(2),

of that Regulation of an urgent safety restriction;

(2) The holder of a THR(GB) is guilty of an offence if the holder—

(a)fails to inform the licensing authority in accordance with regulation 148A(1) that the holder has taken urgent safety restrictions on the holder's own initiative;

(b)fails to implement an urgent safety restriction imposed on the holder by the licensing authority in accordance with regulation 148A(2); or

(c)fails to submit an application for variation of the traditional herbal registration to the licensing authority in accordance with regulation 148A(4) before the end of the period of 15 days beginning with the day after—

(i)the taking under regulation 148A(1), or

(ii)the imposition under regulation 148A(2),

of an urgent safety restriction.]

Textual Amendments

Offences in connection with applicationsU.K.

150.  A person is guilty of an offence if in the course of an application for the grant, renewal or variation of a traditional herbal registration for a traditional herbal medicinal product the person—

(a)fails to provide the licensing authority with any information that is relevant to the evaluation of the safety, quality or efficacy of the product; or

(b)provides to the licensing authority any information that is relevant to the evaluation of the safety, quality or efficacy of the product that is false or misleading in a material particular.

Provision of false or misleading informationU.K.

151.—(1) The holder of a traditional herbal registration is guilty of an offence if the holder provides to the licensing authority any information that is relevant to the evaluation of the safety, quality or efficacy of a traditional herbal medicinal product but that is false or misleading in a material particular.

(2) Paragraph (1) is without prejudice to regulation 150.

General offence of breach of provision of this PartU.K.

152.—(1) A person is guilty of an offence if that person commits a breach of a provision in this Part.

(2) A breach of a provision in this Part includes any—

(a)failure by the holder of a traditional herbal registration to comply with any requirement or obligation in this Part;

(b)contravention by any person of any prohibition in this Part; or

(c)failure to comply with any requirement imposed on a person by the licensing authority pursuant to this Part.

(3) Paragraph (1) is without prejudice to any offence established by any other provision in this Part.

PenaltiesU.K.

153.  A person guilty of an offence under this Part is liable—

(a)on summary conviction, to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment, to a fine, to imprisonment for a term not exceeding two years or to both.

Persons liableU.K.

154.  If an offence under regulation 150 (offences in connection with applications) is committed by a person acting as employee or agent, the employer or principal of that person is guilty of the same offence and is liable to be proceeded against and punished accordingly.

DefencesU.K.

155.—(1) Paragraph (2) applies if the holder of a traditional herbal registration is charged with an offence under this Part in respect of anything that—

(a)has been manufactured or assembled to the holder's order by another person; and

(b)has been so manufactured or assembled as not to comply with the terms of the authorisation.

(2) It is a defence for the holder to prove that—

(a)the holder communicated the terms of the registration to the other person; and

(b)the holder did not know and could not by the exercise of reasonable care have known that those terms had not been complied with.

(3) It is a defence for a person charged with an offence consisting of a breach of regulation 142(3) or 148 or an offence under regulation 150 or 151 to prove that the person took all reasonable precautions and exercised all due diligence to avoid commission of that offence.

(4) Where evidence is adduced that is sufficient to raise an issue with respect to the defence in paragraph (3), the court or jury must presume that the defence is satisfied unless the prosecution proves beyond reasonable doubt that it is not.

PART 8U.K.Article 126a authorisations

Article 126a authorisationsU.K.

156.—(1) The licensing authority may grant an Article 126a authorisation for [F659sale or supply of] a medicinal product [F660in Northern Ireland only,] if the following conditions are met.

(2) Condition A is that no United Kingdom marketing authorisation, certificate of registration or traditional herbal registration is in force [F661in Northern Ireland] for the product.

(3) Condition B is that no application is pending in the United Kingdom for a marketing authorisation, certificate of registration or traditional herbal registration [F662to be in force in Northern Ireland] for the product.

(4) Condition C is that the licensing authority considers that the placing of the product on the market in [F663Northern Ireland] is justified for public health reasons.

(5) Condition D is that the product is imported from [F664an EU member State] that has, in accordance with the 2001 Directive, authorised the placing on the market of the product in that member State.

(6) Condition E is that the person to whom the authorisation is granted is established in the European Union.

(7) Before granting an Article 126a authorisation, the licensing authority must notify the authorisation holder in the member State mentioned in paragraph (5) of the proposal to grant the Article 126a authorisation.

(8) Before granting an Article 126a authorisation, the licensing authority may request the competent authority in the member State mentioned in paragraph (5) to provide in accordance with Article 126a(3)(b) of the 2001 Directive a copy of—

(a)the assessment report for that product as mentioned in Article 21(4) of the 2001 Directive; and

(b)the authorisation in force for that product.

(9) An Article 126a authorisation remains in force for the period specified in it unless revoked before the end of that period.

(10) That period may be specified by reference to the occurrence or non-occurrence of a particular event or events.

Textual Amendments

Requests from [F665EU member States] U.K.

157.—(1) Paragraph (2) applies where the licensing authority [F666, in relation to a UKMA(NI),] is requested by the competent authority of [F667a member State] to provide in accordance with Article 126a(3)(b) of the 2001 Directive a copy of—

(a)the assessment report for a medicinal product as mentioned in regulation 64(5) (duties of licensing authority in connection with determination); and

(b)the marketing authorisation in force for that product.

(2) The licensing authority must supply those documents to the competent authority before the end of the period of thirty days beginning on the day after the request is received.

Textual Amendments

Application of these RegulationsU.K.

158.  The following provisions of Part 5 (marketing authorisations) apply to an Article 126a authorisation as they apply to a marketing authorisation—

(a)regulation 62 (classification of marketing authorisation);

(b)regulation 63 (frequency of periodic safety update reports);

(c)regulation 68 (revocation etc of marketing authorisation) and Schedule 11 (advice and representations in connection with revocations etc) so far as relating to that regulation;

(d)regulation 69 (suspension of use etc of medicinal product);

(e)regulation 71 (withdrawal of medicinal products from the market);

(f)regulation 72 (sale etc of suspended medicinal product);

(g)regulation 80 (urgent safety restrictions); and

(h)regulations 98 (general offence of breach of provision of this Part), 99 (penalties) and 101(1) and (2) (defences), so far as relating to the regulations mentioned in sub-paragraphs (a) and (e) to (f).

PART 9U.K.Borderline products

Provisional determinationU.K.

159.—(1) This regulation applies if the licensing authority thinks that a product without a [F668UK] marketing authorisation, traditional herbal registration, certificate of registration or [F669, only in relation to a product for sale or supply in Northern Ireland, an Article 126a authorisation F670...,] is a medicinal product.

(2) The licensing authority may give a notice in writing (a “provisional determination notice”) to any person (the “recipient”)—

(a)who has sold or supplied the product, or has offered to sell or supply it; or

(b)whom the licensing authority thinks may sell or supply the product.

(3) The provisional determination notice must—

(a)advise the recipient that the licensing authority has made a provisional determination that the product is a medicinal product;

(b)give reasons for the provisional determination;

(c)advise the recipient of the recipient's rights to challenge the provisional determination in accordance with regulation 160 and

(d)specify a period of at least six weeks beginning immediately after the date on which the provisional determination notice is given to the recipient (in this Part “the determination date”) within which any written representations in accordance with regulation 160(2)(a) must be made to the licensing authority.

Textual Amendments

Challenge to provisional determinationU.K.

160.—(1) A recipient of a provisional determination notice may, within the period of four weeks beginning immediately after the determination date, give notice in writing to the licensing authority requesting the authority to submit the provisional determination to review.

(2) If the recipient gives such notice the recipient must—

(a)within the period specified in the provisional determination notice, make written representations to the licensing authority explaining why the recipient thinks the product is not a medicinal product; or

(b)within the period of four weeks beginning immediately after the determination date, inform the licensing authority in writing that the recipient wants to make oral representations explaining why the recipient thinks the product is not a medicinal product.

(3) If—

(a)the recipient has informed the licensing authority that the recipient wants to make written representations in accordance with paragraph (2)(a); and

(b)the licensing authority thinks that, because of exceptional circumstances or the nature or complexity of the issues involved, additional time is needed for the preparation of written representations,

the licensing authority may alter the period for making written representations.

(4) The licensing authority must inform the recipient in writing of an alteration under paragraph (3) and of the reasons for it.

Written representations procedureU.K.

161.—(1) If a recipient makes written representations in accordance with regulation 160(2)(a) the licensing authority must appoint a panel of at least two persons (“the reviewers”) to advise on the provisional determination.

(2) The licensing authority must provide the reviewers with—

(a)the recipient's written representations; and

(b)any written representations of the licensing authority.

(3) The reviewers must advise the licensing authority on the authority's provisional determination taking account of—

(a)the written representations; and

(b)any other evidence submitted to them.

(4) The licensing authority must take into account the reviewers' advice and make a final determination as to whether the product is a medicinal product.

(5) The licensing authority must—

(a)inform the recipient in writing of its final determination and of the reasons for it; and

(b)if the licensing authority disagrees with the reviewers' advice, inform the recipient in writing of the reasons for that disagreement.

Oral representations procedureU.K.

162.—(1) If a recipient informs the licensing authority in accordance with regulation 160(2)(b) that the recipient wants to make oral representations, the licensing authority must—

(a)appoint a panel of at least two persons (“the reviewers”) to conduct the review; and

(b)after consultation with the recipient set a date for the hearing.

(2) The licensing authority may alter the date of the hearing at the request of the recipient or of its own motion if it thinks that because of exceptional circumstances or the nature or complexity of the issues involved additional time is needed for preparation for the hearing.

(3) The licensing authority must inform the recipient in writing of any alteration under paragraph (2) and of the reasons for it.

(4) The recipient and the licensing authority may make oral representations at the hearing.

(5) The reviewers must advise the licensing authority on the authority's provisional determination, taking account of—

(a)the oral representations made and any other evidence submitted by the recipient at the hearing;

(b)any oral representations made or other evidence submitted by the licensing authority at the hearing; and

(c)any other evidence heard by the review panel.

(6) The licensing authority must take into account the reviewers' advice and make a final determination as to whether the product is a medicinal product.

(7) The licensing authority must—

(a)inform the recipient in writing of its final determination and of the reasons for it; and

(b)if the licensing authority disagrees with the reviewers' advice, inform the recipient in writing of the reasons for that disagreement.

Final determination without representationsU.K.

163.—(1) This regulation applies if the recipient—

(a)does not give notification to the licensing authority that the recipient wishes to challenge its provisional determination within the period of four weeks beginning immediately after the determination date;

(b)gives such notification, but fails to make written representations to the licensing authority within the period for making those representations; or

(c)gives such notification, but fails to make oral representations at a hearing before the reviewers appointed for the purposes of advising on the provisional determination.

(2) The licensing authority must—

(a)make a final determination as to whether the product is a medicinal product; and

(b)inform the recipient in writing of its final determination and of the reasons for it.

Effect of final determinationU.K.

164.—(1) If the licensing authority makes a final determination that a product is a medicinal product, it may give a notice to any person—

(a)who has sold or supplied the product, or has offered to sell or supply it; or

(b)whom the licensing authority thinks may sell or supply the product.

(2) The notice must require the person—

(a)to cease to sell, supply or offer to sell or supply the product from the date specified in the notice until a [F671UK] marketing authorisation, traditional herbal registration, certificate of registration or [F672, only in relation to a product for sale or supply in Northern Ireland, an Article 126a authorisation F673...,] is granted in respect of the product; or

(b)not to sell, supply or offer to sell or supply the product unless a [F674UK] marketing authorisation, traditional herbal registration, certificate of registration or [F675, only in relation to a product for sale or supply in Northern Ireland, an Article 126a authorisationF676...,] is granted in respect of the product.

Textual Amendments

F675Words in reg. 164(2)(b) substituted (31.12.2020) by virtue of S.I. 2019/775, reg. 134(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 101)

Determination in other casesU.K.

165.  Nothing in this Part prevents the licensing authority from determining that a product is a medicinal product [F677in relation to these Regulations] without following the procedures in this Part when it thinks it appropriate.

Textual Amendments

F677Words in reg. 165 inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 3 and words in reg. 165 inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 3

Offences relating to borderline productsU.K.

166.—(1) A person is guilty of an offence if that person sells or supplies, or offers to sell or supply a product in breach of a notice under regulation 164(1) imposing a requirement under—

(a)regulation 164(2)(a); or

(b)regulation 164(2)(b).

(2) A person guilty of an offence under this regulation is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment, to a fine, to imprisonment for a term not exceeding two years or to both.

PART 10U.K.Exceptions to requirement for marketing authorisation etc

ExceptionsU.K.

Supply to fulfil special patient needsU.K.

167.—(1) The prohibitions in regulation 46 (requirement for authorisation) do not apply in relation to a medicinal product (a “special medicinal product”) if—

(a)the medicinal product is supplied in response to an unsolicited order;

(b)the medicinal product is manufactured and assembled in accordance with the specification of a person who is a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber;

(c)the medicinal product is for use by a patient for whose treatment that person is directly responsible in order to fulfil the special needs of that patient; and

(d)the following conditions are met.

(2) Condition A is that the medicinal product is supplied—

(a)to a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber; or

(b)for use under the supervision of a pharmacist in a registered pharmacy, a hospital or a health centre.

(3) Condition B is that no advertisement relating to the medicinal product is published by any person.

(4) Condition C is that—

(a)the manufacture and assembly of the medicinal product are carried out under such supervision; and

(b)such precautions are taken,

as are adequate to ensure that the medicinal product meets the specification of the doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber who requires it.

(5) Condition D is that written records of the manufacture or assembly of the medicinal product in accordance with condition C are maintained and are available to the licensing authority or to the enforcement authority on request.

(6) [F678Except in the case of an MM medicinal product or a POC medicinal product,] condition E is that if the medicinal product is manufactured or assembled in the United Kingdom [F679, imported into Northern Ireland from a country other than an EEA State or Great Britain, or imported into Great Britain from a country other than an approved country for import or Northern Ireland]—

(a)it is manufactured, assembled or imported by the holder of a manufacturer's licence that relates specifically to the manufacture, assembly or importation of special medicinal products; or

(b)it is manufactured, assembled or imported as an investigational medicinal product by the holder of a manufacturing authorisation granted by the licensing authority for the purposes of regulation 36 of the Clinical Trials Regulations.

[F680(6A) In the case of an MM medicinal product, condition E is that the product is manufactured or assembled by the holder of a manufacturer’s licence (MM) that relates specifically to the manufacture or assembly of special medicinal products and in accordance with the MM master file relating to the product.

(6B) In the case of a POC medicinal product, condition E is that the product is manufactured or assembled by the holder of a manufacturer’s licence (POC) that relates specifically to the manufacture or assembly of special medicinal products and in accordance with the POC master file relating to the product.]

(7) Condition F is that if the product is [F681imported into Northern Ireland from an EEA State or imported into Great Britain from F682... an approved country for import]—

[F683(a)it is manufactured or assembled in that State or country (as appropriate) by a person who is the holder of an authorisation in relation to its manufacture or assembly in accordance with—

(i)in the case of a product for sale or supply in Northern Ireland, the provisions of the 2001 Directive as implemented in that State, and

(ii)in the case of a product for sale or supply in Great Britain, in accordance with the provisions applicable in that country; or]

[F684(b)it is manufactured or assembled as an investigational medicinal product in that State or country (as appropriate) by the holder of an authorisation in relation to its manufacture or assembly in accordance with—

(i)in the case of a product for sale or supply in Northern Ireland, Article 13 of the Clinical Trials Directive as implemented in that State, and

(ii)in the case of a product for sale or supply in Great Britain, regulations 13 and 43 of the Clinical Trials Regulations,]

[F685and it is imported by the holder of a wholesale dealer’s licence in relation to the product in question.]

(8) Condition G is that if the product is distributed by way of wholesale dealing by a person (“P”), who has not, as the case may be, manufactured, assembled or imported the product in accordance with paragraph (6)(a) or (7)(a), P must be the holder of a wholesale dealer's licence in relation to the product in question.

(9) In this regulation “publish” has the meaning given in regulation 277(1) (interpretation: Part 14 advertising).

Textual Amendments

F685Words in reg. 167(7)(b) inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 5(2)(b) and words in reg. 167(7)(b) inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 5(2)(b)

[F686NIMAR supply to Northern IrelandU.K.

167A.—(1) If the following conditions are met—

(a)the prohibitions in regulation 46 (requirement for authorisation) do not apply in relation to a medicinal product sold or supplied, or offered for sale or supply, in Northern Ireland, and

(b)that product is classified in Northern Ireland as a prescription only medicine.

(2) Condition A is that a UK marketing authorisation of a following type is in force for the product—

(a)a UKMA(UK);

(b)a UKMA(GB).

(3) Condition B is that the product is classified as a prescription only medicine in accordance with regulation 5(3) for the purposes of sale and supply in Great Britain.

(4) Condition C is that the product is a listed NIMAR product.

(5) Condition D is that if the product is to be distributed by wholesale dealing by a person (“P”) in Northern Ireland, P must be a holder of a wholesale dealer’s licence.

(6) Condition E is that if the product is manufactured or assembled in Great Britain, it is supplied to Northern Ireland—

(a)by the holder of a manufacturer’s licence in respect of that product; or

(b)by the holder of a wholesale dealer’s licence.

(7) Condition F is that if the product is manufactured outside of the UK and imported into Great Britain, it is supplied to Northern Ireland—

(a)by a holder of a manufacturer’s licence in respect of that product; or

(b)by the holder of a wholesale dealer’s licence.

Textual Amendments

List of NIMAR productsU.K.

167B.—(1) The licensing authority must maintain a list for the purposes of regulation 167A(4).

(2) In relation to each listed NIMAR product, the list must specify the date the NIMAR product was added to the list.

(3) The licensing authority must publish the list and keep it up to date.

(4) A product may only be included on the list if the following conditions are satisfied—

(a)Condition A is that the Secretary of State has in relation to Northern Ireland been provided with at least one of the following—

(i)information requested under regulation 28 (provision of information about availability of health service medicines) of the 2018 Regulations;

(ii)information under regulation 29 (requirement to provide information about discontinuation or anticipated supply shortage of certain health service medicines) of the 2018 Regulations;

(b)Condition B is that the holder of a UK marketing authorisation, has notified the Secretary of State that—

(i)in relation to a medicinal product to which a UKMA(UK) relates, the qualified person who is at the disposal of the holder of a manufacturer’s licence is unable to secure the matters mentioned in paragraph 12A of Schedule 7 for the purpose of supplying the product into Northern Ireland from Great Britain; or

(ii)in relation to a medicinal product to which a UKMA(GB) relates, the inability of a qualified person who is at the disposal of the holder of a manufacturer’s licence to secure the matters mentioned in paragraph 12A of Schedule 7 prevents the holder of the UKMA(GB) from converting it into a UKMA(UK);

(c)Condition C is that the licensing authority considers that clinical needs in Northern Ireland for the product may be unmet.

(5) The licensing authority must remove a product from the list if the licensing authority considers that medicinal products, not including listed NIMAR products, available in Northern Ireland are capable of meeting clinical need.]

Textual Amendments

[F687Early Access to Medicines Scheme: establishment and licensing authority functionsU.K.

167C.—(1) The licensing authority must establish and operate a scheme, to be known as the Early Access to Medicines Scheme—

(a)the purpose of which is to give patients with life threatening or seriously debilitating conditions access to medicinal products that may be used for preventing, diagnosing or treating those conditions but which are either not authorised or not authorised for that use; and

(b)which is to include arrangements to support the collection of data about EAMS medicinal products.

(2) The licensing authority has the following functions with regard to the Early Access to Medicines Scheme—

(a)issuing, where appropriate, a designation (“Promising Innovative Medicines designation”) in respect of a product under consideration for inclusion in the Scheme to the person who is or may in due course be responsible for placing the product on the market, after concluding based on early clinical and non-clinical data that the medicinal product may be eligible for inclusion in the Scheme because—

(i)there is a life threatening or seriously debilitating condition and a high unmet need,

(ii)the medicinal product is likely to offer a major advantage over methods of preventing, diagnosing or treating the condition already in use in the United Kingdom, and

(iii)the potential adverse effects of the medicinal product are likely to be outweighed by the potential benefits, allowing for a reasonable expectation of a positive risk-benefit balance;

(b)issuing, where appropriate, an opinion (“EAMS scientific opinion”) to a holder of a Promising Innovative Medicines designation to the effect that the holder is able—

(i)to demonstrate that there is a life threatening or seriously debilitating condition and a high unmet need,

(ii)to demonstrate that the medicinal product offers a major advantage over methods of preventing, diagnosing or treating the condition already in use in the United Kingdom,

(iii)to demonstrate that the potential adverse effects of the medicinal product are outweighed by the potential benefits, allowing for a reasonable expectation of a positive risk-benefit balance,

(iv)to supply the product to or within the United Kingdom (or a part thereof) for use as part of the Scheme, and

(v)to manufacture, or secure the manufacturing of, the product to a consistent quality standard and in compliance with good manufacturing practice,

as a consequence of which the product is included in and may be supplied as part of the Scheme;

(c)where it issues an opinion under sub-paragraph (b), attaching where appropriate conditions, which may be varied from time to time, to the access to the Scheme that the opinion gives (which may include conditions that are equivalent to requirements of Part 13);

(d)revoking, pursuant to paragraph (3), opinions issued in accordance with sub-paragraph (b); and

(e)renewing opinions issued in accordance with sub-paragraph (b) that would otherwise cease to have effect in accordance with regulation 167D(1).

(3) The licensing authority may, if it is reasonable to do so, revoke an EAMS scientific opinion at any time (as a consequence of which, subject to regulation 167D(2), the product can no longer be supplied as part of the Scheme) if—

(a)there is a breach of the conditions referred to in paragraph (2)(c);

(b)there is a breach of regulation 167E to 167G; or

(c)sufficient grounds no longer exist for inclusion of the product within the Scheme.

(4) For the purposes of this regulation and regulations 167E and 167G, “authorised” has the meaning given in regulation 3(15), and (including the purposes of regulation 43(6)(aa)) “unauthorised” is to be construed accordingly.

Textual Amendments

EAMS scientific opinions ceasing to have effectU.K.

167D.—(1) Subject to paragraph (2), an EAMS scientific opinion ceases to have effect—

(a)at the end of a period of one year beginning with the date on which it is issued;

(b)on the granting of a marketing authorisation in respect of the product to which the opinion relates (but if the marketing authorisation is to apply in Great Britain only, the opinion can continue to have effect in Northern Ireland and vice versa);

(c)on a variation of an existing marketing authorisation to take account of the advantage, identified in the opinion, because of which the product was included in the Early Access to Medicines Scheme (but if the variation is of a marketing authorisation that applies in Great Britain only, the opinion can continue to have effect in Northern Ireland and vice versa); or

(d)if it is revoked by the licensing authority pursuant to regulation 167C(3).

(2) The licensing authority may provide, in conditions attached in accordance with regulation 167C(2)(c), for a winding down period during which an EAMS scientific opinion is to continue to have effect in specified circumstances or for specified purposes (or both), notwithstanding that it has otherwise ceased to have effect by virtue of paragraph (1).

Textual Amendments

EAMS medicinal products: manufacture, assembly, importation, distribution and supplyU.K.

167E.—(1) The prohibitions in regulation 46 (requirement for authorisation) do not apply in relation to an EAMS medicinal product if—

(a)the medicinal product is supplied in response to an unsolicited order;

(b)the medicinal product is manufactured and assembled in accordance with the specification (of the EAMS medicinal product) of a person who is a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber;

(c)the medicinal product is for use by a patient for whose treatment that person is directly responsible in order to fulfil the special needs of that patient that relate to the advantage identified in the EAMS scientific opinion in respect of the product;

(d)the EAMS scientific opinion issued in respect of the product and has not ceased to have effect in respect of it in accordance with regulation 167D; and

(e)the conditions in paragraphs (2) to (4) are met.

(2) If the EAMS medicinal product is—

(a)manufactured or assembled (wholly or partly) in the United Kingdom, that manufacture or assembly must be—

(i)by the holder of a manufacturer’s licence (which need not relate specifically to the manufacture of special medicinal products) or, if the licensing authority agrees, a manufacturing authorisation (within the meaning given in regulation 36(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004) that relates to the manufacture or assembly of investigational medicinal products, and

(ii)a function permitted by that manufacturer’s licence or manufacturing authorisation;

(b)manufactured or assembled (wholly or partly) in an EEA State and imported into Northern Ireland (whether it is for sale or supply in Northern Ireland or Great Britain), that manufacture or assembly must be—

(i)by a holder of a relevant authorisation in relation to the manufacture or assembly of medicinal products that has effect in accordance with the provisions of the 2001 Directive as implemented in that State, or

(ii)if the medicinal product was manufactured or assembled as an investigational medicinal product in that State, by the holder of a relevant authorisation in relation to the manufacture or assembly of investigational medicinal products that has effect in accordance with the provisions of the EU Clinical Trials Regulation;

(c)manufactured or assembled (wholly or partly) in an approved country for import and imported into Great Britain, that manufacture or assembly must be—

(i)by a holder of a relevant authorisation in relation to the manufacture or assembly of medicinal products that has effect in accordance with the provisions applicable in that country, or

(ii)if the medicinal product was manufactured or assembled as an investigational medicinal product in that country, by the holder of a relevant authorisation in relation to the manufacture or assembly of investigational medicinal products that has effect in accordance with the provisions applicable in that country,

and that importation must be by the holder of a wholesale dealer’s licence that permits importation into Great Britain of the product in question; or

(d)manufactured or assembled (wholly or partly) outside the United Kingdom but sub-paragraph (b) or (c) does not apply to the importation of that product, the importation of that product must be—

(i)by the holder of a manufacturer’s licence that relates to the importation of special medicinal products or, if the licensing authority agrees, investigational medicinal products, and

(ii)a function permitted by that licence.

(3) Written records of the manufacture or assembly of the EAMS medicinal product must be maintained by the manufacturer or assembler and be available to the licensing authority or to the enforcement authority on request.

(4) If the EAMS medicinal product is distributed by way of wholesale dealing by a person (“P”), who has not, as the case may be, manufactured, assembled or imported the product as mentioned in paragraph (2), P must be the holder of a wholesale dealer’s licence that permits distribution of the product in question.

(5) Where, with the agreement of the licensing authority, to ensure the ongoing availability of an EAMS medicinal product, an authorised product is assembled as that EAMS medicinal product and is supplied as part of the Scheme—

(a)that authorised product is to be treated—

(i)as an unauthorised product for the purposes of Part 13, and

(ii)as that EAMS product for the purposes regulations 167G and 167H and Part 11; and

(b)in any circumstances where that supply would not be an off label supply to which the prohibitions in regulation 46(2) did not apply (by operation of the common law), that supply is to be treated as an off label supply to which those prohibitions do not apply.

Textual Amendments

Advertising of EAMS medicinal productsU.K.

167F.—(1) No advertisement relating to an EAMS medicinal product may be published by any person in respect of an advantage identified in the EAMS scientific opinion in respect of the product (although this does not preclude a person promoting the Early Access to Medicine Scheme itself).

(2) In this regulation, “publish” has the meaning given in regulation 277(1) (interpretation: Part 14 advertising).

Textual Amendments

EAMS medicinal products: pharmacovigilanceU.K.

167G.—(1) [F688Subject to paragraphs (1A) and (1B),] the EAMS scientific opinion holder must comply with the following pharmacovigilance requirements in respect of an EAMS medicinal product—

(a)a risk management system must be agreed with the licensing authority and operated by the EAMS scientific opinion holder in accordance with the risk management plan;

(b)the EAMS scientific opinion holder must record and maintain adverse reaction reports in respect of the EAMS medicinal product and must ensure that these reports are accessible (electronically or physically) at a single point within the United Kingdom;

(c)the EAMS scientific opinion holder must submit electronically to the licensing authority—

(i)a report on all serious suspected adverse reactions that occur within 15 days of receipt, and

(ii)a report on all non-serious suspected adverse reactions that occur in the United Kingdom within 90 days of receipt,

and must ensure that the reports referred to in sub-paragraphs (i) and (ii) are in the format and content specified by Part 6 of Schedule 12A [F689and, in the case of an MM medicinal product or a POC medicinal product, include the product’s batch number or other product identifier if no batch number is available];

(d)the EAMS scientific opinion holder must—

(i)establish procedures in order to obtain accurate and verifiable data for the scientific evaluation of suspected adverse reaction reports, and

(ii)collect follow-up information on reports submitted under sub-paragraphs (c)(i) and (c)(ii) and submit it electronically to the licensing authority by way of an update to the original report within the specified time period;

(e)the EAMS scientific opinion holder must submit periodic reports, in the manner specified in conditions attached under regulation 167C(2)(c), on the use of the EAMS medicinal product to the licensing authority, and where reasonably practicable, these reports must contain—

(i)details of any suspected adverse drug reaction to the medicinal product,

(ii)a summary of any significant new data on the quality, safety or efficacy of the medicinal product concerned,

(iii)any proposed updates to the medicinal product information,

(iv)all data the holder has relating to the volume of prescriptions, including an estimate of the population exposed to the medicinal product in the United Kingdom, and

(v)a scientific evaluation of the risk-benefit balance of the medicinal product;

(f)the EAMS scientific opinion holder must notify the licensing authority without delay if it detects any relevant changes in relation to the EAMS medicinal product, and for these purposes, “relevant changes” means—

(i)new risks,

(ii)risks that have changed, and

(iii)changes to the risk-benefit balance; and

(g)the EAMS scientific opinion holder must—

(i)record all pharmacovigilance information required under this regulation,

(ii)maintain those records for at least five years beginning on the date on which the EAMS scientific opinion ceases to have effect in accordance with regulation 167D(1) (subject to any winding down period provided for in accordance with regulation 167D(2)), and

(iii)make those records available to the licensing authority or to the enforcement authority on request.

[F690(1A) In the case of an MM medicinal product, the periods of 15 and 90 days referred to in paragraph (1)(c) begin on the day following the day on which the holder of the scientific opinion gained knowledge of the reaction.

(1B) In the case of a POC medicinal product, the periods of 15 and 90 days referred to in paragraph (1)(c) begin on the day following the day on which the holder of the scientific opinion gained knowledge of the reaction.]

(2) Nothing in paragraph (1) precludes the meeting of the requirements of that paragraph within systems or other arrangements established for other medicinal products (including for an authorised product the marketing authorisation of which may, in due course, be varied to take account of the advantage identified in the EAMS scientific opinion in respect of the EAMS medicinal product).

Textual Amendments

Early Access to Medicines Scheme: data collectionU.K.

167H.—(1) Data may be collected and handled in respect of patients for the purposes of assessing the quality, safety and efficacy of an EAMS medicine as part of the Early Access to Medicines Scheme without the need for an authorisation granted by the licensing authority under the Clinical Trials Regulations, if—

(a)informed consent is obtained from the patient and such consent is evidenced in writing, dated and signed, or otherwise marked by the patient as to indicate their consent; and

(b)the licensing authority has consented to the data collection.

(2) This is without prejudice to—

(a)the need for the EAMS scientific opinion holder to obtain other approvals in respect of the handling of patient data, where appropriate; and

(b)the powers that the EAMS scientific opinion holder and the licensing authority have to handle patient data (in accordance with the requirements of the Data Protection Act 2018) without the patient’s consent.

(3) For the avoidance of doubt, patient consent to data collection or handling is not, and must not be made, a condition of the supply of an EAMS medicinal product to a patient as part of the Early Access to Medicines Scheme.]

Textual Amendments

Use of non-prescription medicines in the course of a businessU.K.

168.—(1) The prohibitions in regulation 46 (requirement for authorisation) do not apply to anything done in relation to a medicinal product if the following conditions are met.

(2) Condition A is that the medicinal product is not a prescription only medicine.

(3) Condition B is that the medicinal product is sold or supplied to a person who is a health care professional (“P”) exclusively for use by P—

(a)in the course of a business carried on by P, and

(b)for the purposes of administering it or causing it to be administered otherwise than by selling it.

(4) Condition C is that the medicinal product is—

(a)manufactured and assembled in accordance with the specification of P; and

(b)for use by a patient for whose treatment P is directly responsible in order to fulfil the special needs of that patient

(5) Condition D is that if sold or supplied through the holder of a wholesale dealer's licence the medicinal product is sold or supplied to such a person and for such use as mentioned in condition B.

(6) Condition E is that no advertisement relating to the medicinal product is published by any person.

(7) Condition F is that the sale or supply of the medicinal product is in response to an unsolicited order.

[F691(8) Condition G is that if the medicinal product is—

(a)manufactured or assembled in the United Kingdom or imported into the United Kingdom from—

(i)in the case of a product for sale or supply in Northern Ireland, a country other than an EEA State, or

(ii)in the case of a product for sale or supply in Great Britain, a country other than an approved country for import,

it is manufactured, assembled or imported by the holder of a manufacturer's licence that relates specifically to the manufacture, assembly or importation of special medicinal products, or

(b)imported into—

(i)Northern Ireland from an EEA State, it is manufactured or assembled in that State by a person who is the holder of an authorisation in relation to its manufacture or assembly in accordance with the provisions of the 2001 Directive as implemented in that State, or

(ii)Great Britain from an approved country for import—

(aa)it is manufactured or assembled in that country by a person who is the holder of an authorisation in that country in relation to its manufacture or assembly, and

(bb)it is imported by the holder of a wholesale dealer's licence under Part 3 that includes the import of a medicinal product from such a country.]

(9) In this regulation “publish” has the meaning given in regulation 277(1) (interpretation: Part 14 advertising).

Textual Amendments

Mixing of general sale medicinal productsU.K.

169.—[F692(A1) This regulation does not apply to an MM medicinal product or a POC medicinal product.]

(1) The prohibitions in regulation 46 (requirement for authorisation) do not apply to a medicinal product (“the product”) in respect of which the following conditions are met.

(2) Condition A is that the product is manufactured by the mixing of authorised medicinal products with other authorised medicinal products, or with substances that are not medicinal products.

(3) Condition B is that any authorised medicinal product that is so mixed is subject to general sale.

(4) Condition C is that the product is manufactured by a person (“H”) who is the holder of a manufacturer's licence that—

(a)relates specifically to the manufacture of medicinal products in accordance with this regulation; and

(b)was granted or renewed not more than five years before the date on which the product is sold or supplied in accordance with paragraphs (5) and (6),

and that the product is manufactured in accordance with the terms of that licence.

(5) Condition D is that the product is sold or supplied by H to a person (“P”) for administration to P or to a member of P's household.

(6) Condition E is that P is present and asks H to use H's judgment as to the treatment required.

(7) Condition F is that no advertisement relating to the product is published by any person.

(8) Condition G is that written records of the manufacture of the product and of the sale or supply of the product are maintained and are made available to the licensing authority or to the enforcement authority on request.

(9) In this regulation, “authorised medicinal product” means a medicinal product that is the subject of—

(a)a [F693UK marketing authorisation F694...];

(b)a certificate of registration; or

(c)a traditional herbal registration.

Textual Amendments

Record-keeping requirementsU.K.

170.—[F695(A1) This regulation does not apply to an MM medicinal product or a POC medicinal product.]

(1) Where the sale or supply of a medicinal product relies on the exemptions under regulations 167, 168 or, subject to paragraph (4), 169, the person who sells or supplies the product must maintain for at least five years a record showing—

(a)the source from which and the date on which the person obtained the product;

(b)the person to whom and the date on which the sale or supply was made;

(c)the quantity of the sale or supply;

(d)the batch number of the batch of that product from which the sale or supply was made; and

(e)details of any suspected adverse reaction to the product so sold or supplied of which the person is aware or subsequently becomes aware.

(2) The person must make the records available for inspection by the licensing authority on request.

(3) The person must notify the licensing authority of any suspected adverse reaction to the medicinal product which is a serious adverse reaction.

(4) In the case of a medicinal product that is sold or supplied in reliance on the exemption in regulation 169—

(a)the reference in paragraph (1)(a) to “the product” means all the medicinal products that were mixed in the course of the manufacture of the product; and

(b)paragraph (1)(d) shall not apply.

Textual Amendments

[F696MM medicinal products: pharmacovigilance requirementsU.K.

170A.—(1) Where the sale or supply of an MM medicinal product relies on the exemption in regulation 167, the person who sells or supplies the product must maintain a record of the information specified in paragraph (2) from the date that sale or supply first takes place until a date that is at least five years from the date on which supply of the product is discontinued.

(2) The following information is specified for the purpose of paragraph (1)—

(a)the source from which, and the date on which, the person obtained the product;

(b)the person to whom, and the date on which, the sale or supply was made;

(c)the quantity of the sale or supply;

(d)the product’s batch number from which the sale or supply was made, or other product identifier if no batch number is available; and

(e)details of any suspected adverse reaction to the product so sold or supplied of which the person is aware or subsequently becomes aware.

(3) The person must make the record available for inspection by the licensing authority on request.

(4) The person must submit electronically to the licensing authority—

(a)a report on all serious suspected adverse reactions to the product that occur within 15 days of the day following the day on which the person gained knowledge of the reaction, and

(b)a report on all non-serious suspected adverse reactions to the product that occur in the United Kingdom within 90 days of the day following the day on which the person gained knowledge of the reaction.

(5) The person must ensure that the reports referred to in paragraph (4)—

(a)are in the format and have the content specified in Part 6 of Schedule 12A; and

(b)include the product’s batch number, or other product identifier if no batch number is available.

(6) The person must, at the written request of the licensing authority, set up a risk management system designed to identify, characterise, prevent or minimise risks relating to the product.

Textual Amendments

POC medicinal products: pharmacovigilance requirementsU.K.

170B.—(1) Where the sale or supply of a POC medicinal product relies on the exemption in regulation 167, the person who sells or supplies the product must maintain a record of the information specified in paragraph (2) from the date that sale or supply first takes place until a date that is at least five years from the date on which supply of the product is discontinued.

(2) The following information is specified for the purpose of paragraph (1)—

(a)the source from which, and the date on which, the person obtained the product;

(b)the person to whom, and the date on which, the sale or supply was made;

(c)the quantity of the sale or supply;

(d)the product’s batch number from which the sale or supply was made, or other product identifier if no batch number is available; and

(e)details of any suspected adverse reaction to the product so sold or supplied of which the person is aware or subsequently becomes aware.

(3) The person must make the record available for inspection by the licensing authority on request.

(4) The person must submit electronically to the licensing authority—

(a)a report on all serious suspected adverse reactions to the product that occur within 15 days of the day following the day on which the person gained knowledge of the reaction, and

(b)a report on all non-serious suspected adverse reactions to the product that occur in the United Kingdom within 90 days of the day following the day on which the person gained knowledge of the reaction.

(5) The person must ensure that the reports referred to in paragraph (4)—

(a)are in the format and have the content specified in Part 6 of Schedule 12A; and

(b)include the product’s batch number, or other product identifier if no batch number is available.

(6) The person must, at the written request of the licensing authority, set up a risk management system designed to identify, characterise, prevent or minimise risks relating to the product.]

Textual Amendments

Exempt advanced therapy medicinal productsU.K.

171.—[F697(A1) This regulation does not apply to an MM medicinal product or a POC medicinal product.]

(1) The prohibitions in regulation 46 (requirement for authorisation) do not apply in relation to an advanced therapy medicinal product (an “exempt advanced therapy medicinal product”) if the following conditions are met.

(2) Condition A is that the product is prepared—

(a)on a non-routine basis;

(b)in the United Kingdom; and

(c)according to specific quality standards equivalent to those provided for advanced therapy medicinal products authorised [F698under regulation 49(1)].

(3) Condition B is that the product is used—

(a)in a hospital in the United Kingdom;

(b)under the exclusive professional responsibility of a doctor; and

(c)in order to comply with an individual medical prescription for a product made to order for an individual patient.

(4) Condition C is that no advertisement relating to the medicinal product is published by any person.

(5) Condition D is that the sale or supply of the medicinal product is in response to an unsolicited order.

(6) In this regulation “publish” has the meaning given in regulation 277(1) (interpretation Part 14 advertising).

Textual Amendments

Parallel import licencesU.K.

172.—(1) The prohibitions in regulation 46 (requirement for authorisation) do not prevent—

(a)the holder of a parallel import licence from placing the medicinal product to which the licence relates on the market; or

(b)the sale or supply, or offer for sale or supply, of a medicinal product to which a parallel import licence relates, in accordance with the terms of that licence.

[F699(2) In this regulation “parallel import licence” has the same meaning as in regulation 48(2).]

Textual Amendments

Exemption for certain radiopharmaceuticalsU.K.

173.  Regulation 46 (requirement for authorisation) does not apply where a radiopharmaceutical is prepared—

(a)at the time when it is intended to be administered;

(b)in accordance with the manufacturer's instructions and by the person by whom it is to be administered;

(c)from radionuclide generators, radionuclide kits and radionuclide precursors in respect of which a [F700UK marketing authorisation F701...] is in force; and

[F702(d)for administration—

(i)in England and Wales and Scotland in accordance with a licence issued under the Ionising Radiation (Medical Exposure) Regulations 2017;

(ii)in Northern Ireland in accordance with a licence issued under the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018.]

Textual Amendments

Supply in response to spread of pathogenic agents etcU.K.

174.  The prohibitions in regulation 46 (requirement for authorisation) do not apply where the sale or supply of a medicinal product is authorised by the licensing authority on a temporary basis in response to the suspected or confirmed spread of—

(a)pathogenic agents;

(b)toxins;

(c)chemical agents; or

(d)nuclear radiation,

which may cause harm to human beings.

[F703Conditions of temporary authorisations under regulation 174U.K.

174A.—(1) Where the sale or supply of a medicinal product is authorised by the licensing authority on a temporary basis under regulation 174, the licensing authority may attach conditions to that authorisation, those being conditions to which the following are subject—

(a)its recommendation or requirement as to the use of that product for the purposes of regulation 345; and

(b)its authorisation of the sale or supply of that product.

(2) The sale or supply of that medicinal product is not authorised by the licensing authority for the purposes of regulation 174 if—

(a)the sale or supply is for the purpose of any use other than the recommended or required use, as mentioned in paragraph (1)(a); or

(b)a condition attached in accordance with paragraph (1) to the authorisation of the sale or supply is breached.

(3) The use of that medicinal product is not in accordance with a recommendation or requirement of the licensing authority for the purposes of regulation 345 if—

(a)a condition attached in accordance with paragraph (1) to the authorisation of its sale or supply is breached; and

(b)any risk of death or personal injury that is wholly or partly attributable to that breach is such that a reasonable person with relevant expertise in the subject matter of the breach would regard the breach as sufficiently serious to justify the licensing authority setting aside the recommendation or requirement.

(4) Notwithstanding paragraph (3), the persons mentioned in regulation 345(3) are not subject to any civil liability resulting from a use of that medicinal product that was (but for the operation of that paragraph) in accordance with the recommendation or requirement of the licensing authority, if those persons were not wholly or partly responsible for the breach in question.

(5) As soon as is reasonably practical after the end of one year beginning on the day on which the first conditions are attached in accordance with paragraph (1), the Secretary of State must—

(a)review the operation of this regulation with a view to evaluating whether there have been any adverse consequences for the market in medicines or for patient safety as a consequence of the operation of this regulation;

(b)set out the conclusions of the review in a report; and

(c)publish the report.]

Textual Amendments

OffencesU.K.

Offences relating to exceptionsU.K.

175.—(1) A person to whom this paragraph applies is guilty of an offence if the person provides to the licensing authority any information that is relevant to the evaluation of the safety, quality or efficacy of a medicinal product that is false or misleading in a material particular.

(2) Paragraph (1) applies to any person who for the purposes of regulation 167 (special patient needs)—

(a)sells or supplies the product; or

(b)provides a specification for the product.

(3) A person is guilty of an offence if the person fails to—

(a)maintain any record required by regulation [F704167G(1)(g)(ii) (EAMS medicinal products: pharmacovigilance)] [F705, 170(1) (records in connection with special medicinal products etc), 170A(1) (MM medicinal products: pharmacovigilance requirements), or 170B(1) (POC medicinal products: pharmacovigilance requirements)];

(b)make any record available as required by regulation [F706167G(1)(g)(iii)] [F707, 170(2), 170A(3) or 170B(3)]; or

(c)notify the licensing authority of any suspected serious adverse reaction as required by regulation 170(3) [F708, 170A(4) or 170B(4)] [F709or of any relevant changes as required by regulation 167G(1)(f)].

Textual Amendments

Penalties and supplementary provision about offencesU.K.

176.—(1) A person guilty of an offence under regulation 175 is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment, to a fine, to imprisonment for a term not exceeding two years or to both.

(2) It is a defence for a person charged with an offence under regulation 175(1) to prove that the person took all reasonable precautions and exercised all due diligence to avoid commission of that offence.

(3) Where evidence is adduced that is sufficient to raise an issue with respect to the defence in paragraph (2), the court or jury must presume that the defence is satisfied unless the prosecution proves beyond reasonable doubt that it is not.

PART 11U.K.Pharmacovigilance

Application of this Part and interpretationU.K.

177.—(1) This Part and Schedule 33 apply, except to the extent set out in paragraph (4)(b), in relation to medicinal products that are the subject of—

(a)a UK marketing authorisation;

(b)a traditional herbal registration; or

(c)an Article 126a authorisation.

[F710(1A) Schedule 12A applies in relation to medicinal products that are the subject of a [F711UKMA(GB), UKMA(UK)(Category 1) or a THR(GB)].]

[F712(1B) Regulations 178 and 179 apply in relation to EAMS medicinal products.]

(2) [F713Except in regulation 191A, references in] this Part [F714and Schedule 12A] to a “holder” are to the holder of—

(a)a UK marketing authorisation;

(b)a traditional herbal registration; or

(c)an Article 126a authorisation,

and, in relation to such references, “product” means the product to which the authorisation or registration relates.

(3) References to an “authorisation or registration” in this Part and in [F715Schedules 12A and 33] are references to—

(a)a UK marketing authorisation;

(b)a traditional herbal registration; or

(c)an Article 126a authorisation

and “authorised or registered” is to be read accordingly.

F716(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) In this Part and in [F717Schedules 33 and 33A]—

“co-ordination group” means the group of that name established under Article 27 of the 2001 Directive;

“Eudravigilance database” means the database and data-processing network set up and maintained by the EMA under Article 24 of Regulation (EC) No 726/2004;

[F718“Implementing Regulation” means Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council.]

“infringement notice” has the meaning given to it in regulation 206 (infringement notices);

“relevant competent authorities” means the competent authority of each EEA state other than the United Kingdom which has granted in relation to a medicinal product—

(a)

an authorisation in accordance with Chapter 1 of Title III to the 2001 Directive (marketing authorization);

(b)

an authorisation in accordance with Chapter 4 of Title III to the 2001 Directive (mutual recognition and decentralised procedure);

(c)

a registration in accordance with Chapter 2a of Title III to the 2001 Directive (traditional use registration for herbal medicinal products); or

(d)

an authorisation in accordance with Article 126a of the 2001 Directive;

“relevant post-authorisation safety study” means a post-authorisation safety study which—

(a)

is non-interventional;

(b)

is initiated, managed or financed by the holder voluntarily or pursuant to conditions imposed under regulation 59 (conditions of a UK marketing authorisation: general) or 61 (conditions of a UK marketing authorisation: new obligations post-authorisation); and

(c)

involves the collection of safety data from patients or health care professionals; F719...

[F720“signal” means, in relation to a UKMA(GB) [F721, UKMA(UK)(Category 1)] or THR(GB), information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, which is judged to be of sufficient likelihood to justify verificatory action; and]

“UK web-portal” has the meaning given in regulation 203 (obligations on licensing authority in relation to national medicines web-portal).

Textual Amendments

F713Words in reg. 177(2) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 19 and words in reg. 177(2) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 19

Obligations on licensing authority in relation to pharmacovigilanceU.K.

General obligations of the licensing authorityU.K.

178.  The licensing authority must—

(a)take all appropriate measures to encourage the reporting to it of suspected adverse reactions;

(b)facilitate reporting through the provision of alternative reporting formats in addition to web-based formats;

(c)take all appropriate measures to obtain accurate and verifiable data for the scientific evaluation of suspected adverse reaction reports;

(d)ensure that the public is given important information on pharmacovigilance concerns relating to the use of a medicinal product in a timely manner, through publication on the UK web-portal, and through other means of publicly available information as necessary; and

(e)ensure that all appropriate measures are taken to identify any biological medicinal product [F722, MM medicinal product and POC medicinal product (including name and batch number or other product identifier if no batch number is available)] prescribed, dispensed or sold in the United Kingdom which is the subject of a suspected adverse reaction report through—

(i)the methods for collecting data, and

(ii)where necessary, the follow up of suspected adverse reaction reports.

Textual Amendments

Obligation on licensing authority to operate pharmacovigilance systemU.K.

179.—(1) The licensing authority must operate a pharmacovigilance system [F723in relation to medicinal products for sale or supply in Great Britain].

[F724(1A) The licensing authority must operate a pharmacovigilance system in relation to medicinal products for sale or supply in Northern Ireland.]

(2) [F725Each pharmacovigilance system] must in particular enable the collection of information on the risks that medicinal products present to patients' health or public health, including information on—

(a)adverse reactions in humans arising from use of a medicinal product (irrespective of whether the use was within the terms of an authorisation or registration); and

(b)adverse reactions associated with occupational exposure.

(3) The licensing authority must on an ongoing basis—

(a)evaluate scientifically the information collected under [F726each pharmacovigilance system];

(b)consider options for minimising and preventing risks presented by medicinal products; and

(c)take appropriate regulatory action, if any.

Textual Amendments

Obligation on licensing authority to audit pharmacovigilance systemU.K.

180.—(1) The licensing authority must perform a regular audit of its pharmacovigilance system [F727relating to medicinal products for sale or supply [F728pursuant to a UKMA(GB) or a UKMA(UK)(Category 1)]] F729....

[F730(1A) The licensing authority must perform a regular audit of its pharmacovigilance system relating to medicinal products for sale or supply in Northern Ireland [F731pursuant to a UKMA(NI) or a UKMA(UK)(Category 2)] and report the results of that audit to the European Commission.]

(2) The F732... audit referred to in paragraph (1) must be [F733performed]—

(a)on the first occasion no later than 21st September 2013; and

(b)every two years after the first occasion.

[F734(3) The results of the audit referred to in paragraph (1A) must be reported to the European Commission—

(a)on the first occasion no later than 21st September 2021;

(b)every two years after the first occasion.]

Textual Amendments

Delegation of obligations under this PartU.K.

181.—(1) The licensing authority may delegate any of its obligations under this Part [F735in connection with its pharmacovigilance system in relation to medicinal products for sale or supply in Northern Ireland [F736pursuant to a UKMA(NI) or a UKMA(UK)(Category 2)] to an EEA State] where the conditions in paragraph (2) are met.

(2) The conditions in this paragraph are that the EEA State to whom the obligations are to be delegated—

(a)has given its written agreement to the delegation; and

(b)is not performing delegated obligations under this Part on behalf of another EEA State.

(3) Where the licensing authority has delegated any of its obligations under paragraph (1), it must—

(a)inform the European Commission, the EMA and all other EEA States in writing of the delegation as soon as is reasonably practicable; and

(b)make the delegation public as soon as is reasonably practicable.

(4) The licensing authority may agree to carry out any of the obligations of another EEA State under Title IX of the 2001 Directive on a delegated basis, but may carry out obligations under that Title only for one EEA State at any time.

Textual Amendments

Obligations on holders in relation to pharmacovigilance systemU.K.

Obligation on holder to operate pharmacovigilance systemU.K.

182.—(1) The holder must operate a pharmacovigilance system.

(2) The holder must (as part of its pharmacovigilance system)—

(a)have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance who resides and operates in the EU [F737or United Kingdom] and is responsible for the establishment and maintenance of the pharmacovigilance system;

(b)maintain and make available on the request of the licensing authority a pharmacovigilance system master file [F738and ensure it is permanently and immediately available for inspection electronically in the United Kingdom at the single point from which the reports referred to in regulation 187(4) are accessible];

(c)operate a risk management system for the product in accordance with the risk management plan (if any) for the product (subject to regulation 183);

(d)monitor the outcome of the risk minimisation measures which are contained in the risk management plan (if any) for the product or which are laid down as conditions of the authorisation of the product under regulations 59 to 61 (conditions of UK marketing authorisation); and

(e)update the risk management system for the product and monitor pharmacovigilance data to determine whether in relation to the product—

(i)there are new risks,

(ii)risks have changed, or

(iii)there are changes to the risk-benefit balance.

[F739(2A) Where the person the holder has permanently and continuously at its disposal under paragraph (2)(a) (“the qualified person”) does not reside and operate in the United Kingdom, the holder must nominate a contact person for pharmacovigilance at a national level who reports to the qualified person, resides and operates in the United Kingdom and has permanent access to the pharmacovigilance system master file.

(2B) Paragraph (2A) has effect from the day twelve months after IP completion day.]

[F740(3) Without prejudice to the requirements set out in regulation 65C and Schedule 10A (variations to a UK marketing authorisation) the holder must keep the licensing authority informed at all times of the name and contact details of—

(a)the appropriately qualified person mentioned in paragraph (2)(a); and

(b)the nominated person mentioned in paragraph (2A).

(3A) The holder must—

(a)ensure that the pharmacovigilance system master file is accessible electronically from the single point within the United Kingdom from which the reports referred to in regulation 187(4) are accessible; and

(b)immediately notify the licensing authority of any change to the single point where the pharmacovigilance system master file may be accessed electronically.]

(4) The holder must use its pharmacovigilance system to—

(a)evaluate scientifically all information relevant to the product;

(b)consider options for minimising and preventing the risk presented by the use of the product; and

(c)take appropriate measures as soon as is reasonably practicable to—

(i)investigate the potential risks of the product,

(ii)communicate the risks, and

(iii)implement actions for minimising and preventing the risks, including updating the risk management system for the product.

(5) Where the licensing authority requests that the pharmacovigilance system master file is made available under paragraph (2)(b), the holder must submit a copy of the pharmacovigilance system master file to the licensing authority before the end of the period of 7 days beginning on the day after the day when the request was made.

F741(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Exception to obligation to operate risk management systemU.K.

183.—(1) The holder is not required to operate a risk management system under regulation 182(2)(c) in relation to a medicinal product which has an authorisation or registration that was granted before 21st July 2012.

(2) The licensing authority may impose an obligation on the holder to operate a risk management system in relation to a medicinal product referred to in paragraph (1) if there are concerns about new or changed risks affecting the risk-benefit balance of that product.

(3) Paragraphs (4) to (6) apply where the licensing authority imposes an obligation to operate a risk management system on the holder under paragraph (2).

(4) The licensing authority must without delay notify the holder in writing of—

(a)the imposition of the obligation;

(b)the justification for the obligation;

(c)the timeframe for submission of the detailed description of the risk management system required under paragraph (8)(a); and

(d)the opportunity to present written observations in accordance with paragraph (5).

(5) Where the holder so requests before the end of the period of thirty days beginning on the day after the receipt by the holder of the notice referred to in paragraph (4), the licensing authority must provide the holder with an opportunity to present written observations in response to the imposition of the obligation within such a time limit as the licensing authority may specify.

(6) Where a holder presents written observations under paragraph (5), the licensing authority must withdraw or confirm the imposition of the obligation under paragraph (2), having regard to the written observations, as soon as is reasonably practicable.

(7) Paragraphs (8) and (9) apply where the licensing authority—

(a)imposes an obligation under paragraph (2) and the holder does not present written obligations under paragraph (5); or

(b)confirms the imposition of the obligation under paragraph (2) pursuant to paragraph (6).

(8) The holder must—

(a)submit to the licensing authority in writing a detailed description of the risk management system which it intends to introduce for the product in accordance with the timeframe set out in the notification under paragraph (4); and

(b)comply with the obligation to operate a risk management system.

(9) Where the imposition relates to a product with a UK marketing authorisation, the licensing authority must vary the authorisation to include the measures to be taken as part of the risk management system as conditions of the authorisation as if they were conditions imposed under regulation 59 (conditions of UK marketing authorisations: general).

Obligation on holder to audit pharmacovigilance systemU.K.

184.—(1) The holder must—

(a)perform a regular audit of its pharmacovigilance system;

(b)place a note concerning the main findings of each audit on the pharmacovigilance system master file on completion of each audit; and

(c)ensure that an appropriate corrective action plan is prepared and implemented as soon as is reasonably practicable after completion of each audit.

(2) The holder may remove the note placed on the pharmacovigilance system master file under paragraph (1)(b) when all the measures in the corrective action plan under paragraph (1)(c) have been fully implemented.

[F742(3) The holder of a UKMA(GB) [F743, UKMA(UK)(Category 1)] or THR(GB) must also comply with the requirements of paragraph 13 of Schedule 12A in relation to auditing the pharmacovigilance system.]

Textual Amendments

Recording, reporting and assessment of pharmacovigilance dataU.K.

Recording obligations on the licensing authorityU.K.

185.  The licensing authority must record all suspected adverse reactions to medicinal products that—

(a)occur in the United Kingdom; and

(b)are reported to it by [F744a holder,] a patient or a patient's carer, a health care professional, a coroner or a procurator fiscal.

Textual Amendments

Reporting obligations on the licensing authorityU.K.

186.—(1) The licensing authority must—

(a)when it receives a suspected adverse reaction report from a person mentioned in regulation 185(b), follow up the report with that person as appropriate;

(b)ensure that reports of suspected adverse reactions in the United Kingdom may be submitted to it, whether by the UK web-portal or by other means;

(c)collaborate with the EMA and the holders of authorisations or registrations in the detection of duplicates of suspected adverse reaction reports;

[F745(d)submit reports of serious suspected adverse reactions in Northern Ireland that it has recorded under regulation 185 in relation to—

(i)a UKMA(NI),

[F746(ii)a UKMA(UK)(Category 2),]

(iii)a THR(NI),

(iv)a THR(UK), or

(v)an Article 126a authorisation,

to the EMA before the end of the period of 15 days beginning on the day following the day on which the report was received; and

(e)submit reports of non-serious suspected adverse reactions in Northern Ireland that it has recorded under regulation 185 in relation to—

(i)a UKMA(NI),

[F747(ii)a UKMA(UK)(Category 2),]

(iii)a THR(NI),

(iv)a THR(UK), or

(v)an Article 126a authorisation,

to the EMA before the end of the period of 90 days beginning on the day following the day on which the report was received.]

(2) Paragraph (3) applies where the licensing authority has received a report of a suspected adverse reaction arising from an error associated with the use of a medicinal product.

(3) The licensing authority must (in addition to meeting the requirements in paragraph (1) in respect of the report) ensure that the report is made available to any statutory body with functions in relation to patient safety within the United Kingdom.

F748(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F749186A.  The licensing authority must collaborate with the World Health Organisation in matters of pharmacovigilance, and must in particular—

(a)take the necessary steps to promptly submit to the World Health Organisation appropriate and adequate information regarding the measures taken in the United Kingdom which may have a bearing on public health protection in other countries; and

(b)make available promptly all suspected adverse reaction reports occurring in the United Kingdom to the World Health Organisation.]

Textual Amendments

Recording obligations on holdersU.K.

187.—(1) Subject to paragraph (2), the holder must record all suspected adverse reactions to the product [F750(including listed NIMAR products in Northern Ireland)] occurring [F751in the United Kingdom or another country] which are brought to its attention irrespective of whether the reaction—

(a)is reported spontaneously by patients or health care professionals; or

(b)occurred in the context of a post-authorisation study.

(2) Paragraph (1) does not apply where the suspected adverse reaction occurred in the context of a clinical trial within the meaning of the Clinical Trials Regulations.

(3) The holder must not refuse to consider reports of suspected adverse reactions to the product received electronically or by any other appropriate means from patients or from health care professionals.

(4) The holder must ensure that reports recorded under paragraph (1) are accessible (electronically or physically) at a single point within the [F752United Kingdom].

Textual Amendments

Reporting obligations on holdersU.K.

188.—(1) [F753Subject to paragraphs (1B) and (1C),] [F754the holder of a UK marketing authorisation, traditional herbal registration or Article 126a authorisation] must in relation to the product [F755(including listed NIMAR products in Northern Ireland)]—

(a)submit electronically to the [F756licensing authority] a report on all serious suspected adverse reactions that occur in the [F757United Kingdom] and [F758countries other than the United Kingdom] before the end of the period of 15 days beginning on the day following the day on which the holder gained knowledge of the reaction;

(b)submit electronically to the [F756licensing authority] a report on all non-serious suspected adverse reactions that occur in the [F759United Kingdom] before the end of the period of 90 days beginning on the day following the day on which the holder gained knowledge of the reaction;

(c)establish procedures in order to obtain accurate and verifiable data for the scientific evaluation of suspected adverse reaction reports;

[F760(ca)in the case of an MM medicinal product or a POC medicinal product, ensure that all appropriate measures are taken to identify the product by batch number, or other product identifier if no batch number is available;]

(d)collect follow-up information on reports submitted under sub-paragraphs (a) or (b) and submit it electronically to the [F756licensing authority] by way of an update to the original report within the specified time period; and

(e)collaborate with the [F761licensing authority] in the detection of duplicates of suspected adverse reaction reports.

[F762(1A) [F763Subject to paragraphs (1B) and (1C),] the holder of [F764a UKMA(UK)(Category 2)], a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation must, in relation to the product—

(a)submit electronically to the Eudravigilance database a report on all serious suspected adverse reactions that occur in the UK and other countries before the end of the period of 15 days beginning on the day [F765following the day] on which the holder gained knowledge of the reaction;

(b)submit electronically to the Eudraviligance database a report on all non-serious suspected adverse reactions that occur in an EEA State or Northern Ireland before the end of the period of 90 days beginning on the day [F766following the day] on which the holder gained knowledge of the reaction;

[F767(ba)in the case of an MM medicinal product or a POC medicinal product, ensure that all appropriate measures are taken to identify the product by batch number, or other product identifier if no batch number is available; ]

(c)collect follow-up information on reports submitted under sub-paragraphs (a) or (b) and submit it electronically to the Eudravigilance database by way of an update to the original report within the specified time period; and

(d)collaborate with the EMA and the competent authorities of the EEA States in the detection of duplicates of suspected adverse reaction reports.]

[F768(1B) In the case of an MM medicinal product, the periods of 15 and 90 days referred to in in paragraphs (1) and (1A) begin on the day following the day on which the holder of the marketing authorisation gained knowledge of the reaction.

(1C) In the case of a POC medicinal product, the periods of 15 and 90 days referred to in paragraphs (1) and (1A) begin on the day following the day on which the holder of the marketing authorisation gained knowledge of the reaction.]

(2) The holder [F769of a UKMA(NI), [F770a UKMA(UK)(Category 2)], a THR(NI), a THR(UK) or an Article 126a authorisation] is not required to submit a report of a suspected adverse reaction to the product under [F771paragraph (1A)(a) or (b)], or to provide follow-up information under [F772paragraph (1A)(c)], where—

(a)the suspected adverse reaction relates to a medicinal product which contains a monitored active substance; and

(b)the suspected adverse reaction is recorded in a monitored publication.

(3) [F773Paragraph (4A)] applies to medicinal products containing a monitored active substance.

(4) The holder must—

(a)monitor medical literature F774... for reports of suspected adverse reactions to the product; and

(b)report suspected adverse reactions identified under sub-paragraph (a) in accordance with paragraph (1).

[F775(4A) The holder of a UKMA(NI), [F776a UKMA(UK)(Category 2)], a THR(NI), a THR(UK) or an Article 126a authorisation must—

(a)monitor medical literature other than the monitored publications for reports of suspected adverse reactions to the product; and

(b)report suspected adverse reactions identified under sub-paragraph (a) in accordance with paragraph (1A).]

(5) In this regulation—

F777...

F777...

“the specified time period” means—

(a)

in the case of serious adverse reactions, the period of 15 days beginning on the day following the day on which the follow up information became known to the holder; and

(b)

in the case of non-serious adverse reactions, the period of 90 days beginning on the day following the day on which the follow up information became known to the holder.

F778(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Signal detectionU.K.

Signal detection: licensing authority obligationsU.K.

189.—(1) The licensing authority must in relation to each medicinal product—

(a)monitor the data [F779that it collects by virtue of operating its pharmacovigilance system under this Part] to determine whether there are any relevant changes;

(b)assess updates to the risk management system for the product;

(c)monitor the outcome of risk minimisation measures contained in the risk management plan (if any); and

(d)monitor the outcome of conditions imposed under [F780regulations 59, 60 and 61] (conditions of UK marketing authorisations) (if any).

(2) [F781In relation to medicinal products subject to a UKMA(UK)(Category 2)] [F782, a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation, the licensing] authority must collaborate with the EMA in carrying out its functions under paragraph (1).

(3) [F783In relation to medicinal products subject to a UKMA(UK)(Category 2)] [F784, a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation, the licensing] authority must inform the bodies specified in paragraph (4) without delay if it detects any relevant changes in relation to a medicinal product.

(4) The bodies specified in this paragraph are—

(a)the EMA; and

(b)the relevant competent authorities.

(5) In this regulation “relevant changes” in relation to a medicinal product means—

(a)new risks;

(b)risks that have changed; or

(c)changes to the risk-benefit balance.

Textual Amendments

Signal detection: holder obligationU.K.

190.—[F785(1) The holder must inform—

(a)the licensing authority, and

(b)in respect of [F786a UKMA(UK)(Category 2)], a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation, the EMA,

without delay if it detects any relevant changes in relation to the product.]

(2) In this regulation, “relevant changes” has the meaning given in regulation 189(5).

Textual Amendments

Periodic Safety Update ReportsU.K.

Obligation on holder to submit periodic safety update reports: general requirementsU.K.

191.—(1) The holder must submit reports known as periodic safety update reports (“PSURs”) in relation to the product to the EMA [F787and the licensing authority [F788in the case of a holder of a UKMA(NI) or a UKMA(UK)(Category 2)] or, in the case of a holder of a UKMA(GB) [F789or a UKMA(UK)(Category 1)], to the licensing authority only,] in accordance with this regulation, or in a case where paragraph (2) applies, in accordance with regulation 192.

(2) This paragraph applies to—

(a)a [F790UK] marketing authorisation granted pursuant to regulations 51 (applications for UK marketing authorisations relating to generic medicinal products) or 54 (application relating to products in well-established medicinal use); or

(b)a traditional herbal registration.

(3) In the following paragraphs of this regulation—

“authorisation” means a UK marketing authorisation or an Article 126a authorisation;

“the holder” means the holder of a UK marketing authorisation or an Article 126a authorisation; and

“product” means a product to which a UK marketing authorisation or Article 126a authorisation relates.

(4) Each PSUR must contain—

(a)summaries of data relevant to the benefits and risks of the product, including results of all studies, with a consideration of their potential impact on the authorisation for the product;

(b)a scientific evaluation of the risk-benefit balance of the product; and

(c)all data relating to the volume of sales of the product and any data the holder has relating to the volume of prescriptions, including an estimate of the population exposed to the product.

[F791(4A) A PSUR in relation to a product authorised under a UKMA(GB) [F792or a UKMA(UK)(Category 1)] must also include the content, and be submitted in the format, specified in Part 8 of Schedule 12A.]

(5) For the purposes of paragraph (4)(b), the scientific evaluation must be based on all available data, including data from clinical trials conducted outside the terms of the authorisation for the product.

(6) Each PSUR must be submitted electronically.

(7) PSURs must be submitted to the EMA [F793and the licensing authority [F794in the case of a holder of a UKMA(NI) or a UKMA(UK)(Category 2)] or, in the case of a holder of a UKMA(GB) [F795or a UKMA(UK)(Category 1)], to the licensing authority only,] with the frequency and on the dates as set out in paragraphs (8) to (10).

(8) In the case of an authorisation granted on or after 21st July 2012, the holder must submit PSURs with the frequency as specified in the authorisation for the product, with the dates of submission being calculated from the date of authorisation.

[F796(8A) In the case of a conditional marketing authorisation in relation to a product authorised under a UKMA(GB) [F797or a UKMA(UK)(Category 1)], the holder must submit PSURs immediately upon the request of the licensing authority and at least every six months beginning with the date on which the authorisation for the medicinal product is granted or renewed by the licensing authority.]

(9) In the case of an authorisation granted before 21st July 2012 which specifies the frequency and dates of submission of PSURs, the holder must submit PSURs with the frequency and on the dates as specified in the authorisation for the product.

(10) In the case of an authorisation granted before 21st July 2012 which does not specify the frequency and dates of submission of PSURs, the holder must submit a PSUR—

(a)immediately upon the request of the licensing authority;

[F798(b)where—

(i)in relation to a product authorised under a UKMA(NI) or [F799UKMA(UK)(Category 2)], the product has not yet been placed on the market within the EEA or Northern Ireland, at least every six months following authorisation until the placing on the market within the EEA or Northern Ireland, or

(ii)in relation to a product authorised under a UKMA(GB) [F800or a UKMA(UK)(Category 1)], the product has not yet been placed on the market in [F801the United Kingdom], at least every six months following authorisation until the placing on the market within [F801the United Kingdom]; and]

[F802(c)where—

(i)in relation to a product authorised under a UKMA(NI) or [F803UKMA(UK)(Category 2)], the product has been placed on the market within the EEA or Northern Ireland—

(aa)at least every six months during the first two years following the initial placing on the market,

(bb)once a year for the following two years, and

(cc)every three years after that;

(ii)[F804in relation to a product authorised under a UKMA(GB) or a UKMA(UK)(Category 1), the product has been placed on the market in the United Kingdom]—

(aa)at least every six months during the first two years following the initial placing on the market,

(bb)once a year for the following two years, and

(cc)every three years after that.]

F805(11) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F806Obligation on holder of a parallel import licence to submit periodic safety update reportsU.K.

191A.—(1) The holder of a parallel import licence must submit reports known as periodic safety update reports (“PSURs”) to the licensing authority if notified to do so by the licensing authority.

(2) Each PSUR must contain—

(a)summaries of data relevant to the benefits and risks of the product, including results of all studies, with a consideration of their potential impact on the licence for the product;

(b)a scientific evaluation of the risk-benefit balance of the product; and

(c)all data relating to the volume of sales of the product and any data the holder of the licence has relating to the volume of prescriptions, including an estimate of the population exposed to the product.

(3) For the purposes of paragraph (2)(b), the scientific evaluation must be based on all available data, including data from clinical trials conducted outside the terms of the authorisation for the product.

(4) Each PSUR must be submitted electronically.

(5) The PSUR must be submitted to the licensing authority within the period specified by that authority.]

Textual Amendments

Obligation on holder to submit periodic safety update reports: derogation from general requirementsU.K.

192.—(1) This regulation applies in relation to medicinal products granted—

(a)a [F807UK] marketing authorisation pursuant to regulations 51 (applications for UK marketing authorisations relating to generic medicinal products) or 54 (application relating to products in well-established medicinal use); or

(b)a traditional herbal registration.

(2) In the following paragraphs of this regulation—

“authorisation or registration” means a marketing authorisation to which paragraph (1)(a) applies or a traditional herbal registration;

“the holder” means the holder of a marketing authorisation to which paragraph (1)(a) applies or of a traditional herbal registration; and

“product” means a product to which a marketing authorisation referred to in paragraph (1)(a) or a traditional herbal registration relates.

(3) The holder must submit PSURs in relation to the product to the EMA [F808and the licensing authority [F809in the case of a holder of a UKMA(NI) or a UKMA(UK)(Category 2)] or, in the case of a holder of a UKMA(GB) [F810or a UKMA(UK)(Category 1)], to the licensing authority only,] in accordance with paragraph (5)—

(a)where requested to do so by the licensing authority in accordance with paragraph (4); or

(b)in the case of a product to which paragraph (1)(a) applies, where it is a condition to which the marketing authorisation for the product is subject by virtue of regulations 59 (conditions of UK marketing authorisation: general) or 60 (conditions of UK marketing authorisation: exceptional circumstances) to do so.

(4) The licensing authority may request the holder to submit PSURs where—

(a)it has concerns relating to the product's pharmacovigilance data; or

(b)it considers there is a lack of PSUR data relating to an active substance of the product after the authorisation or registration is granted.

(5) The submission of PSURs under paragraph (3) must be in accordance with—

(a)where the PSUR is submitted pursuant to a request under paragraph (3)(a), the terms of the request; and

(b)where the PSUR is submitted pursuant to a condition under paragraph (3)(b), the terms of the condition.

(6) Each PSUR must contain—

(a)summaries of data relevant to the benefits and risks of the product, including results of all studies, with a consideration of their potential impact on the authorisation or registration for the product;

(b)a scientific evaluation of the risk-benefit balance of the product; and

(c)all data relating to the volume of sales of the product and any data the holder has relating to the volume of prescriptions, including an estimate of the population exposed to the product.

(7) For the purposes of paragraph (6)(b), the scientific evaluation must be based on all available data, including data from clinical trials conducted outside the terms of the authorisation or registration for the product.

(8) Each PSUR must be submitted electronically.

(9) Where the licensing authority requests submission of PSURs under paragraph (3)(a) [F811from the holder of a [F812UKMA(UK)(Category 2)], UKMA(NI), THR(UK), THR(NI) or Article 126a authorisation], it must communicate a PSUR assessment report to the EMA as soon as is reasonably practicable after each report is received.

(10) In this regulation “PSUR assessment report” means a report which evaluates the information provided in a PSUR.

(11) This regulation is subject to regulation 212 (transitional arrangements).

Textual Amendments

Harmonisation of PSUR frequency or date of submissionU.K.

193.—[F813(1) Where products that are subject to different authorisations or registrations contain the same active substance or the same combination of active substances, the frequency and dates of submission may be amended and harmonised in accordance with—

(a)Article 107c(4) of the 2001 Directive, where—

(i)any of the authorisations or registrations is a UKMA(NI), [F814UKMA(UK)(Category 2)], THR(NI), THR(UK) or Article 126a authorisation; and

(ii)none of the authorisations or registrations is a UKMA(GB) [F815, UKMA(UK)(Category 1)] or THR(GB); or

(b)paragraphs (2A), (3) and (4A), where—

(i)any of the authorisations or registrations is a UKMA(GB) [F816, UKMA(UK)(Category 1)] or THR(GB); and

(ii)none of the authorisations or registrations is a UKMA(NI), [F817UKMA(UK)(Category 2)], THR(NI), THR(UK) or Article 126a authorisation.]

(2) The holder [F818of a UKMA(NI), [F819UKMA(UK)(Category 2)], THR(NI), THR(UK) or Article 126a authorisation] may, where one or more of the grounds in paragraph (3) is met, submit a request in relation to the product to the EMA—

(a)to determine an EU reference date; or

(b)to change the frequency of submission of the PSUR.

[F820(2A ) Where one or more of the grounds in paragraph (3) is met, the holder of a UKMA(GB) [F821, UKMA(UK)(Category 1)] or THR(GB) may submit a request in writing to the licensing authority, or the licensing authority may in any event decide, to—

(a)determine a UK reference date from which submission dates are calculated in respect of products that fall under paragraph (1); or

(b)change the frequency and date of submission of the PSUR.]

(3) The grounds in this paragraph are—

(a)reasons relating to public health;

(b)in order to avoid duplication of the assessment; or

(c)in order to achieve international harmonisation.

(4) The second paragraph of Article 107c(6) of the 2001 Directive has effect in relation to the submission and determination of a request under paragraph (2).

[F822(4A) Where the licensing authority makes a decision under paragraph (2) following a written request from a holder of a UKMA(GB) [F823UKMA(UK)(Category 1)] or THR(GB), it must notify that holder in writing of its decision to approve or refuse the request.]

(5) Where the frequency or dates of submission of a PSUR are changed in accordance with Article 107c(4) or Article 107c(6) of the 2001 Directive [F824or paragraph (2A) (as the case may be)], the holder must apply to vary the product's authorisation or registration to reflect the new frequency or date of submission before the end of the period of six months beginning on the day after the change is made public by the EMA [F825or licensing authority (as the case may be)].

(6) In this regulation, “EU reference date” in relation to a product means—

(a)the date of the first marketing authorisation in the EEA of a medicinal product containing the same active substance or the same combination of active substances as that product; or

(b)if the date referred to in point (a) cannot be ascertained, the earliest of the known dates of the marketing authorisations in the EEA for a medicinal product containing the same active substance or the same combination of active substances as that product.

[F826(6A) Subject to paragraph (6B), in this regulation, “UK reference date” means a date determined by the licensing authority under paragraph (2)(a) in respect of medicinal products containing the same active substance or the same combination of active substances.

(6B) Until the licensing authority makes a decision under paragraph (2), any—

(a)Union reference date in respect of medicinal products containing the same active substance or the same combination of active substances; or

(b)date of submission and frequency of periodic safety reports in respect of such products,

published by the EMA under Article 107c(7) of the 2001 Directive, is deemed to be the UK reference date or, as the case may be, the required date or frequency of PSUR submission, in respect of those medicinal products.]

[F827(7) The licensing authority must publish a list of—

(a)UK reference dates it determines under paragraph (2); and

(b)the required date of submission and frequency for PSURs in respect of medicinal products containing the same active substance or the same combination of active substances.

(8) Any change to the date of submission and frequency of PSURs as a result of the application of this regulation is to take effect after a 6 month period, such period beginning with the day after the licensing authority publishes that change under paragraph (7).]

Textual Amendments

Responding to a single assessment of PSUR under Article 107e of the 2001 DirectiveU.K.

194.—(1) This regulation applies where PSURs relating to a medicinal product [F828authorised under a UKMA(NI), [F829UKMA(UK)(Category 2)], THR(NI), THR(UK) or Article 126a authorisation] have been assessed under the EU single assessment procedure.

(2) The licensing authority must implement—

(a)the necessary measures that are consequent upon any agreement reached under Article 107g(2) of the 2001 Directive as part of the EU single assessment process, in accordance with the implementation timetable determined in the agreement; or

(b)any decision adopted under Article 107g(4)(a) of the 2001 Directive before the end of the period of 30 days beginning on the day after the day on which the licensing authority received notification of the decision.

(3) Paragraph (4) applies where—

(a)an agreement reached under Article 107g(2) of the 2001 Directive requires a variation to be made to an authorisation or registration; and

(b)the terms of the agreement are known to the holder of that authorisation or registration.

(4) A holder of an authorisation or registration referred to in paragraph (3)(a) must submit to the licensing authority in accordance with the implementation timetable determined in the agreement an appropriate application for a variation, including—

(a)an updated summary of the product characteristics; and

(b)an updated package leaflet.

(5) In this regulation, “EU single assessment procedure” means the single assessment procedure laid down in Article 107e of the 2001 Directive, which covers—

(a)medicinal products that are authorised in more than one member State; and

(b)medicinal products that contain the same active substance or the same combination of active substances and for which a harmonised EU reference date and frequency of submission of PSURs have been established under Article 107c of the 2001 Directive.

Textual Amendments

Obligation on licensing authority to assess PSURs F830...U.K.

195.— [F831(A1) This regulation applies in the circumstances specified in paragraphs (1) and (1A).]

(1) This regulation applies where PSURs relating to a medicinal product [F832authorised for sale or supply authorised under a UKMA(NI), [F833UKMA(UK)(Category 2)], THR(NI), THR(UK) or Article 126a authorisation] have not been assessed under the EU single assessment procedure because—

[F834(a)the medicinal product to which the PSUR relates—

(i)has not been authorised to be placed on the market in accordance with the 2001 Directive in an EEA State F835...; and

(ii)a harmonised EU reference date and frequency of submission of PSURs have not been established for that product under Article 107c of the 2001 Directive; or

(b)the medicinal product is one that is imported into the UK under a parallel import licence.]

[F836(1A) This regulation applies where PSURs relating to a medicinal product authorised for sale or supply under a UKMA(GB) [F837, UKMA(UK)(Category 1)] or THR(GB) have been submitted to the licensing authority under regulations 191 to 192.]

(2) The licensing authority must assess the PSURs to determine whether there are any relevant changes.

(3) Where the licensing authority has assessed a PSUR under paragraph (2) it must—

(a)consider whether any action concerning the authorisation or registration of the product to which the PSUR relates is necessary; and

(b)vary, suspend, or revoke the authorisation or registration as appropriate.

[F838(3A) If the licensing authority considers under paragraph (3)(b) that an authorisation or registration needs to be varied, it may require the holder to submit to the licensing authority, within a time period that the licensing authority specifies, an application for a variation, including—

(a)an updated summary of the product characteristics; and

(b)an updated package leaflet.]

(4) In this regulation—

“EU reference date” has the meaning given in regulation 193(6);

“EU single assessment procedure” has the meaning given in regulation 194(5); and

“relevant changes” in relation to a medicinal product means—

(a)

new risks,

(b)

risks that have changed, or

(c)

changes to the risk-benefit balance.

Textual Amendments

F834Reg. 195(1)(a)(b) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 21 and reg. 195(1)(a)(b) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 21

Urgent action [F839and major safety review] U.K.

Textual Amendments

Urgent actionU.K.

196.—[F840(1) [F841In the case of a medicinal product authorised for sale or supply under a UKMA(NI), [F842UKMA(UK)(Category 2)], THR(NI), THR(UK) or Article 126a authorisation, the licensing authority must inform] the specified bodies where, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities,—

(a)it considers suspending or revoking an authorisation or registration of a medicinal product or class of medicinal products;

(b)it considers prohibiting the supply of a medicinal product or class of medicinal products;

(c)it considers refusing the renewal of an authorisation or registration of a medicinal product; or

(d)it is informed by a holder that, on the basis of safety concerns, the holder has—

(i)interrupted the sale or supply, or offer of sale or supply, of the product,

(ii)taken action to have the product’s authorisation or registration cancelled or intends to do so, or

(iii)not applied for the renewal of the product’s authorisation or registration.

(2) The licensing authority must inform the specified bodies where, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, it considers it necessary to vary an authorisation or registration or a class of authorisations or registrations to include—

(a)a new contra-indication,

(b)a reduction to the recommended dose, or

(c)a restriction to the therapeutic indications.

(2A) The information provided under paragraph (2) must outline the action considered and the reasons for the action.

F843(2B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2C) The information required to be provided under paragraph (1) or (2) must be provided by the end of the day on which the consideration arose under paragraph (1)(a) to (c) or (2) or the information was received under paragraph (1)(d) (as the case may be).]

(3) When informing the EMA under paragraph [F844(1) or] (2), the licensing authority must make available to the EMA in relation to the medicinal product or class of medicinal products—

(a)all relevant scientific information at its disposal; and

(b)any assessment it has carried out.

F845(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F845(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F845(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F845(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F846(8) In this regulation—

F847...

F847...

“specified bodies” means—

(a)

the competent authority of each EEA State other than the United Kingdom,

(b)

the EMA, and

(c)

the European Commission.]

Textual Amendments

F840Reg. 196(1)-(2C) substituted for reg. 196(1) (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 7(2)

[F848Major safety review by the licensing authorityU.K.

196A.—(1) The licensing authority may conduct a major safety review where—

(a)on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities it considers—

(i)suspending or revoking a UK marketing authorisation or traditional herbal registration of a medicinal product or in respect of a class of medicinal products,

(ii)prohibiting the supply of a medicinal product or a class of medicinal products,

(iii)refusing the renewal of a UK marketing authorisation or traditional herbal registration, or

(iv)action is necessary to vary a UK marketing authorisation or traditional herbal registration or a class of such authorisations or registrations, including to impose new conditions; or

(b)it is informed by a holder that, on the basis of safety concerns, the holder has—

(i)interrupted the sale or supply, or offer of sale or supply, of the product to which a UK marketing authorisation or traditional herbal registration relates,

(ii)taken action to have that product's authorisation or registration cancelled or intends to do so, or

(iii)not applied for the renewal of that product's authorisation or registration.

(2) If the licensing authority conducts a review under paragraph (1), it must—

(a)announce the initiation of that review on the UK web-portal as soon as reasonably practicable;

(b)include in that announcement—

(i)an outline of its reasons for conducting a major safety review, the medicinal products concerned and, where applicable, the active substances concerned, and

(ii)the proposed structure and time-scale of the review;

(c)notify a holder if the product to which that holder's authorisation or registration relates is within the scope of the review; and

(d)publish the outcome of that review, including any recommendations it is making, or action it is proposing to take, as soon as reasonably practicable after the conclusion of that review.

(3) A holder who is notified under paragraph (2)(c)—

(a)must provide to the licensing authority such information as the licensing authority notifies that holder it requires, within such time period as the licensing authority specifies; and

(b)may, where such information contains confidential data relevant to the subject matter of the review, because the data relates to a manufacturing process or trade secret, notify the licensing authority that that data is provided in confidence.

(4) Where the licensing authority proposes that action should be taken in respect of any UK marketing authorisation or traditional herbal registration—

(a)during the conduct of the major safety review, because urgent action is necessary to protect public health; or

(b)upon the conclusion of such a review,

it may exercise its powers under Part 5 or 7 (as the case may be) in relation to that authorisation or registration.]

Textual Amendments

EU urgent action procedureU.K.

197.—(1) Where the EU urgent action procedure is initiated in relation to a medicinal product or class of medicinal products [F849authorised for sale or supply under a UKMA(NI), [F850UKMA(UK)(Category 2)], THR(NI), THR(UK) or Article 126a authorisation], the licensing authority—

(a)may publicly announce the initiation of the EU urgent action procedure on the UK web-portal; and

(b)must implement the measures set out in any agreement reached under Article 107k of the 2001 Directive in relation to the medicinal product or class of medicinal products in accordance with the implementation timetable determined in the agreement.

(2) Paragraph (3) applies where an agreement under Article 107k of the 2001 Directive in relation to a medicinal product or class of medicinal products requires a variation to be made to one or more authorisation or registration.

(3) Each holder of an authorisation or registration covered by the agreement referred to in paragraph (2) must submit to the licensing authority in accordance with the terms of the agreement (including its implementation timetable) an application for a variation in respect of the authorisation or registration including—

(a)an updated summary of the product characteristics; and

(b)an updated package leaflet.

(4) In this regulation, “EU urgent action procedure” has the same meaning as it is given in regulation 196(8).

Textual Amendments

Post-authorisation safety studiesU.K.

Post-authorisation safety studies: general provisionsU.K.

198.—(1) A relevant post-authorisation safety study—

(a)may not be conducted where the act of conducting the study promotes the use of a medicinal product; and

(b)may not provide for payments to health care professionals for participating in the study except in compensation for time and expenses incurred.

(2) The licensing authority may require the holder for the product which is the subject of a relevant post-authorisation safety study to submit the protocol and progress reports for the study to

[F851(a)]the competent authorities of the EEA States in which the study is conducted [F852and the licensing authority, where the product is subject to a [F853UKMA(UK)(Category 2), UKMA(UK)(NI)], traditional herbal registration or Article 126a authorisation for sale or supply in Northern Ireland;]

[F854(b)the licensing authority, where the product is subject to a [F855UKMA(UK)(Category 1), a UKMA(GB)] or traditional herbal registration for sale or supply in Great Britain only.]

(3) The holder for the product which is the subject of a relevant post-authorisation safety study must—

(a)comply with a requirement imposed by the licensing authority under paragraph (2) (if any);

(b)while the study is being conducted—

(i)monitor the data generated, and

(ii)consider its implications for the risk-benefit balance of the product which is the subject of the study;

(c)communicate to

[F856(i)the relevant competent authorities and the licensing authority, where paragraph (2)(a) applies;

(ii)the licensing authority where paragraph (2)(b) applies,]

[F857any new information that arises at any point during the study which might influence the evaluation of the risk-benefit balance for that product as soon as is reasonably practicable after it becomes known to the holder; and]

(d)send the final report on the study to

[F858(i) the competent authorities of the EEA States in which the study was conducted [F859and the licensing authority, where paragraph (2)(a) applies;]]

[F860(ii)the licensing authority, where paragraph (2)(b) applies,]

[F861before the end of the period of 12 months beginning on the day after the day on which data collection for the study ended.]

(4) This regulation is subject to regulation 212 (transitional arrangements).

Textual Amendments

F851Words in reg. 198(2) renumbered as reg. 198(2)(a) (31.12.2020) by S.I. 2019/775, reg. 158(2)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(a))

F856Reg. 198(3)(c)(i)(ii) substituted for words in reg. 198(3)(c) (31.12.2020) by S.I. 2019/775, reg. 158(3)(a)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(b)(i))

F858Words in reg. 198(3)(d) renumbered as reg. 198(3)(d)(i) (31.12.2020) by S.I. 2019/775, reg. 158(3)(b)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(b)(ii))

Submission of draft study protocols for required studiesU.K.

199.—(1) This regulation applies to a relevant post-authorisation safety study that is to be conducted pursuant to a condition of a UK marketing authorisation imposed under regulation 59 (conditions of a UK marketing authorisation: general) or 61 (conditions of a UK marketing authorisation: new obligations post-authorisation).

(2) The holder for the product which is the intended subject of the study must submit a draft protocol for the study [F862to—

(a)the body specified in paragraph (3) and the licensing authority (where not otherwise required by paragraph (3)), where the authorisation is a UKMA(NI) or [F863UKMA(UK)(Category 2)];

(b)the licensing authority, where the authorisation is a UKMA(GB) [F864or UKMA(UK)(Category 1)],

before the study is commenced.]

(3) The body specified in this paragraph is—

(a)where the study is to be conducted in the United Kingdom only, the licensing authority; or

(b)in all other cases [F865where the study is to be conducted in the EU or an EEA State], the Pharmacovigilance Risk Assessment Committee.

(4) Paragraph (5) applies where a draft protocol is submitted [F866only] to the licensing authority under paragraphs (2) and (3)(a) [F867(and is not submitted to the Pharmacovigilance Risk Assessment Committee)].

(5) Where this paragraph applies, the licensing authority, before the end of the period of 60 days beginning on the day after the day on which the draft protocol is submitted, must issue—

(a)a letter endorsing the draft protocol;

(b)a letter objecting to the draft protocol on the grounds that—

(i)it considers that the conduct of the study promotes the use of a medicinal product, or

(ii)it considers that the design of the study does not fulfil the study objectives; or

(c)a letter notifying the holder for the product which is the intended subject of the study that the study is a clinical trial within the meaning of the Clinical Trials Regulations.

(6) A study may not commence unless a letter endorsing the draft protocol has been issued by—

(a)the licensing authority under paragraph (5)(a); or

(b)the Pharmacovigilance Risk Assessment Committee under Article 107n(2) of the 2001 Directive.

(7) Paragraph (8) applies where a letter endorsing the draft protocol has been issued by the Pharmacovigilance Risk Assessment Committee under Article 107n(2) of the 2001 Directive.

(8) Where this paragraph applies, the holder for the product which is the intended subject of the study must forward the protocol to the competent authorities of the EEA States in which the study is to be conducted before commencing the study.

(9) In this regulation, “a letter” includes email correspondence.

(10) This regulation is subject to regulation 212 (transitional arrangements).

Textual Amendments

F862Reg. 199(2)(a)(b) substituted for words in reg. 199(2) (31.12.2020) by S.I. 2019/775, reg. 159(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 127(a))

Amendment to study protocols for required studiesU.K.

200.—(1) This regulation applies where a study to which regulation 199 applies has been commenced.

(2) The holder for the product which is the subject of the study must submit any substantial amendments to the study protocol [F868to—

(a)the body specified in paragraph (3) and the licensing authority (where not otherwise required by paragraph (3)), where the authorisation for the product is a UKMA(NI) or [F869UKMA(UK)(Category 2)];

(b)the licensing authority, where the authorisation for the product is a UKMA(GB) [F870or UKMA(UK)(Category 1)],

before their implementation.]

(3) The body specified in this paragraph is—

(a)where the study is being conducted in the United Kingdom only, the licensing authority; or

(b)[F871where the study is being conducted in the EU or an EEA State], the Pharmacovigilance Risk Assessment Committee.

(4) Paragraph (5) applies where a proposed amendment to a study protocol is submitted [F872only] to the licensing authority under paragraphs (2) and (3)(a) [F873(and is not submitted to the Pharmacovigilance Risk Assessment Committee)].

(5) Where this paragraph applies, the licensing authority must as soon as is reasonably practicable—

(a)assess the amendment; and

(b)inform the holder of its endorsement of, or objection to, the proposed amendment.

(6) Paragraph (7) applies where the proposed amendment to a study protocol is submitted to the Pharmacovigilance Risk Assessment Committee under paragraphs (2) and (3)(b).

(7) Where this paragraph applies, the holder who submitted the amendment must inform the competent authorities of the EEA States in which the study is being conducted of any amendment to the study protocol approved by the Pharmacovigilance Risk Assessment Committee as soon as is reasonably practicable.

(8) This regulation is subject to regulation 212 (transitional arrangements).

Textual Amendments

F868Reg. 200(2)(a)(b) substituted for words in reg. 200(2) (31.12.2020) by S.I. 2019/775, reg. 160(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 128(a))

Submission and evaluation of final study reports for required studiesU.K.

201.—(1) This regulation applies where a study to which regulation 199 applies has been completed.

(2) Subject to paragraph (4), the holder for the product which is the subject of the study must submit electronically, before the end of the period of 12 months beginning on the day after the day on which data collection for the study ended, [F874to—

(a)the body specified in paragraph (3) and the licensing authority (where not otherwise required by paragraph (3)), where the authorisation for the product is a UKMA(NI) or [F875UKMA(UK)(Category 2)];

(b)the licensing authority, where the authorisation for the product is a UKMA(GB) [F876or UKMA(UK)(Category 1)],

a final study report and an abstract of the study results.]

(3) The body specified in this paragraph is—

(a)where the study was conducted in the United Kingdom only, the licensing authority; or

(b)[F877where the study was conducted in the EU or an EEA State], the Pharmacovigilance Risk Assessment Committee.

(4) Paragraph (2) does not apply where a written waiver has been granted by the licensing authority F878..., or by the Pharmacovigilance Risk Assessment Committee F878....

(5) The holder must without delay—

(a)evaluate whether the results of a final study report submitted under paragraph (2) have an impact on the authorisation or registration of the medicinal product to which the report relates; and

(b)if necessary, submit an application to vary the authorisation or registration for the product.

(6) This regulation is subject to regulation 212 (transitional arrangements).

Textual Amendments

F874Reg. 201(2)(a)(b) substituted for words in reg. 201(2) (31.12.2020) by S.I. 2019/775, reg. 161(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 129(a))

Follow-up of final study reportsU.K.

202.—(1) This regulation applies [F879in respect of a UKMA(NI), [F880UKMA(UK)(Category 2)], THR(NI), THR(UK) or Article 126a authorisation] where—

(a)the Pharmacovigilance Risk Assessment Committee has made recommendations concerning an authorisation or registration or a class of authorisations or registrations based on a final study report under Article 107q(1) of the 2001 Directive; and

(b)an agreement on the action to be taken in respect of the authorisation or registration or the class of authorisations or registrations has been reached by the co-ordination group under the procedure laid out in Article 107q(2) of the 2001 Directive (“the agreement”).

(2) The licensing authority must implement the measures set out in the agreement in accordance with the implementation timetable determined in the agreement.

(3) Paragraph (4) applies where—

(a)the agreement requires a variation to be made to one or more authorisation or registration; and

(b)the terms of the agreement are known to the holder or holders for the product or products which is, or which are, the subject of the agreement.

(4) Where this paragraph applies, each holder must submit to the licensing authority in accordance with the terms of the agreement (including its implementation timetable) an application for a variation including—

(a)an updated summary of the product characteristics; and

(b)an updated package leaflet.

(5) This regulation is subject to regulation 212 (transitional arrangements).

Textual Amendments

[F881Medicinal products subject to additional monitoringU.K.

Textual Amendments

Licensing authority power in relation to medicinal products subject to additional monitoringU.K.

202A.—(1) The licensing authority may establish a list of medicinal products that are subject to additional monitoring.

(2) The list referred to in paragraph (1) is to include the names and active substances of—

(a)medicinal products authorised in the United Kingdom that contain a new active substance which, on 1st January 2011, was not contained in any medicinal product authorised in the United Kingdom;

(b)any biological medicinal product not covered by sub-paragraph (a) that was authorised in the United Kingdom after 1st January 2011;

(c)medicinal products that are authorised pursuant to these Regulations, subject to the conditions referred to in regulation 50I, 59(2)(b) or (c), 60 or 61(4);

[F882(d)any MM medicinal product;

(e)any POC medicinal product.]

(3) If the licensing authority considers it appropriate, medicinal products that are authorised pursuant to these Regulations, subject to the conditions referred to in regulation 59(2)(a), (d), (e) or (f), 61(5) or 183(2), may also be included in the list referred to in paragraph (1).

(4) For medicinal products included in the list referred to in paragraph (1)—

(a)the summary of product characteristics and the package leaflet must include a symbol and statement as follows: “▼ This medicinal product is subject to additional monitoring”; and

(b)that symbol must be proportional to the font of the subsequent standardised text, and each side of the triangle must have a minimum length of 5 millimetres.

(5) In the cases referred to in paragraph (2)(a) and (b), the licensing authority must, unless paragraph (6) applies, remove a medicinal product from the list after five years, beginning with the day after the UK reference date referred to in regulation 193.

(6) In the cases referred to in paragraph (2)(c) and (3), the licensing authority must remove a medicinal product from the list once the condition or obligation under a provision specified in those paragraphs has been fulfilled.

(7) Until the licensing authority publishes a list of medicinal products under paragraph (1), the reference to that list is instead to be read as a reference to the list referred to in Article 23 of Regulation (EC) No 726/2004, as that list may be amended from time to time.]

Textual Amendments

Transparency and communicationsU.K.

Obligations on licensing authority in relation to national medicines web-portalU.K.

203.—(1) The licensing authority must set up and maintain a national medicines web-portal (“the UK web-portal”) F883...

(2) The licensing authority must make available publicly by means of the UK web-portal the following (at a minimum)—

(a)the assessment reports prepared or revised by the licensing authority under regulation 64(5) and (6) (duties of licensing authority in connection with determination), each with a summary;

(b)the summary of the product characteristics for the medicinal products concerned;

(c)the package leaflet for the medicinal products concerned;

(d)a summary of the risk management plan (if any) for the medicinal products concerned;

[F884(da)the list published by the licensing authority under, or which applies by virtue of, regulation 202A;]

(e)the list of medicinal products that are subject to additional monitoring referred to in Article 23 of Regulation (EC) No 726/2004; and

(f)information on the different ways of reporting suspected adverse reactions to medicinal products to the licensing authority by patients or their carers, health care professionals, coroners or procurators fiscal (including by way of the web-based structured forms referred to in Article 25 of Regulation (EC) No 726/2004).

Textual Amendments

Obligation on licensing authority in relation to public announcementsU.K.

204.—(1) This regulation applies where the licensing authority intends to make a public announcement relating to information on pharmacovigilance concerns [F885which relate to products authorised under a UKMA(NI) or [F886UKMA(UK)(Category 2)]].

(2) Subject to paragraph (4), the licensing authority must inform the bodies specified in paragraph (3) not less than 24 hours prior to making the public announcement.

(3) The bodies specified in this paragraph are—

(a)the EMA;

(b)the European Commission; and

(c)the competent authority of each EEA State other than the United Kingdom.

(4) Paragraph (2) does not apply if the information in the announcement needs to be made public urgently for the protection of public health.

Textual Amendments

Obligations on holders in relation to public announcementsU.K.

205.—(1) This regulation applies where the holder intends to make a public announcement relating to information on pharmacovigilance concerns in relation to the use of a medicinal product.

(2) The holder must inform the bodies listed in paragraph (3) [F887where the product is subject to a UKMA(NI), [F888UKMA(UK)(Category 2)], THR(NI), THR(UK) or Article 126a authorisation, or the licensing authority where the product is subject to a UKMA(GB) [F889, UKMA(UK)(Category 1)] or THR(GB),] of its intention to make the public announcement—

(a)as soon as is practicable once it forms that intention; and

(b)in any event no later than at the same time as, or before, the public announcement is made.

(3) The bodies listed in this paragraph are—

(a)the licensing authority;

(b)the EMA; and

(c)the European Commission.

(4) The holder must ensure that the information in the public announcement—

(a)is presented objectively; and

(b)is not misleading.

Textual Amendments

[F890Further obligations in respect of pharmacovigilance activitiesU.K.

Textual Amendments

Further obligations in respect of pharmacovigilance activitiesU.K.

205A.—(1) Schedule 12A applies in relation to medicinal products for sale or supply under a UKMA(GB) [F891, UKMA(UK)(Category 1)] or THR(GB) and makes further provision as to the obligations of a holder and the licensing authority in respect of the performance of pharmacovigilance activities under this Part.

(2)  The Secretary of State may by regulations F892... amend Schedule 12A.

(3) Regulations under paragraph (2) may make provision regarding the performance of pharmacovigilance activities under this Part as to—

(a)the content and maintenance of the pharmacovigilance system master file kept by the holder;

(b)the minimum requirements for the quality system for the performance of pharmacovigilance activities by the holder and the licensing authority;

(c)the use of internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities;

(d)the minimum requirements for the monitoring of data recorded by the licensing authority pursuant to regulation 185 (recording obligations on the licensing authority) to determine whether there are new risks or whether risks have changed;

(e)the format and content of electronic transmission of suspected adverse reactions by a holder;

(f)the format and content of electronic periodic safety reports and risk management plans; and

(g)the format of protocols, abstracts and final study reports for the post-authorisation safety studies.]

Textual Amendments

[F893Guidance in respect of pharmacovigilanceU.K.

Textual Amendments

Guidance in respect of good pharmacovigilance practice and post authorisation efficacy studiesU.K.

205B.—(1) The licensing authority may publish—

(a)guidance on good pharmacovigilance practices for both the licensing authority and UK marketing authorisation holders;

(b)scientific guidance on post authorisation efficacy studies.

(2) Subject to paragraph (3), the guidance issued by the Commission under Article 108a of the 2001 Directive on the matters specified in paragraph (1)(a) and (b) continues to apply until the date on which the licensing authority publishes guidance under paragraph (1).

(3) The licensing authority—

(a)may determine that provisions of the guidance specified in paragraph (2) no longer apply, or apply subject to specified modifications, from a date that it specifies; and

(b)must, if it so determines, publish its determination.

(4) Guidance published under paragraph (1), or which applies by virtue of paragraph (2) (as modified by any determination under paragraph (3), as the case may be), is to be taken into account in consideration of whether there has been any failure to comply with a provision in this Part, or Schedule 12A, to which the guidance is relevant.]

EnforcementU.K.

Infringement noticesU.K.

206.—[F894(1) If an enforcement authority has objective grounds for considering that any person (“P”) has contravened any relevant provision, it may serve upon P a notice in writing (referred to in this Part as an “infringement notice”)—

(a)informing P of the authority’s grounds for considering that P has contravened one or more relevant provision;

(b)specifying the relevant provision;

(c)specifying the measures which P must take in order to ensure that the contravention does not continue or, as the case may be, does not recur;

(d)requiring P to take those measures, within such period as may be specified in the notice;

(e)specifying the further action (if any) that the enforcement authority may take.]

(2) An infringement notice may include directions as to the measures to be taken by P to ensure that the contravention does not continue or, as the case may be, does not recur, including the different ways of securing compliance.

(3) If an enforcement authority serves an infringement notice in accordance with paragraph (1) [F895in relation to a product authorised for sale or supply under a UKMA(NI), [F896UKMA(UK)(Category 2)], THR(NI) or THR(UK)], it shall as soon as is reasonably practicable inform—

(a)the EMA; and

(b)the European Commission.

[F897(4) In this regulation “relevant provision” means a provision of—

(a)this Part;

[F898(aa)Schedule 12A;]

(b)Chapter 3 of Title II of Regulation (EC) No 726/2004; or

(c)the Implementing Regulation.]

Textual Amendments

OffencesU.K.

207.—(1) A person is guilty of an offence if the person commits a breach of a provision in this Part, other than [F899Schedule 12A (further requirements in respect of pharmacovigilance activities) and] regulation 199(2) or (6) (submission of draft study protocols for required studies).

(2) A breach of a provision in this Part includes any—

(a)failure by a holder to comply with any requirement or obligation in this Part; or

(b)contravention by any person of any prohibition in this Part.

Textual Amendments

False and misleading informationU.K.

208.  A person is guilty of an offence if the person provides information to the licensing authority or the EMA, pursuant to an obligation in this Part, but that information is false or misleading in a material particular.

PenaltiesU.K.

209.—(1) Subject to paragraph (2), a person guilty of an offence under regulation 207 or 208 is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment to a fine, to imprisonment for a term not exceeding two years or to both.

(2) A person guilty of an offence under regulation 207 which relates to a breach of a provision listed in paragraph (3) is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment to a fine.

(3) Those provisions are regulations—

(a)182(2)(a) and (b), (3) and (5);

(b)183(8)(a);

(c)184(1)(a) and (b);

(d)187(4);

(e)188(1)(c) and (e);

(f)193(5);

(g)198(1) and (3)(a) and (d);

(h)199(8); and

(i)200(7).

Offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004U.K.

F900210.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F901Offences in relation to pharmacovigilance obligations under the Implementing Regulation [F902and Schedule 12A] U.K.

210A.—(1) A holder is guilty of an offence if the holder—

(a)[F903in relation to a UKMA(NI), [F904UKMA(UK)(Category 2)], THR(NI) THR(UK) or Article 126a authorisation,] fails to comply with any requirement or obligation contained in a provision of the Implementing Regulation listed in paragraph (2); or

[F905(aa)in relation to a UKMA(GB) [F906, UKMA(UK)(Category 2)] or THR(GB), fails to comply with any requirement or obligation contained in a provision of Schedule 12A listed in paragraph (2A); or]

(b)provides information which is false or misleading in a material particular to the licensing authority or the EMA pursuant to an obligation in the Implementing Regulation.

(2) The provisions mentioned in paragraph (1)(a) are—

(a)Chapter I (pharmacovigilance system master file);

(b)Sections 1 and 2 of Chapter II (minimum requirements for the quality systems for the performance of pharmacovigilance activities);

(c)Chapter III (minimum requirements for the monitoring of data in the Eudravigilance database);

(d)Chapter V (transmission of reports of suspected adverse reactions);

(e)Article 32 of Chapter VI (updates of risk management plans);

(f)Chapter VII (periodic safety update reports); and

(g)Chapter VIII (post-authorisation safety studies).

[F907(2A) The provisions of Schedule 12A mentioned in paragraph [F908(1)(aa)] are—

(a)Part 1 (pharmacovigilance system master file);

(b)Parts 2 and 3 (minimum requirements for the quality systems in the performance of pharmacovigilance activities);

(c)Part 6 (transmission of reports of suspected adverse reactions);

(d)paragraph 24 (update of risk management plans);

(e)Part 8 (periodic safety update reports); and

(f)Part 9 (post-authorisation safety studies).]

(3) Subject to paragraph (4), a person guilty of an offence under this regulation is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment to a fine.

(4) A person guilty of an offence under this regulation which relates to a breach of Article 34(5) or 36(3) of the Implementing Regulation [F909, or of paragraph 26(8) or 29(1) of Schedule 12A,] is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment to a fine, to imprisonment for a term not exceeding two years or to both.]

Textual Amendments

Persons liableU.K.

211.  If an offence under regulation 207(1) (offences) F910... is committed by a person acting as employee or agent, the employer or principal of that person is guilty of the same offence and is liable to be proceeded against and punished accordingly.

Textual Amendments

Transitional arrangementsU.K.

Transitional arrangementsU.K.

212.  Regulations F911... 198, 199, 200, 201, 202 and 210 are subject to the transitional provisions set out in Schedule 33 (transitional arrangements: pharmacovigilance).

Textual Amendments

PART 12U.K.Dealings with medicinal products

Modifications etc. (not altering text)

CHAPTER 1U.K.Interpretation

InterpretationU.K.

213.—(1) In this Part—

[F912“approved country health professional” means a person who is practising in a profession included in the list published under regulation 214(6A) in a country that is included in that list in relation to that profession;]

F913...

“the Common Services Agency” means the Common Services Agency for the Scottish Health Service established under section 10 of the National Health Service (Scotland) Act 1978 M35;

F914...

“the dental care professionals register” means the register established and maintained under section 36B of the Dentists Act 1984 M36;

[F915“Council Directive 2005/36/EC” means Council Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications;]

F916...

F917...

F918...

“food” includes—

(a)

beverages;

(b)

confectionery;

(c)

articles and substances used as ingredients in the preparation of food; and

(d)

any manufactured substance—

(i)

to which there has been added any vitamin, and

(ii)

which is advertised as available and for sale to the general public as a dietary supplement;

“health authority” means—

(a)

F919...

(b)

in relation to Wales, a Local Health Board established under section 11 of the National Health Service (Wales) Act 2006 M37;

(c)

in relation to Scotland, a Health Board constituted under section 2(1)(a) of the National Health Service (Scotland) Act 1978 M38; and

(d)

in relation to Northern Ireland, [F920the Department of Health in Northern Ireland];

“health care” means services for or in connection with the prevention, diagnosis or treatment of disease;

“health prescription” means a prescription issued by a doctor, dentist, supplementary prescriber, nurse independent prescriber, optometrist independent prescriber, [F921pharmacist independent prescriber, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber] [F922, paramedic independent prescriber] or community practitioner nurse prescriber under—

(a)

in England, the National Health Service Act 2006;

(b)

in Wales, the National Health Service (Wales) Act 2006;

(c)

in Scotland, the National Health Service (Scotland) Act 1978; and

(d)

in Northern Ireland, the Health and Personal Social Services (Northern Ireland) Order 1972 M39;

F923...

“independent clinic”—

(a)

in relation to England, means an establishment of either of the following kinds—

(i)

a walk-in centre, in which one or more medical practitioners provides services of a kind which, if provided in pursuance of the National Health Services Act 2006, would be provided as primary medical services under Part 4 of that Act, or

(ii)

a surgery or consulting room in which a medical practitioner who provides no services in pursuance of the National Health Services Act 2006 provides medical services of any kind (including psychiatric treatment), except where such medical services are provided only under arrangements made on behalf of the patients by—

(aa)

their employer,

(bb)

a government department or any executive agency of any government department,

(cc)

a prison or other establishment in which patients are held under custody, other than pursuant to any provision under the Mental Health Act 1983 M40, or

(dd)

an insurance provider with whom the patients hold an insurance policy, other than an insurance policy which is solely or primarily intended to provide benefits in connection with the diagnosis or treatment of physical or mental illness, disability or infirmity,

and where two or more medical practitioners use different parts of the same premises as a surgery or consulting room, or use the same surgery or consulting room at different times, each of the medical practitioners shall be regarded as carrying on a separate independent clinic unless they practise together;

(b)

in relation to Wales, has the meaning given by section 2(4) of the Care Standards Act 2000 M41;

(c)

in relation to Scotland, has the meaning given by section 10F(2) of the National Health Service (Scotland) Act 1978 M42; and

(d)

in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 M43;

“independent hospital”—

(a)

in relation to England, means a hospital as defined by section 275 of the National Health Service Act 2006 that is not a health service hospital as defined by that section;

(b)

in relation to Wales, has the meaning given by section 2(2) of the Care Standards Act 2000;

(c)

in relation to Scotland, has the meaning given by section 10F(2) of the National Health Act 1978; and

(d)

in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;

“independent medical agency”—

(a)

in relation to England, means an undertaking (not being an independent hospital) which consists of or includes the provision of services by medical practitioners, and the term “undertaking” in this definition includes any business or profession and—

(i)

in relation to a public or local authority includes the exercise of any functions of that authority, and

(ii)

in relation to any other body of persons, whether corporate or unincorporated, includes any of the activities of that body;

(b)

in relation to Wales, has the meaning given by section 2(5) of the Care Standards Act 2000;

(c)

in relation to Scotland means an undertaking which is neither an independent clinic nor an undertaking comprised in a hospital and which consists of or includes the provision of services, other than in pursuance of the National Health Service (Scotland) Act 1978, by a medical practitioner; and

(d)

in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;

[F924“integrated care board” means an integrated care board established under Chapter A3 of Part 2 of the National Health Service Act 2006;]

[F925“local authority” has the same meaning as in section 2B of the National Health Service Act 2006;]

[F926“Maritime and Coastguard Agency” means the executive agency of that name of the Department for Transport;]

“maximum daily dose” or “MDD”, in relation to a product for internal use, means the maximum quantity of the substance contained in the amount of the product that it is recommended should be taken or administered in any period of 24 hours;

“maximum dose” or “MD”, in relation to a product for internal use, means the maximum quantity of the substance contained in the amount of the product that it is recommended should be taken or administered at any one time;

“NHS body” means—

(a)

the Common Services Agency;

(b)

a health authority;

(c)

a special health authority;

(ca)

[F927an integrated care board];

(cb)

[F928NHS England];

(d)

F929...

(e)

an NHS trust; or

(f)

an NHS foundation trust;

“NHS foundation trust” has the meaning given by section 30(1) of the National Health Service Act 2006;

“NHS trust”—

(a)

in relation to England, means an NHS trust established under section 25(1) of the National Health Service Act 2006;

(b)

in relation to Wales, means an NHS trust established under section 18(1) of the National Health Service (Wales) Act 2006;

(c)

in relation to Scotland, means an NHS trust established under section 12A of the National Health Service (Scotland) Act 1978 M44; and

(d)

in relation to Northern Ireland, means a Health and Social Care trust established under Article 10 of the Health and Personal Social Services (Northern Ireland) Order 1991 M45;

“nursing home” has the meaning given by article 11 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 M46;

“parenteral administration” means administration by breach of the skin or mucous membrane;

“patient group direction” or “PGD” means a written direction that relates to the sale or supply and to the administration of a description or class of medicinal product and that—

(a)

is signed—

(i)

by a doctor or dentist and by a pharmacist, and

(ii)

by any other person who may be required to sign it in the circumstances specified for its use in any provision of this Part; and

(b)

relates to sale or supply and to administration to persons generally (subject to any exclusions that may be specified in the PGD);

F930...

“prison service” means—

(a)

in relation to England and Wales, a Minister of the Crown exercising functions in relation to prisons (within the meaning of the Prison Act 1952 M47);

(b)

in relation to Scotland, the Scottish Ministers exercising functions in relation to prisons (within the meaning of the Prisons (Scotland) Act 1989 M48); and

(c)

in relation to Northern Ireland, the Department of Justice exercising functions in relation to prisons (within the meaning of the Prison Act (Northern Ireland) 1953 M49);

[F931“product subject to special medical prescription” means a prescription only medicine that has been designated as subject to special medical prescription in accordance with paragraph (3);]

[F932“Public Health Agency” means the Regional Agency for Public Health and Social Well-being established by section 12 of the Health and Social Care (Reform) Act (Northern Ireland) 2009;

F933...]

“registered chiropodist” means a person who is registered in Part 2 of the Health and Care Professions Council register;

“registered dental hygienist” means a person registered under that title in the dental care professionals register;

“registered dental therapist” means a person registered under that title in the dental care professionals register;

F934...

“registered dispensing optician” means a person whose name is entered in the register of dispensing opticians maintained under section 7(b) of the Opticians Act 1989 M50 or the register of visiting dispensing opticians from relevant European States maintained under section 8B(1)(b) M51 of that Act;

“registered occupational therapist” means a person who is registered in Part 6 of the Health and Care Professions Council register;

“registered orthoptist” means a person who is registered in Part 7 of the Health and Care Professions Council register;

“registered orthotist and prosthetist” means a person who is registered in Part 10 of the Health and Care Professions Council register;

[F935“registered pharmacy technician” means a person registered in Part 2 of the Register of pharmacists and pharmacy technicians established and maintained under article 19(1) and (2) of the Pharmacy Order 2010;]

F936...

F937...

F938...

“registered provider”—

(a)

in England, in relation to an independent hospital, independent clinic, an independent medical agency, a dental clinic or a dental practice means the person who is registered as a service provider under Chapter 2 of Part 1 of the Health and Social Care Act 2008 M52 in respect of regulated activities (within the meaning of that Part) carried on in that hospital, clinic, agency, dental clinic or dental practice;

(b)

in Wales, in relation to an independent hospital, an independent clinic or an independent medical agency, means the person who is registered under Part 2 of the Care Standards Act 2000 as the person who carries on the hospital, clinic or agency;

(c)

in Scotland, in relation to an independent hospital, an independent clinic or an independent medical agency, means the person who is registered under section 10P of the National Health Service (Scotland) Act 1978 M53; and

(d)

in Northern Ireland, in relation to an independent hospital, an independent clinic, a nursing home or an independent medical agency, means the person who is registered under Part 3 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the person who carries on the hospital, clinic, nursing home or agency;

F939...

“registered speech and language therapist” means a person who is registered in Part 12 of Health and Care Professions Council register;

“relevant manager”—

(a)

in England, means—

(i)

a person, other than the registered provider, who is registered under Chapter 2 of Part 1 of the Health and Social Care Act 2008 as the manager of an independent hospital, independent clinic, an independent medical agency, a dental clinic or a dental practice, or

(ii)

if there is no such person, but the registered provider has appointed a person to manage the hospital, clinic, agency, dental clinic or dental practice, that person;

(b)

in Wales, means—

(i)

a person, other than the registered provider, who is registered under Part 2 of the Care Standards Act 2000 as the manager of an independent hospital, an independent clinic or an independent medical agency, or

(ii)

if there is no such person, but the registered provider has appointed a person to manage the hospital, clinic or agency, that person;

(c)

in Scotland, means a person, other than the registered provider, who was identified as an individual who is to manage an independent hospital, an independent clinic or an independent medical agency on the application for registration of that clinic, hospital or agency under section 10P of the National Health Service (Scotland) Act 1978; and

(d)

in Northern Ireland, means—

(i)

a person, other than the registered provider, who is registered under Part 3 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the manager of an independent hospital, an independent clinic, a nursing home or an independent medical agency, or

(ii)

if there is no such person, but the registered provider has appointed a person to manage the hospital, clinic, nursing home or agency, that person;

“relevant prescriber” means any of the following—

(a)

a doctor;

(b)

a dentist;

(c)

a supplementary prescriber;

(d)

a nurse independent prescriber;

(e)

a pharmacist independent prescriber;

(f)

a community practitioner nurse prescriber;

(fa)

[F940a physiotherapist independent prescriber;

(fb)

a podiatrist independent prescriber;

(fc)

a therapeutic radiographer independent prescriber;]

(fd)

[F941a paramedic independent prescriber;]

(g)

an optometrist independent prescriber; and

(h)

an [F942approved country health professional];

“repeatable prescription” means a prescription that contains a direction that it may be dispensed more than once;

[F943“school” means—

(a)

a maintained school (as defined in section 20(7) of the School Standards and Framework Act 1998);

(b)

a maintained nursery school (as defined in section 22(9) of the School Standards and Framework Act 1998);

(c)

an independent school (as defined in section 463 of the Education Act 1996) entered on a register of independent schools kept under section 158 of the Education Act 2002;

(d)

an independent educational institution (as defined in section 92(1) of the Education and Skills Act 2008) entered on a register of independent educational institutions kept under section 95 of that Act;

(e)

a school approved under section 342 of the Education Act 1996 (non-maintained special schools);

(f)

a pupil referral unit (as defined in section 19 of the Education Act 1996);

(g)

an alternative provision Academy (as defined in section 1C(3) of the Academies Act 2010);

(h)

a school as defined in section 135(1) of the Education (Scotland) Act 1980; and

(i)

a school as defined in Article 2(2) of the Education and Libraries (Northern Ireland) Order 1986.]

“sell” means sell by retail (and “sale” has a corresponding meaning);

“special health authority” means—

(a)

in relation to England, a Special Health Authority established under section 28 of the National Health Service Act 2006;

(b)

in relation to Wales, a Special Health Authority established under section 22 of the National Health Service (Wales) Act 2006;

(c)

in relation to Scotland, a Special Health Board constituted under section 2(1)(b) of the National Health Service (Scotland) Act 1978 M54; and

(d)

in relation to Northern Ireland, a special health and social care agency established under Article 3 of the Health and Personal Social Services (Special Agencies) (Northern Ireland) Order 1990 M55;

“supply” means supply in circumstances corresponding to retail sale;

“unit preparation” means a preparation, including a mother tincture, that—

(a)

is prepared by a process of—

(i)

solution,

(ii)

extraction, or

(iii)

trituration,

with a view to being diluted tenfold or one hundredfold, either once or repeatedly, in an inert dilutent; and

(b)

is used—

(i)

in that diluted form, or

(ii)

where applicable, by impregnating tablets, granules, powders or other inert substances,

for the purpose of being administered to human beings.

[F944“vaccine group direction” means a written direction that relates to the supply and administration of a vaccine and that—

(a)

is signed by any person who may be required to sign it in the circumstances specified for its use in regulation 235A; and

(b)

relates to supply and to administration to eligible persons in accordance with regulation 235A (subject to any exclusions that may be specified in the vaccine group direction).]

[F945“the United Kingdom Health Security Agency” means the executive agency of that name of the Department of Health and Social Care.]

(2) In this Part—

(a)a reference to a product being sold or supplied for the purpose of being administered in accordance with the written directions of a doctor or dentist relating to a person includes a reference to it being supplied in accordance with such directions; and

(b)a reference to a product being sold or supplied for the purpose of being administered in accordance with a patient group direction includes a reference to it being supplied in accordance with a patient group direction.

[F946(3) In this Part any substance or product for the time being specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations 2001 or in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations (Northern Ireland) 2002 is designated as a product subject to special medical prescription.]

Textual Amendments

F914Words in reg. 213(1) omitted (E.W.S.) (31.3.2014) by virtue of The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 4(a)(i) and words in reg. 213(1) omitted (N.I.) (31.3.2014) by virtue of The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 4(a)(i)

F915Words in reg. 213(1) inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 4(a)(ii) and words in reg. 213(1) inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 4(a)(ii)

F917Words in reg. 213(1) omitted (E.W.S.) (31.3.2014) by virtue of The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 4(a)(iv) and words in reg. 213(1) omitted (N.I.) (31.3.2014) by virtue of The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 4(a)(iv)

F918Words in reg. 213(1) omitted (1.10.2017) by virtue of The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 6 and words in reg. 213(1) omitted (N.I.) (1.10.2017) by virtue of The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 6

F921Words in reg. 213(1) substituted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 8(2)(a) and words in reg. 213(1) substituted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 8(2)(a)

F922Words in reg. 213(1) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 5(2)(a) and words in reg. 213(1) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 5(2)(a)

F926Words in reg. 213(1) inserted (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 3(2)(a) and words in reg. 213(1) inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 3(2)(a)

F931Words in reg. 213(1) inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 4(a)(v) and words in reg. 213(1) inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 4(a)(v)

F932Words in reg. 213(1) inserted (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 3(2)(b) and words in reg. 213(1) inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 3(2)(b)

F934Words in reg. 213(1) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 8(2)(b) and words in reg. 213(1) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 8(2)(b)

F936Words in reg. 213(1) omitted (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 5(2)(b) and words in reg. 213(1) omitted (N.I.) (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 5(2)(b)

F937Words in reg. 213(1) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 8(2)(c) and words in reg. 213(1) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 8(2)(c)

F938Words in reg. 213(1) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 8(2)(d) and words in reg. 213(1) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 8(2)(d)

F939Words in reg. 213(1) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 8(2)(e) and words in reg. 213(1) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 8(2)(e)

F940Words in reg. 213(1) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 8(2)(f) and words in reg. 213(1) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 8(2)(f)

F941Words in reg. 213(1) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 5(2)(c) and words in reg. 213(1) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 5(2)(c)

F943Words in reg. 213(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 22(b) and words in reg. 213(1) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 22(b)

Marginal Citations

M351978 c.29. Section 10(1) was amended by the Health Services Act 1980 (1980 c.53), Schedule 6 paragraph 2. There are other amendments not relevant to these Regulations.

M361984 c.24. Section 36B was inserted by S.I. 2005/2011, articles 2(1) and 29.

M381978 c.29. Section 2(1)(a) was amended by section 28(a)(i) of the National Health Service and Community Care Act 1990 (1990 c.19) and section 14(2) of, and paragraph 1 of Schedule 7 to, the Health and Social Services and Social Security Adjudications Act 1983 (1983 c.41).

M421978 c.29. Section 10F was inserted by section 108 of the Public Services Reform (Scotland) Act 2010 (2010 asp 8).

M441978 c.29. Section 12A was inserted by section 31 of the National Health Service and Community Care Act 1990 (1990 c.19), and amended by section 46(1)(a) of the Health Act 1999 (1999 c.8).

M45S.I. 1991/194 (N.I. 1), Health and Social Services trusts were renamed Health and Social Care trusts by section 1(3) of the Health and Social Care (Reform) Act (Northern Ireland) 2009 (2009 c.1 (N.I.)). There are other amendments not relevant to this regulation.

M46References to a nursing home in these Regulations concern Northern Ireland only.

M491953 c.18 (N.I.). Functions transferred by article 6(1) of, and Schedule 4 to, S.I. 2010/976.

M501989 c.44; section 7 was amended by S.I. 2005/848, articles 2 and 7(1).

M51Section 8B was inserted by S.I. 2007/3101, regulations 178 and 180.

M531978 c.29. Section 10P was inserted by section 108 of the Public Services Reform (Scotland) Act 2010 (2010 asp 8).

M54Section 2(1)(b) was inserted by section 28(a) of the National Health Service and Community Care Act 1990 (1990 c.19).

M55S.I. 1990/247 (N.I. 3). Special Health and Social Services Agencies were renamed Special Health and Social Care Agencies by section 1(4) of the Health and Social Care (Reform) Act (Northern Ireland) 2009 (2009 c.1 (N.I.)).

CHAPTER 2U.K.Sale and supply of medicines

Prescription only medicinesU.K.

Sale or supply of prescription only medicinesU.K.

214.—(1) A person may not sell or supply a prescription only medicine except in accordance with a prescription given by an appropriate practitioner.

(2) A person may not parenterally administer (otherwise than to himself or herself) a prescription only medicine unless the person is—

(a)an appropriate practitioner other than an [F947approved country health professional]; or

(b)acting in accordance with the directions of such an appropriate practitioner.

(3) The following are appropriate practitioners in relation to any prescription only medicine—

(a)a doctor;

(b)a dentist;

(c)a supplementary prescriber;

(d)a nurse independent prescriber; and

(e)a pharmacist independent prescriber.

(4) A community practitioner nurse prescriber is an appropriate practitioner in relation to a prescription only medicine specified in Schedule 13.

(5) An optometrist independent prescriber is an appropriate practitioner in relation to any prescription only medicine other than—

(a)a medicinal product that is a [F948product subject to special medical prescription]; or

(b)a medicinal product that is for parenteral administration.

[F949(5A) A podiatrist independent prescriber is an appropriate practitioner in relation to any prescription only medicine unless that medicinal product contains a [F950product subject to special medical prescription] other than—

(a)Dihydrocodeine: or

(b)Temazepam.

(5B) A physiotherapist independent prescriber is an appropriate practitioner in relation to any prescription only medicine unless that medicinal product contains a [F951product subject to special medical prescription] other than—

(a)Dihydrocodeine;

(b)Fentanyl;

(c)Morphine;

(d)Oxycodone; or

(e)Temazepam.]

[F952(5C) A therapeutic radiographer independent prescriber is an appropriate practitioner in relation to any prescription only medicine unless that medicinal product contains a product subject to special medical prescription other than—

(a)Codeine;

(b)Fentanyl;

(c)Midazolam;

(d)Morphine;

(e)Oxycodone;

(f)Temazepam; or

(g)Tramadol.]

[F953(5D) A paramedic independent prescriber is an appropriate practitioner in relation to any prescription only medicine unless that medicinal product contains a product subject to special medical prescription other than—

(a)Codeine;

(b)Fentanyl;

(c)Midazolam; or

(d)Morphine.]

(6) An [F954approved country health professional] is an appropriate practitioner in relation to any prescription only medicine other than a [F955product subject to special medical prescription].

[F956(6A) The licensing authority must publish a list of approved countries and professions for the purposes of the definition of “approved country health professional”.

(6B) In order to determine whether a country or profession should be included in the list published under paragraph (6A), the licensing authority may, in particular, take into account—

(a)the country's standards of professional qualification;

(b)the country's system for ensuring that qualified professionals have undergone training which meets the requirements that apply in that country;

(c)the effectiveness of enforcement of professional standards;

(d)the mechanisms the country has in place to assist members of the public in obtaining information in respect of a qualified professional who is established there; and

(e)the regularity and rapidity of information provided by that country relating to non-compliant professionals.

(6C) The licensing authority must—

(a)review a country or profession it has included in the list published under paragraph (6A) to determine if it is still satisfied that they should remain on the list, and if it is not so satisfied, remove it from that list; and

(b)undertake such a review at least every 3 years beginning with the date on which that country or profession was included in that list.]

(7) This regulation is subject to Chapter 3 (exemptions).

Textual Amendments

F948Words in reg. 214(5)(a) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(a) and words in reg. 214(5)(a) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(a)

F950Words in reg. 214(5A) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(a) and words in reg. 214(5A) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(a)

F951Words in reg. 214(5B) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(a) and words in reg. 214(5B) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(a)

F952Reg. 214(5C) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 9 and reg. 214(5C) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 9

F955Words in reg. 214(6) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(a) and words in reg. 214(6) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(a)

Prescribing and administration by supplementary prescribersU.K.

215.—(1) A supplementary prescriber (“S”) may not give a prescription for a prescription only medicine unless S meets conditions A and C.

(2) A supplementary prescriber (“S”) may not—

(a)parenterally administer a prescription only medicine; or

(b)give directions for the parenteral administration of a prescription only medicine,

unless S meets conditions B and C.

(3) Condition A is that S is acting in accordance with the terms of a clinical management plan that—

(a)relates to the patient to whom the product is prescribed;

(b)has effect when the prescription is given; and

(c)includes the particulars specified in Schedule 14.

(4) Condition B is that S is acting in accordance with the terms of a clinical management plan that—

(a)relates to the patient to whom the product is, or is to be, administered;

(b)has effect when the product is administered or (as the case may be) the direction is given; and

(c)includes the particulars specified in Schedule 14.

(5) Condition C is that S has access to health records that—

(a)are the health records of the patient to whom the plan relates; and

(b)are used by any doctor or dentist who is a party to the plan.

(6) This regulation is subject to regulation 216.

(7) In this regulation—

“clinical management plan” means a written plan (which may be amended from time to time) relating to the treatment of an individual patient agreed by—

(a)

the patient to whom the plan relates;

(b)

the doctor or dentist who is a party to the plan; and

(c)

any supplementary prescriber who is to prescribe, give directions for administration or administer under the plan;

“health record” has the meaning given by section 68(2) of the Data Protection Act 1998 M56.

Marginal Citations

Exceptions to regulation 215U.K.

216.—(1) Regulation 215 does not apply if—

(a)S is a community practitioner nurse prescriber; and

(b)the prescription only medicine prescribed or administered, or in respect of which S gives directions for administration, is specified in Schedule 13.

(2) Regulation 215(2) does not apply if S is acting in accordance with the directions of another person who is an appropriate practitioner (other than a supplementary prescriber or an [F957approved country health professional]) in relation to the prescription only medicine in question.

Textual Amendments

Requirements for prescriptions: generalU.K.

217.—(1) For the purposes of this Chapter, a prescription only medicine is not sold or supplied in accordance with a prescription given by an appropriate practitioner unless the following conditions are met.

(2) Condition A is that the prescription is signed in ink by the appropriate practitioner giving it.

(3) Condition B is that the prescription—

(a)is written in ink or otherwise so as to be indelible; or

(b)in the case of a health prescription which is not for a [F958product subject to special medical prescription], is written as described in sub-paragraph (a) or by means of carbon paper or similar material.

(4) Condition C is that the prescription contains the following particulars—

(a)the address of the appropriate practitioner giving it;

(b)the appropriate date;

(c)an indication of the kind of appropriate practitioner giving it;

(d)the name and address of the person for whose treatment it is given; and

(e)if that person is under 12, that person's age.

(5) Condition D is that the prescription—

(a)is not dispensed after the end of the period of six months beginning with the appropriate date; or

(b)in the case of a repeatable prescription—

(i)it is not dispensed for the first time after the end of that period, and

(ii)it is dispensed in accordance with the directions contained in the prescription.

(6) Condition E is that, in the case of a repeatable prescription that does not specify the number of times it may be dispensed—

(a)it is not dispensed on more than two occasions, or

(b)in the case of a prescription for an oral contraceptive, it is not dispensed on more than six occasions or after the end of the period of six months beginning with the appropriate date.

(7) In this regulation “appropriate date” means, subject to paragraph (8)—

(a)in the case of a health prescription, whichever is the later of—

(i)the date on which it was signed by the appropriate practitioner giving it, or

(ii)a date indicated by the appropriate practitioner as the date before which it should not be dispensed; and

(b)otherwise, the date on which the prescription was signed by the appropriate practitioner giving it.

(8) This regulation—

(a)does not apply to a prescription given by an [F959approved country health professional] (as to which see regulation 218); and

(b)is subject to regulation 219 (electronic prescriptions).

Textual Amendments

F958Words in reg. 217(3)(b) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(b) and words in reg. 217(3)(b) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(b)

[F960Requirements for prescriptions to be dispensed in an EEA state F961...U.K.

217A.—(1) In this regulation—

“B” means a person who is an appropriate practitioner for the purposes of regulation 214(3) to (5B);

“P” means a person who is the patient of B.

(2) The information specified in paragraph (3) is to be included in any prescription where—

(a)P requests a prescription that is to be dispensed in an EEA state F962...; and

(b)B determines that such a prescription is appropriate.

(3) The specified information is—

(a)the patient’s—

(i)surname,

(ii)first names written out in full, and

(iii)date of birth;

(b)the issue date of the prescription;

(c)B’s—

(i)surname,

(ii)first names written out in full,

(iii)professional qualification,

(iv)direct contact details including—

(aa)email address,

(bb)telephone or fax number with the appropriate international prefix,

(v)work address,

(vi)confirmation that B works as a health professional in the UK, and

(vii)electronic signature or a signature written in ink;

(d)details about the prescribed product, including where applicable the—

(i)common name of the product as defined by Article 1 of the 2001 Directive,

(ii)brand name if—

(aa)the prescribed product is a biological medicinal product, or

(bb)B deems it medically necessary for that product to be dispensed and B’s reasons justifying the use of the branded product,

(iii)pharmaceutical formulation (tablet, solution, etc.),

(iv)quantity,

(v)strength of the medicinal product as defined in Article 1 of the 2001 Directive, and

(vi)dosage regimen.

(4) A prescription under this regulation may only be issued by B in relation to those products that B is authorised to prescribe under regulation 214(3) to (5B).]

Textual Amendments

[F963Original pack dispensing E+W+S

217B.—(1) Subject to paragraphs (2) to (4) and regulation 217C, for the purposes of this Part, the sale or supply of a prescription only medicine is in accordance with a prescription (and with the directions contained in the prescription) where—

(a)a different quantity is sold or supplied to that ordered on the prescription in order to allow for the sale or supply of the medicine in its manufacturer’s original outer packaging; and

(b)the sale or supply is otherwise in accordance with the prescription.

(2) Paragraph (1) does not apply—

(a)to the sale or supply of a different quantity to that ordered on the prescription in circumstances where the different quantity is more than 10% greater or more than 10% less than the quantity ordered on the prescription; or

[F964(b)in circumstances where—

(i)a pharmacist is carrying out, supervising or authorising (under regulation 220B) the carrying out of the sale or supply and the pharmacist considers, or

(ii)in Great Britian, a registered pharmacy technician is carrying out or supervising the sale or supply, pursuant to an authorisation (under regulation 220A) given by a pharmacist, and the registered pharmacy technician considers,

in the exercise of their professional skill and judgement, that the sale or supply of a different quantity to that ordered on the prescription may mean that the patient does not, or is not able to, follow the medication regimen intended by the prescriber.]

(3)  Paragraph (2) does not apply to—

(a)a medicine in a form that makes it not practicable to dispense in the exact quantity ordered;

(b)a medicine in a container that has an integral means of application or from which it is not practicable to dispense an exact quantity;

(c)a medicine that cannot be dispensed in the quantity ordered without adversely affecting the medicine.

(4) Paragraphs (1) to (3) do not apply in relation to a supply of a prescription only medicine that is subject to—

(a)in England, paragraph 8(1)(b) of Schedule 4, or paragraph 6(1)(b) of Schedule 7, to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013,

(b)in Wales, paragraph 9(1)(b) of Schedule 5 to the National Health Service (Pharmaceutical Services) (Wales) Regulations 2020,

until those Regulations expressly apply paragraphs (1) to (3) to those supplies.

Textual Amendments

[F965Original pack dispensing: Northern IrelandNI

217BA.—(1) Subject to paragraphs (2) to (4) and regulation 217CA, for the purposes of this Part, the sale or supply of a prescription only medicine is in accordance with a prescription (and with the directions contained in the prescription) where—

(a)a different quantity is sold or supplied to that ordered on the prescription in order to allow for the sale or supply of the medicine in its manufacturer’s original outer packaging; and

(b)the sale or supply is otherwise in accordance with the prescription.

(2) Paragraph (1) does not apply—

(a)to the sale or supply of a different quantity to that ordered on the prescription in circumstances where the different quantity is more than 10% greater or more than 10% less than the quantity ordered on the prescription; or

(b)in circumstances where a pharmacist is carrying out [F966, supervising or authorising (under regulation 220B) the carrying out of] the sale or supply and the pharmacist considers, in the exercise of their professional skill and judgement, that the sale or supply of a different quantity to that ordered on the prescription may mean that the patient does not, or is not able to, follow the medication regimen as intended by the prescriber.

(3) Paragraph (2) does not apply to—

(a)a medicine in a form that makes it not practicable to dispense in the exact quantity ordered;

(b)a medicine in a container that has an integral means of application or from which it is not practicable to dispense an exact quantity;

(c)a medicine that cannot be dispensed in the quantity ordered without adversely affecting the medicine.

(4) Paragraphs (1) to (3) do not apply in relation to a supply of a prescription only medicine that is subject to paragraphs 2(1) and (1A) of Schedule 2 to the Pharmaceutical Services Regulations (Northern Ireland) 1997,

until those Regulations expressly apply paragraphs (1) to (3) to those supplies.]

Textual Amendments

Original pack dispensing: medicinal products containing a relevant substance E+W+S

217C.—(1) Subject to paragraph (2) and for the purposes of this Part, the sale or supply of a prescription only medicine containing a relevant substance is not in accordance with a prescription unless—

(a)it is sold or supplied in its manufacturer’s original outer packaging; and

(b)if the sale or supply is of a quantity that is different to the quantity which has been ordered on the prescription, it is sold or supplied in a quantity which is as close as possible to the quantity in which it has been ordered on the prescription.

(2) Paragraph (1) does not apply where—

[F967(a)the sale or supply is—

(i)by or under the supervision of or pursuant to an authorisation (under regulation 220B) given by a pharmacist, or

(ii)in Great Britain, by or under the supervision of a registered pharmacy technician, pursuant to an authorisation (under regulation 220A) given by a pharmacist; and]

(b)the pharmacist [F968(in a case to which paragraph (a)(i) applies) or registered pharmacy technician (in a case to which paragraph (a)(ii) applies)] is satisfied that—

(i)a risk assessment is in place that refers to the need for the patient to be sold or supplied the medicine containing a relevant substance in different packaging from its manufacturer’s original outer packaging (for example in a monitored dosage system); and

(ii)unless the medicine containing a relevant substance is unauthorised (other than by reason of it being an authorised product that has ceased to be so as a result of a process of assembly), processes are in place to ensure the supply to or for the patient of the package leaflet.

(3) In this regulation, “relevant substance” means any of the following—

(a)sodium valproate;

(b)valproic acid;

(c)valproate semisodium.]

Textual Amendments

[F969Original pack dispensing: medicinal products containing a relevant substance: Northern IrelandNI

217CA.—(1) Subject to paragraph (2) and for the purposes of this Part, the sale or supply of a prescription only medicine containing a relevant substance is not in accordance with a prescription unless—

(a)it is sold or supplied in its manufacturer’s original outer packaging; and

(b)if the sale or supply is of a quantity that is different to the quantity which has been ordered on the prescription, it is sold or supplied in a quantity which is as close as possible to the quantity in which it has been ordered on the prescription.

(2) Paragraph (1) does not apply where—

(a)the sale or supply is by or under the supervision of [F970or pursuant to an authorisation (under regulation 220B) given by] a pharmacist; and

(b)the pharmacist is satisfied that—

(i)a risk assessment is in place that refers to the need for the patient to be sold or supplied the medicine containing a relevant substance in different packaging from its manufacturer’s original outer packaging (for example in a monitored dosage system); and

(ii)unless the medicine containing a relevant substance is unauthorised (other than by reason of it being an authorised product that has ceased to be so as a result of a process of assembly), processes are in place to ensure the supply to or for the patient of the package leaflet.

(3) In this regulation, “relevant substance” means any of the following—

(a)sodium valproate;

(b)valproic acid;

(c)valproate semisodium.]

Textual Amendments

Requirements for prescriptions: [F971approved country health professional] U.K.

218.—(1) For the purposes of this Chapter, a prescription only medicine is not sold or supplied in accordance with a prescription given by an appropriate practitioner who is an [F972approved country health professional] unless the following conditions are met.

[F973(2) Condition A is that—

(a)the prescription is issued in a [F974country included in the list published under regulation 214(6A)]; and

(b)the prescribing [F972approved country health professional] is legally entitled to issue a prescription of that kind in the country in which the prescription is issued.]

[F975(3) Condition B is that the prescription is signed in ink by the prescribing [F972approved country health professional].]

(4) Condition C is that the prescription is written in ink or otherwise so as to be indelible.

[F976(5) Condition D is that the prescription contains—

(a)the patient’s—

(i)surname,

(ii)first names written out in full, and

(iii)date of birth;

(b)the issue date of the prescription;

(c)the prescribing [F977approved country health professional's]—

(i)surname,

(ii)first names written out in full,

(iii)professional qualification,

(iv)direct contact details including—

(aa)email address, and

(bb)telephone or fax number with the appropriate international prefix,

(v)work address, and

(vi)name of the relevant member State in which that [F972approved country health professional] works; and

(d)details about the prescribed product, including where applicable the—

(i)common name of the product,

(ii)brand name if—

(aa)the prescribed product is a biological medicinal product, or

(bb)the prescribing [F972approved country health professional] deems it medically necessary for that product to be dispensed and the [F978approved country health professional's] reasons justifying the use of the branded product,

(iii)pharmaceutical formulation (tablet, solution, etc.),

(iv)quantity,

(v)strength of the medicinal product as defined in Article 1 of the 2001 Directive, and

(vi)dosage regimen.]

(6) Condition E is that the prescription—

(a)is not dispensed after the end of the period of six months beginning with the date on which it is signed by the [F972approved country health professional]; or

(b)in the case of a repeatable prescription—

(i)it is not dispensed for the first time after the end of that period, and

(ii)it is dispensed in accordance with the directions contained in the prescription.

(7) Condition F is that, in the case of a repeatable prescription that does not specify the number of times it may be dispensed—

(a)it is not dispensed on more than two occasions; or

(b)in the case of a prescription for an oral contraceptive, it is not dispensed on more than six occasions or after the end of the period of six months beginning with the date on which it is signed by the [F972approved country health professional].

(8) This regulation is subject to regulation [F979219A (electronic prescriptions: EEA health professionals)].

Textual Amendments

F975Reg. 218(3) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 7(3) and reg. 218(3) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 7(3)

F976Reg. 218(5) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 7(4) and reg. 218(5) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 7(4)

F979Words in reg. 218(8) substituted (E.W.S.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 3 and words in reg. 218(8) substituted (N.I.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 3

Electronic prescriptionsU.K.

219.—(1) This regulation applies to a prescription that is not a health prescription for a [F980substance or product for the time being specified in Schedule 1 to the Misuse of Drugs Regulations 2001 or in Schedule 1 to the Misuse of Drugs Regulations (Northern Ireland) 2002].

(2) A prescription only medicine is also sold or supplied in accordance with a prescription given by an appropriate practitioner other than an [F981approved country health professional] if—

(a)conditions A and B in regulation 217 are not met; but

(b)the conditions in paragraph (4) of this regulation and conditions C to E in regulation 217 are met.

F982(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) The conditions mentioned in [F983paragraph (2)(b)] are that the prescription is—

(a)created in electronic form;

[F984(b)signed with an advanced electronic signature; and

(c)sent to the person by whom it is dispensed—

(i)as an electronic communication (whether or not through one or more intermediaries), and

(ii)via the electronic prescription service, if it is for a substance or product for the time being specified in Schedule 2 or 3 to the Misuse of Drugs Regulations 2001 or in Schedule 2 or 3 to the Misuse of Drugs Regulations (Northern Ireland) 2002.]

[F985(5) In this regulation—

[F986“advanced electronic signature” has the meaning given within Article 3(11) of Regulation (EU) No 910/2014 of the European Parliament and of the Council on electronic identification and trust services for electronic transactions in the internal market;]

“electronic prescription service” means the service of that name which is managed by [F987NHS England, the body corporate established under section 1H of the National Health Service Act 2006.]]

Textual Amendments

F980Words in reg. 219(1) substituted (E.W.S.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 4(2) and words in reg. 219(1) substituted (N.I.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 4(2)

F982Reg. 219(3) omitted (E.W.S.) (1.7.2015) by virtue of The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 4(3) and reg. 219(3) omitted (N.I.) (1.7.2015) by virtue of The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 4(3)

F983Words in reg. 219(4) substituted (E.W.S.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 4(4)(a) and words in reg. 219(4) substituted (N.I.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 4(4)(a)

[F988Electronic Prescriptions: [F989approved country health professionals]U.K.

219A.—(1) This regulation applies to a prescription that is not a health prescription for a product subject to special medical prescription.

(2) A prescription only medicine is also sold or supplied in accordance with a prescription given by an [F990approved country health professional] if—

(a)conditions B and C in regulation 218 are not met; but

(b)the conditions in paragraph (3) of this regulation and conditions A and D to F in regulation 218 are met.

(3) The conditions mentioned in paragraph (2)(b) are that the prescription is—

(a)created in electronic form;

(b)signed with an electronic signature; and

(c)sent to the person by whom it is dispensed as an electronic communication (whether or not through one or more intermediaries).]

Textual Amendments

Medicines not subject to general saleU.K.

Sale or supply of medicinal products not subject to general saleU.K.

220.—(1) Unless paragraph (2) applies, a person (“P”) may not sell or supply, or offer for sale or supply, a medicinal product that is not subject to general sale.

(2) This paragraph applies if—

(a)P is a person lawfully conducting a retail pharmacy business;

(b)the product is sold, supplied, or offered for sale or supply, [F991at or from premises] that are a registered pharmacy; and

[F992(c)P or, if the transaction is carried out on P’s behalf by another person, that other person—

(i)is, or acts under the supervision of, a pharmacist, or

(ii)acts in accordance with regulation 220A or 220B.]

(3) This regulation is subject to Chapter 3.

Textual Amendments

General sale medicinesU.K.

[F993Sale or supply of items dispensed by a pharmacist who is absent or treated as absentU.K.

220B.—(1) A person (P1) acts in accordance with this regulation where—

(a)the transaction relates to a medicinal product that has been dispensed by or under the supervision of a pharmacist (P2) and is ready for sale or supply to or for the person for whom it has been dispensed;

(b)P2 authorises P1 to carry out the transaction in question on P2’s behalf in P2’s absence; and

(c)P1 carries out that transaction on P2’s behalf—

(i)in P2’s absence, or

(ii)in circumstances where P2 is treated as being absent,

in accordance with any conditions or restrictions that P2 has imposed pursuant to paragraph (2), sub-paragraphs (b) or (c) (and the authorisation has not been withdrawn).

(2) An authorisation given for the purposes of paragraph (1)(b)—

(a)may be given orally or in writing;

(b)may be given subject to conditions or restrictions; and

(c)may be varied or withdrawn by P2.

(3) In giving an authorisation for the purposes of paragraph (1)(b), P2 must have due regard to patient safety.

(4) A failure to comply with paragraph (3)—

(a)does not affect the validity of any authorisation, but

(b)may constitute misconduct for the purposes of section 80 of the Medicines Act 1968 (power for relevant disciplinary committee to disqualify and direct removal from register) or article 51(1)(a) of the Pharmacy Order 2010 (impairment of fitness to practise) and the relevant disciplinary committee may deal with any such failure accordingly.

(5) For the purposes of paragraph (1)(c)(ii), P2 is to be treated as being absent from premises that are a registered pharmacy if P2 is at the pharmacy but not available to intervene in, or not in a position to intervene in, the transaction in question.]

Textual Amendments

Sale or supply of medicinal products subject to general saleU.K.

221.—(1) A person (“P”) may not sell or supply, or offer for sale or supply, a medicinal product that is subject to general sale elsewhere than at [F994or from] a registered pharmacy unless the following conditions are met.

(2) Condition A is that the place at [F995or from] which the medicinal product is sold, supplied, or offered for sale or supply, consists of premises of which P is the occupier and which P is able to close so as to exclude the public.

(3) Condition B is that—

(a)the medicinal product was made up for sale in its immediate and outer packaging elsewhere than at the place at [F996or from] which it is sold, supplied, or offered for sale or supply; and

(b)the immediate and outer packaging has not been opened since the product was made up for sale in it.

(4) Condition C is that, if the medicinal product is of a kind specified in Schedule 15, it is presented for sale in accordance with the requirements specified in that Schedule for a product of that kind.

(5) This regulation is subject to Chapter 3.

Textual Amendments

Sale of medicinal products from automatic machinesU.K.

222.  A person may not sell or offer for sale a medicinal product by means of an automatic machine if the product is not subject to general sale.

[F997Assembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businessesU.K.

222A.—(1) Paragraph (2) applies where—

(a)an order for the sale or supply of a medicinal product to or for the use of a particular patient (P) is submitted to a person acting in the course of a retail pharmacy business or an NHS dispensing practice;

(b)the person carrying on the retail pharmacy business or the NHS dispensing practice (B1) has entered into written arrangements (whether or not legally binding) with a person carrying on a retail pharmacy business (B2) which—

(i)are for the purpose of B2 supporting B1 with regard to the fulfilment of orders submitted as mentioned in sub-paragraph (a) (but must not allow B2 to fulfil the order directly), and

(ii)include (but are not limited to) a comprehensive statement of the responsibilities of B1 and B2 in relation to those orders;

(c)B1 has conspicuously displayed a notice—

(i)at B1’s registered pharmacy or premises of B1’s NHS dispensing practice, if B1 supplies medicinal products to patients who are present at that pharmacy or those premises, and

(ii)in B1’s dispensing content for patients, if B1 sells or supplies medicinal products by means of an internet service,

containing the names and addresses of any parties with whom they have entered into arrangements of the type mentioned in sub-paragraph (b) and a brief statement of the general effect of the arrangements;

(d)the medicinal product is—

(i)assembled or part-assembled in the course of B2’s business, and

(ii)sold or supplied by B2 to B1,

as part of the written arrangements of the type mentioned in sub-paragraph (b); and

(e)the activities carried out as mentioned in sub-paragraph (d) are carried out with a view to any of the following taking place at or from premises of B1 (following further assembly in the case of part-assembled products)—

(i)the retail sale of the product by B1 to or for the use of P, or

(ii)the supply of the product in circumstances corresponding to retail sale by B1 to or for the use of P.

(2) For the purposes of these Regulations and the Medicines Act 1968, each sale or supply mentioned in paragraph (1)(d)(ii) by B2—

(a)is treated as or as part of a retail sale; and

(b)is treated as being in accordance with a prescription if—

(i)it is for the purpose of fulfilling an order that is a prescription, and

(ii)the final sale or supply is in accordance with the prescription,

notwithstanding that B2 does not have the prescription.

(3) The definitions of “sell” and “supply” in regulation 213(1) do not apply for the purposes of this regulation.

(4) Where both B1 and B2 are retail pharmacy businesses and a pharmacist may, pursuant to regulation 217B, 217BA or 226A, change an order for the sale or supply of a medicinal product, the final decision as regards whether or not that change is to be made for the sale or supply to or for the use of P is for a pharmacist acting on behalf of B1, even if—

(a)an initial decision, in accordance with which a retail sale was made by B2 to B1, was made by a pharmacist acting on behalf of B2; and

(b)the final decision by the pharmacist acting on behalf of B1 is by way of a confirmation of what the pharmacist acting on behalf of B2 initially decided.]

Textual Amendments

[F997Hub and spoke arrangements: sharing of data between different businessesU.K.

222B.—(1) For the purposes of section 8(c) (lawfulness of processing: public interest etc) of, and paragraph 2(2)(a), (c) and (d) of Schedule 1 (special categories of personal data etc) to, the Data Protection Act 2018, paragraph (2) applies to the processing of any data—

(a)by B1 or B2 (as defined in regulation 222A(1)(b)) which relates to a patient; and

(b)which is necessary for the purposes of—

(i)fulfilling an order submitted as mentioned in regulation 222A(1)(a) under the written arrangements between B1 and B2 of the type mentioned in regulation 222A(1)(b), or

(ii)discharging any related professional obligations to the patient (including obligations relating to the keeping of records).

(2) That processing is—

(a)necessary for the performance of a task carried out in the public interest; and

(b)if the data is personal data concerning health, necessary for the purposes of preventative medicine, medical diagnosis or for the provision of health care or treatment.

(3) Any person (P) who—

(a)is employed or engaged by B1 or B2; and

(b)in the course of being so employed or engaged is required to undertake the processing of data described in paragraph (1),

owes a duty of confidentiality in respect of that data (whether or not they would do so but for this paragraph).

(4) That duty—

(a)is a duty of confidentiality which, if not owed by a health care professional, is owed under an enactment or rule of law for the purposes of section 11(1)(b) of the Data Protection Act 2018 (special categories of personal data etc: supplementary); and

(b)is such that, if the processing is necessary for the purposes described in paragraph (1)(b), P is able, lawfully, to process that data by virtue of this regulation.

(5) For the purposes of paragraph (1)(b)(ii), a professional obligation to a patient is to be regarded as such notwithstanding that discharging the obligation may—

(a)also be an obligation that arises in some other way (for example, arising from a term of service that is part of NHS pharmaceutical services); or

(b)be done by a person who is not a health care professional.

(6) Paragraphs (1) and (2) do not apply where, in reliance or purported reliance on arrangements of the type mentioned in regulation 222A(1)(b), a person processes any data which relates to a patient but, in the course of the doing of anything that relates to the fulfilling of the order to which that data relates, there is a breach of—

(a)the requirements to be fulfilled if what is done is to be treated as or as part of a retail sale in accordance with regulation 222A(2)(a); or

(b)a duty of confidentiality owed in respect of the data by a health care professional or under an enactment or rule of law as mentioned in paragraph (4)(a).

(7) Words and expressions used in both—

(a)paragraphs (1) to (6); and

(b)Parts 1 and 2 (preliminary and general processing) of, and paragraphs 2(2)(a), (c) and (d) of Schedule 1 to, the Data Protection Act 2018,

bear the meanings they bear in those provisions of the Data Protection Act 2018.]

Textual Amendments

CHAPTER 3U.K.Exemptions

Exemptions relating to supply in specific circumstancesU.K.

Exemptions for doctors and dentists etcU.K.

223.—(1) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a doctor or dentist to a patient of that doctor or dentist.

(2) Regulations 220 and 221 do not apply to the sale, offer for sale, or supply of a medicinal product by a doctor or dentist—

(a)to a patient of the doctor or dentist, or

(b)to a person under whose care such a patient is.

(3) Regulations 220 and 221 do not apply to the sale, offer for sale or supply of a medicinal product in the course of the business of a hospital or health centre, where—

(a)the product is sold, offered for sale or supplied for the purposes of being administered to a person (whether in the hospital or health centre or elsewhere) in accordance with directions relating to that person; and

(b)those directions have been given by—

(i)a doctor,

(ii)a dentist,

(iii)a supplementary prescriber,

(iv)a pharmacist independent prescriber,

(v)an optometrist independent prescriber,

[F998(vi)a nurse independent prescriber,

(vii)a community practitioner nurse prescriber,

(viii)a podiatrist independent prescriber, F999...

(ix)a physiotherapist independent prescriber]F1000...

[F1001(x)a therapeutic radiographer independent prescriber][F1002, or

(xi)a paramedic independent prescriber.]

(4) Regulations 220 and 221 do not apply to the sale or supply of a medicinal product to which paragraph (5) applies where—

(a)the product is sold or supplied by a registered midwife in the course of the registered midwife's professional practice; or

(b)the product is delivered or administered by a registered midwife on being supplied the product under arrangements made by the Secretary of State or the Minister for Health, Social Services and Public Safety.

(5) The products to which this paragraph applies are—

(a)medicinal products that are not prescription only medicines;

(b)prescription only medicines which by virtue of an exemption conferred under regulation 235(1) and 235(3) and Part 1 of Schedule 17 may be sold or supplied by a registered midwife otherwise than in accordance with a prescription given by a doctor or a dentist; and

(c)prescription only medicines which by virtue of an exemption conferred under regulation 235(3) and Part 3 of Schedule 17 may be administered by a registered midwife or a student midwife otherwise than in accordance with a prescription given by a doctor or a dentist.

Textual Amendments

F998Reg. 223(3)(b)(vi)-(ix) substituted for reg. 223(3)(b)(vi)(vii) (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 27

F999Word in reg. 223(3)(b)(viii) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 10(2)(a) and word in reg. 223(3)(b)(viii) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 10(2)(a)

F1000Word in reg. 223(3)(b)(ix) omitted (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 7(2)(a) and word in reg. 223(3)(b)(ix) omitted (N.I.) (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 7(2)(a)

F1001Reg. 223(3)(b)(x) and preceding word inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 10(2)(b) and reg. 223(3)(b)(x) and preceding word inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 10(2)(b)

F1002Reg. 223(3)(b)(xi) and preceding word inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 7(2)(b) and reg. 223(3)(b)(xi) and preceding word inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 7(2)(b)

Emergency sale etc by pharmacist: prescriber unable to provide prescriptionU.K.

224.—(1) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business if conditions A to E are met.

(2) Condition A is that the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied is satisfied that the sale or supply has been requested by a relevant prescriber who by reason of an emergency is unable to provide a prescription immediately.

(3) Condition B is that the relevant prescriber has undertaken to provide the person lawfully conducting the retail pharmacy business with a prescription within the period of 72 hours beginning with the sale or supply.

(4) Condition C is that the prescription only medicine is sold or supplied in accordance with the directions of the relevant prescriber.

(5) Condition D is that the prescription only medicine is not a [F1003product subject to special medical prescription], other than a prescription only medicine that—

(a)consists of or contains phenobarbital or phenobarbital sodium; and

(b)is sold or supplied for use in the treatment of epilepsy.

(6) Condition E is that an entry is made in the record kept under regulation 253 within the time specified in that regulation stating the particulars required under paragraph 2 of Schedule 23.

Textual Amendments

F1003Words in reg. 224(5) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(d) and words in reg. 224(5) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(d)

Emergency sale etc by pharmacist: at patient's requestU.K.

225.—(1) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business if conditions A to E are met.

(2) Condition A is that the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied has interviewed the person requesting it and is satisfied—

(a)that there is an immediate need for the prescription only medicine to be sold or supplied and that it is impracticable in the circumstances to obtain a prescription without undue delay;

(b)that treatment with the prescription only medicine has on a previous occasion been prescribed by a relevant prescriber for the person requesting it; and

(c)as to the dose which in the circumstances it would be appropriate for that person to take.

(3) Condition B is that for a prescription only medicine shown in column 1 of the following table, the quantity of the product that is sold or supplied does not exceed that shown in column 2 for that prescription only medicine—

Prescription only medicineMaximum quantity

A prescription only medicine that—

(a)is a preparation of insulin, an aerosol for the relief of asthma, an ointment or cream, and

(b)has been made up for sale in a package elsewhere than at the place of sale or supply.

The smallest pack that the pharmacist has available for sale or supply.

An oral contraceptive.A quantity sufficient for a full treatment cycle.
An antibiotic for oral administration in liquid form.The smallest quantity that will provide a full course of treatment.
A controlled drug within the meaning of Schedule 4 or 5 of the Misuse of Drugs Regulations 2001 or Schedule 4 or 5 of the Misuse of Drugs Regulations (Northern Ireland) 2002.Five days' treatment.
Any other prescription only medicine.30 days' treatment.

(4) Condition C is that the prescription only medicine—

(a)does not consist of or contain a substance specified in Schedule 18; and

(b)is not a [F1004product subject to special medical prescription], other than a prescription only medicine that—

(i)consists of or contains phenobarbital or phenobarbital sodium, and

(ii)is sold or supplied for use in the treatment of epilepsy.

(5) Condition D is that an entry is made in the record kept under regulation 253 within the time specified in that regulation stating the particulars required under paragraph 4 of Schedule 23.

(6) Condition E is that the inner or outer packaging of the prescription only medicine is labelled to show—

(a)the date on which the prescription only medicine is sold or supplied;

(b)the name, quantity and (unless apparent from the name) the pharmaceutical strength of the prescription only medicine;

(c)the name of the person requesting the prescription only medicine;

(d)the name and address of the registered pharmacy from which the prescription only medicine is sold or supplied; and

(e)the words “Emergency Supply”.

(7) In this regulation “aerosol” means a product that is dispersed from its container by a propellant gas or liquid.

Textual Amendments

F1004Words in reg. 225(4)(b) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(e) and words in reg. 225(4)(b) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(e)

Emergency sale etc by pharmacist: pandemic diseasesU.K.

226.—(1) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business if conditions A and B are met.

(2) Condition A is that the supply is made whilst a disease is, or in anticipation of a disease being imminently,—

(a)pandemic; and

(b)a serious risk, or potentially a serious risk, to human health.

(3) Condition B is that the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied is satisfied—

(a)that treatment with the prescription only medicine has on a previous occasion been prescribed by a relevant prescriber for the person to be treated with it; and

(b)as to the dose which in the circumstances it would be appropriate for that person to take.

[F1005Sale etc by a pharmacist in accordance with a serious shortage protocolU.K.

226A.—(1) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business if conditions A, B and C are met.

(2) Condition A is that the prescription only medicine is sold or supplied for the purpose of being administered to a person in accordance with a serious shortage protocol (SSP).

(3) Condition B is that the requirements of the SSP are satisfied in respect of to whom, and subject to what conditions, the prescription only medicine may be sold or supplied for the purpose of being administered.

(4) Condition C is that the sale or supply of the prescription only medicine is by or under the supervision of a pharmacist who is of the opinion, in the exercise of his or her professional skill and judgement, that—

(a)in a case to which paragraph (5)(b)(i) applies, the sale or supply of a different strength, quantity or pharmaceutical form of the prescription only medicine to the strength, quantity or pharmaceutical form of the prescription only medicine ordered by the prescriber is reasonable and appropriate; or

(b)in a case to which paragraph (5)(b)(ii) applies, the sale or supply of—

(i)a prescription only medicine other than the prescription only medicine ordered by the prescriber is reasonable, and

(ii)the substituted prescription only medicine, in accordance with the directions for use that he or she specifies, is appropriate.

(5) For the purposes of this regulation, a SSP is a written protocol that—

(a)is issued by the Ministers (either of them acting alone or both of them acting jointly) in circumstances where the United Kingdom or any part of the United Kingdom is, in the opinion of the Ministers (either of them forming the opinion alone or both of them forming the opinion jointly), experiencing or may experience a serious shortage of a prescription only medicine or prescription only medicines of a specified description;

(b)provides for the sale or supply by or under the supervision of a pharmacist and subject to such conditions as may be specified in the SSP—

(i)of a different strength, quantity or pharmaceutical form of the prescription only medicine to the strength, quantity or pharmaceutical form ordered by the prescriber, or

(ii)of a prescription only medicine other than the prescription only medicine ordered by the prescriber;

(c)provides, in a case to which sub-paragraph (b)(ii) applies, that the other prescription only medicine is to be—

(i)a generic version of the prescription only medicine being substituted, or that both products are generic versions of another prescription only medicine,

(ii)in the case of a biological medicinal product, a similar medicinal product to the prescription only medicine being substituted, or that both products are similar medicinal products to another biological medicinal product, or

(iii)a prescription only medicine that has a similar therapeutic effect to the prescription only medicine being substituted; and

(d)specifies the period for which, and the parts of the United Kingdom (which may be all of the United Kingdom) in which, the protocol is to have effect.

(6) As soon as is reasonably practical after the end of one year beginning on the day on which the first protocol issued under this regulation has effect, the Ministers must—

(a)review the operation of this regulation with a view to evaluating whether there have been any adverse consequences for the market in prescription only medicines or for patient safety as a consequence of the operation of this regulation;

(b)set out the conclusions of the review in a report; and

(c)publish the report.]

Textual Amendments

Exemption for sale or supply in hospitalsU.K.

227.—(1) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine—

(a)in the course of the business of a hospital; and

(b)for the purpose of being administered (in the hospital or elsewhere) to a particular person in accordance with directions that meet the conditions in paragraph (2).

(2) Those conditions are that the directions—

(a)are in writing;

(b)relate to the particular person to whom the prescription only medicine is to be administered; and

(c)are given by a person who is an appropriate practitioner in relation to that prescription only medicine.

(3) But such directions may be given by a supplementary prescriber only where the supplementary prescriber complies with regulations 215 (prescribing and administration by supplementary prescribers) and 216 (exceptions to regulation 215) in relation to the directions as if they were a prescription.

(4) This regulation applies regardless of whether the directions comply with regulation 217 (requirements for prescriptions).

Exemptions relating to prescriptions given by certain health professionalsU.K.

228.—(1) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a pharmacist where—

(a)the sale or supply is in accordance with a prescription given by a person listed in paragraph (2) who is not an appropriate practitioner in relation to that prescription only medicine; but

(b)the pharmacist, having exercised all due diligence, believes on reasonable grounds that the person is such a practitioner.

(2) Those persons are—

(a)another pharmacist;

(b)a registered nurse;

(c)a registered midwife;

(d)a person whose name is entered in the part of the Health and Care Professions Council register relating to—

(i)chiropodists and podiatrists,

(ii)physiotherapists, F1006...

(iii)radiographers: diagnostic or therapeutic; or

[F1007(iv)paramedics; or]

(e)a registered optometrist.

(3) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a pharmacist where—

(a)the sale or supply is in accordance with a prescription given by a supplementary prescriber; and

(b)the pharmacist, having exercised all due diligence, believes on reasonable grounds that the supplementary prescriber has complied with regulation 215.

Textual Amendments

F1006Word in reg. 228(2)(d)(ii) omitted (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 8(2)(a) and word in reg. 228(2)(d)(ii) omitted (N.I.) (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 8(2)(a)

Exemption for supply by national health service bodies [F1008and local authorities] U.K.

229.—(1) Regulations 214(1) [F1009and (2)], 220 and 221 do not apply to the supply of a medicinal product in accordance with condition A or B by—

(a)the Common Services Agency;

(b)a health authority or special health authority;

(c)an NHS trust;

(d)an NHS foundation trust;

[F1010(da)a local authority in the exercise of public health functions (within the meaning of the National Health Service Act 2006); F1011...]

[F1012(db)the United Kingdom Health Security Agency;]

(dc)Public Health Agency; or

F1013(e). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(f)a person who is not a doctor, dentist or person lawfully conducting a retail pharmacy business, where the person supplies the product pursuant to an arrangement with [F1014[F927an integrated care board], [F928NHS England] or] one of the persons specified in paragraphs (a) [F1015to [F1016(dc)]].

(2) Condition A is that the product is supplied for the purpose of being administered to a person in accordance with the written directions of a doctor, dentist, nurse independent prescriber, optometrist independent prescriber [F1017, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber] [F1018, paramedic independent prescriber] or pharmacist independent prescriber relating to that person, regardless of whether the directions comply with regulation 217 (requirements for prescriptions).

[F1019(2A) In relation to a medicinal product that is for parenteral administration, condition A only applies if the person who has given the written directions is an appropriate practitioner in relation to that medicinal product.]

(3) Condition B is that—

(a)the product is supplied for the purpose of being administered to a person in accordance with a patient group direction (“PGD”);

(b)the PGD relates to the supply of a description or class of medicinal product by the person by whom the medicinal product is supplied and has effect at the time at which it is supplied;

(c)the PGD contains the particulars specified in Part 1 of Schedule 16;

(d)the PGD is signed on behalf of the person specified in column 2 of the table in Part 2 of that Schedule (“the authorising person”) against the entry in column 1 of that table for the class of person by whom the product is supplied;

(e)the individual who supplies the product—

(i)belongs to one of the classes of individual specified in Part 4 of that Schedule, and

(ii)is designated in writing, on behalf of the authorising person, for the purpose of the supply or administration of products under the PGD; and

[F1020(f)when the product is supplied [F1021, either an authorisation by the licensing authority on a temporary basis under regulation 174 or]—

(i)in Northern Ireland, a UKMA(NI), UKMA(UK)F1022..., Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), [F1023or, in the case of a listed NIMAR product, a UKMA(UK) or UKMA(GB),] or

(ii)in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),

is in force in relation to it.]

F1024(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1011Word in reg. 229(1)(da) omitted (E.W.S.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 4(2)(a) and word in reg. 229(1)(da) omitted (N.I.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 4(2)(a)

F1016Word in reg. 229(1)(f) substituted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 4(2)(c) and word in reg. 229(1)(f) substituted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 4(2)(c)

F1017Words in reg. 229(2) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 11 and words in reg. 229(2) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 11

F1018Words in reg. 229(2) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 9 and words in reg. 229(2) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 9

Exemption for supply etc under a PGD to assist doctors or dentistsU.K.

230.—(1) Regulations 214, 220 and 221 do not apply to the supply or administration of a medicinal product by an individual belonging to one of the classes specified in Part 4 of Schedule 16 where—

(a)the individual supplies or (as the case may be) administers the product to assist a doctor in the provision of NHS primary medical services or a dentist in the provision of NHS primary dental services;

(b)the product is supplied for the purpose of being administered to a person in accordance with a patient group direction (“PGD”); and

(c)the following conditions are met.

(2) Condition A is that the PGD relates to the supply or (as the case may be) administration of a description or class of medicinal product in order to assist the doctor or dentist in providing the services (whether or not it relates to such supply in order to assist any other doctor or dentist).

(3) Condition B is that the PGD has effect at the time at which the product is supplied or (as the case may be) administered.

(4) Condition C is that the PGD contains the particulars specified in Part 1 of Schedule 16 (but with the omission of paragraph 4 in the case of a PGD relating to administration only).

(5) Condition D is that the PGD is signed—

(a)by the doctor or dentist; or

(b)where it also relates to supply or administration to assist one or more other doctors or dentists, by one of those doctors or dentists.

(6) Condition E is that the PGD is signed—

(a)in the case of—

(i)NHS primary medical services, or

(ii)NHS primary dental services in England or Wales,

on behalf of the health authority[F1025, local authority or National Health Service Commissioning Board] with which a contract or agreement for the provision of those services has been made or which provides those services;

(b)in the case of dental services in Scotland under the National Health Service (Scotland) Act 1978 M57, or general dental services in Northern Ireland, on behalf of the health authority with which an arrangement for the provision of those services has been made; and

(c)in the case of personal dental services provided under a pilot scheme in Scotland or Northern Ireland, on behalf of the health authority which is a party to the pilot scheme.

(7) Condition F is that the individual supplying the product is designated in writing for the purpose of the supply or (as the case may be) administration of medicinal products under the PGD—

(a)by the doctor or dentist; or

(b)where it also relates to supply to assist one or more other doctors or dentists, by one of those doctors or dentists.

[F1026(8) Condition G is that when the product is supplied or (as the case may be) administered [F1027, either an authorisation by the licensing authority on a temporary basis under regulation 174 or]—

(a)in Northern Ireland, a UKMA(NI), UKMA(UK)F1028..., Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), [F1029or, in the case of a listed NIMAR product, a UKMA(UK) or UKMA(GB),] or

(b)in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),

is in force in relation to it.]

Textual Amendments

Marginal Citations

Exemption for supply etc under a PGD by independent hospitals etcU.K.

231.—(1) Regulations 214, 220 and 221 do not apply to the sale or supply, or administration, of a medicinal product in accordance with the following conditions by—

(a)an independent hospital;

(b)an independent clinic;

(c)an independent medical agency; or

(d)a nursing home (in Northern Ireland).

(2) Condition A, which applies only to England, is that the registered provider at the hospital, clinic or agency is registered in compliance with section 10 of the Health and Social Care Act 2008 M58 in respect of one or more of the following regulated activities M59—

(a)treatment of disease, disorder or injury;

(b)assessment or medical treatment of persons detained under the Mental Health Act 1983;

(c)surgical procedures;

(d)diagnostic and screening procedures;

(e)maternity and midwifery services; and

(f)family planning.

(3) Condition B is that the product is sold or supplied for the purpose of being administered to a person in accordance with a patient group direction (“PGD”).

(4) Condition C is that the PGD—

(a)relates to the sale or supply or (as the case may be) administration of a description or class of medicinal product by the person by whom the medicinal product is sold or supplied or administered; and

(b)has effect at the time at which it is sold or supplied.

(5) Condition D is that the PGD contains the particulars specified in Part 1 of Schedule 16 (but with the omission of paragraph 4 in the case of a PGD relating to administration only).

(6) Condition E is that the PGD is signed—

(a)by or on behalf of the registered provider; and

(b)if there is a relevant manager for the independent hospital, clinic or medical agency, or nursing home, by that manager.

(7) Condition F is that the individual who sells or supplies or (as the case may be) administers the product—

(a)belongs to one of the classes of individual specified in Part 4 of Schedule 16; and

(b)is designated in writing for the purpose of the sale or supply or (as the case may be) administration of products under the PGD—

(i)by or on behalf of the registered provider, or

(ii)if there is a relevant manager for the independent hospital, clinic or medical agency, or nursing home, by that manager.

[F1030(8) Condition G is that when the product is supplied [F1031, either an authorisation by the licensing authority on a temporary basis under regulation 174 or]—

(a)in Northern Ireland, a UKMA(NI), UKMA(UK)F1032..., Article 126a authorisation, certificate of registration, THR(NI) or THR(UK) [F1033or, in the case of a listed NIMAR product, a UKMA(UK) or UKMA(GB),] or

(b)in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),

is in force in relation to it.]

Textual Amendments

Marginal Citations

M59Regulated activities for the purposes of section 10 are defined in section 8 of that Act and set out in regulation 3 of, and Schedule 1 to, S.I. 2010/781.

Exemption for supply etc under a PGD by dental practices and clinics: England and WalesU.K.

232.—(1) Regulations 214, 220 and 221 do not apply to the sale or supply, or administration, of a medicinal product in accordance with the following conditions by—

(a)a dental practice in England and Wales to which paragraph (2) applies; or

(b)a dental clinic in England and Wales to which paragraph (2) applies.

(2) This paragraph applies to a dental practice or dental clinic —

(a)in England, in respect of which the registered provider is registered in compliance with section 10 of the Health and Social Care Act 2008 in respect of one or both of the following regulated activities—

(i)treatment of disease, disorder or injury, or

(ii)diagnostic and screening procedures;

(b)in Wales, in which dental services are provided by private dentists and those dentists are registered with Healthcare Inspectorate Wales in accordance with the Private Dentistry (Wales) Regulations 2008 M60, in relation to the services provided by those dentists.

(3) Condition A is that the product is sold or supplied for the purpose of being administered to a person in accordance with a patient group direction (“PGD”).

(4) Condition B is that the PGD—

(a)relates to the sale or supply or (as the case may be) administration of a description or class of medicinal product by the person by whom the medicinal product is sold or supplied or administered; and

(b)has effect at the time at which it is sold or supplied.

(5) Condition C is that the PGD contains the particulars specified in Part 1 of Schedule 16 (but with the omission of paragraph 4 in the case of a PGD relating to administration only).

(6) Condition D is that the PGD is signed—

(a)in England—

(i)by or on behalf of the registered provider, and

(ii)if there is a relevant manager for the practice or clinic, by that manager;

(b)in Wales—

(i)by the private dentist who is treating the person, and

(ii)if there is a manager for the practice or clinic, by that manager.

(7) Condition E is that the individual who sells or supplies or (as the case may be) administers the product—

(a)belongs to one of the classes of individual specified in Part 4 of Schedule 16; and

(b)is designated in writing for the purpose of the sale or supply or (as the case may be) administration of products under the PGD—

(i)in England—

(aa)by or on behalf of the registered provider, or

(bb)if there is a relevant manager for the practice or clinic, by that manager, or

(ii)in Wales, by the private dentist who is treating the person.

[F1034(8) Condition F is that when the product is supplied, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK) is in force in relation to it.]

(9) In relation to Wales, in this regulation “manager” means—

(a)a person who carries on the dental practice or dental clinic; or

(b)if there is no such person, a person who manages the practice or clinic.

Textual Amendments

Marginal Citations

Exemption for supply etc under a PGD by person conducting a retail pharmacy businessU.K.

233.—(1) Regulation 214 does not apply to the sale or supply, or administration, of a prescription only medicine by a person lawfully conducting a retail pharmacy business where—

(a)the person sells, supplies or (as the case may be) administers the prescription only medicine pursuant to an arrangement for the supply or administration of prescription only medicines with—

(i)the Common Services Agency,

(ii)a health authority or special health authority,

(iii)an NHS trust,

(iv)an NHS foundation trust,

[F1035(iva)[F927an integrated care board],

(ivb)[F928NHS England],

(ivc)a local authority in the exercise of public health functions (within the meaning of the National Health Service Act 2006),]

[F1036(ivd)the United Kingdom Health Security Agency,]

(ive)Public Health Agency,

F1037(v). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(vi)a police force in England, Wales or Scotland,

(vii)the Police Service of Northern Ireland,

(viii)a prison service,

(ix)Her Majesty's Forces, or

(x)an authority or person carrying on the business of an independent hospital, an independent clinic, an independent medical agency or, in Northern Ireland, a nursing home;

(b)the prescription only medicine is sold or supplied for the purpose of being supplied or (as the case may be) is administered to a person in accordance with a patient group direction (“PGD”); and

(c)the following conditions are met.

(2) Condition A is that the PGD relates to the sale or supply or (as the case may be) administration of a description or class of medicinal product by the person lawfully conducting a retail pharmacy business who sells or supplies or (as the case may be) administers the prescription only medicine.

(3) Condition B is that the PGD has effect at the time at which the prescription only medicine is sold or supplied or (as the case may be) administered.

(4) Condition C is that the PGD contains the particulars specified in Part 1 of Schedule 16 (but with the omission of paragraph 4 in the case of a PGD relating to administration only).

(5) Condition D is that the PGD is signed—

(a)in the case of an arrangement with a body referred to in paragraph (1)(a)(i) [F1038to (ive) (health bodies), by or on behalf of the person specified in column 2 of Part 2 of Schedule 16 against the entry in column 1 for that body];

(b)in the case of an arrangement with a police force in England, Wales or Scotland or with the Police Service of Northern Ireland—

(i)by or on behalf of a person specified in column 2 of Part 3 of Schedule 16 against the entry in column 1 for that body, and

(ii)by a doctor who is not employed or engaged by, and does not provide services under arrangements made with, any police force or the Police Service of Northern Ireland;

(c)in the case of an arrangement with a prison service, by or on behalf of a person specified in column 2 of Part 3 of Schedule 16 against the entry in column 1 for that body;

(d)in the case of an arrangement with Her Majesty's Forces, by or on behalf of a person specified in column 2 of Part 3 of Schedule 16 against the entry in column 1 for Her Majesty's Forces;

(e)in the case of an arrangement with an authority or person referred to in paragraph (1)(a)(x) (independent hospitals etc)—

(i)by or on behalf of the registered provider, and

(ii)if there is a relevant manager for the establishment or agency in question, by that manager.

(6) Condition E is that, where the prescription only medicine is administered by the person lawfully conducting a retail pharmacy business, the person belongs to one of the classes of individual specified in Part 4 of Schedule 16 and is designated in writing for the purpose of the administration of medicinal products under the PGD—

(a)in the case of an arrangement with a body referred to in paragraph (1)(a)(i) to (v) (health bodies), on behalf of that body;

(b)in the case of an arrangement with a body referred to in paragraph (1)(a)(vi) to (ix) (a police force, the Police Service of Northern Ireland, a prison service and Her Majesty's Forces), by or on behalf of a person specified in column 2 of Part 3 of Schedule 16 against the entry in column 1 for that body; and

(c)in the case of an arrangement with an authority or person referred to in paragraph (1)(a)(x) (independent hospitals etc)—

(i)by or on behalf of the registered provider, or

(ii)if there is a relevant manager for the establishment or agency in question, by that manager.

[F1039(7) Condition F is that when the prescription only medicine is supplied or (as the case may be) administered [F1040, either an authorisation by the licensing authority on a temporary basis under regulation 174 or]—

(a)in Northern Ireland, a UKMA(NI), UKMA(UK)F1041..., Article 126a authorisation, certificate of registration, THR(NI) or THR(UK) [F1042or, in the case of a listed NIMAR product, a UKMA(UK) or UKMA(GB),] or

(b)in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),

is in force in relation to it.]

[F1043(8) Regulation 220 does not apply to the supply, or administration, of a prescription only medicine used for [F1044vaccination against an infectious disease] where paragraph (1)(a) and (b) applies and conditions A to F are met.

F1045(9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Textual Amendments

F1038Words in reg. 233(5)(a) substituted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 7(3) and words in reg. 233(5)(a) substituted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 7(3)

F1039Reg. 233(7) substituted (31.12.2020) by S.I. 2019/775, reg. 191 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 145)

Exemption for supply etc of products under a PGD to assist the police etcU.K.

234.—(1) Regulations 214, 220 and 221 do not apply to the supply or administration of a medicinal product by an individual belonging to one of the classes specified in Part 4 of Schedule 16 in accordance with the following conditions.

(2) Condition A is that the individual supplies or (as the case may be) administers the product to assist the provision of health care by, on behalf of, or under arrangements made by, one of the following bodies (“the relevant body”)—

(a)a police force in England and Wales or in Scotland;

(b)the Police Service of Northern Ireland;

[F1046(c)a prison service;

(d)Her Majesty’s Forces; or

(e)a contractor carrying out helicopter search and rescue operations on behalf of the Maritime and Coastguard Agency.]

(3) Condition B is that the product is supplied for the purpose of being administered to a person in accordance with a patient group direction (“PGD”).

(4) Condition C is that the PGD relates to the supply or (as the case may be) the administration of a description or class of medicinal product to assist the provision of health care by, on behalf of, or under arrangements made by, the relevant body.

(5) Condition D is that the PGD has effect at the time at which the product is supplied or (as the case may be) administered.

(6) Condition E is that the PGD contains the particulars specified in Part 1 of Schedule 16 (but with the omission of paragraph 4 in the case of a PGD relating to administration only).

(7) Condition F is that the PGD is signed—

(a)by or on behalf of a person specified in column 2 of Part 3 of Schedule 16 against the entry in column 1 for the relevant body; and

(b)where the relevant body is a police force or the Police Service of Northern Ireland, by a doctor who is not employed or engaged by, and does not provide services under arrangements made with, any police force or the Police Service of Northern Ireland.

(8) Condition G is that the individual who supplies the product is designated in writing by or on behalf of the relevant body for the purpose of the supply or (as the case may be) the administration of medicinal products under the PGD.

[F1047(9) Condition H is that when the product is supplied [F1048, either an authorisation by the licensing authority on a temporary basis under regulation 174 or]—

(a)in Northern Ireland, a UKMA(NI), UKMA(UK)F1049..., Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), [F1050or, in the case of a listed NIMAR product, a UKMA(UK) or UKMA(GB),] or

(b)in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),

is in force in relation to it.]

Textual Amendments

F1046Reg. 234(2)(c)-(e) substituted for reg. 234(2)(c)(d) (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 5(2) and reg. 234(2)(c)-(e) substituted for reg. 234(2)(c)(d) (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 5(2)

Exemption for sale, supply or administration by certain personsU.K.

235.—(1) Regulation 214(1) does not apply to the sale or supply by a person of a prescription only medicine if—

(a)the person is listed in column 1 of Part 1 of Schedule 17;

(b)the prescription only medicine is listed in the corresponding paragraph in column 2 of that Part; and

(c)the condition specified in the corresponding paragraph in column 3 of that Part is met.

(2) Regulation 214(1) does not apply to the supply by a person of a prescription only medicine if—

(a)the person is listed in column 1 of Part 2 of Schedule 17;

(b)the prescription only medicine is listed in the corresponding paragraph in column 2 of that Part; and

(c)the condition specified in the corresponding paragraph in column 3 of that Part is met.

(3) Regulation 214(1) does not apply to the administration by a person of a prescription only medicine if—

(a)the person is listed in column 1 of Part 3 of Schedule 17;

(b)the product is a prescription only medicine for parenteral administration listed in the corresponding paragraph in column 2 of that Part; and

(c)the condition specified in the corresponding paragraph in column 3 of that Part is met.

(4) Regulation 220 does not apply to the sale, supply or offer for sale or supply by a person of a medicinal product if—

(a)the person is listed in column 1 of Part 4 of Schedule 17;

(b)the product is a prescription only medicine or pharmacy medicine listed in the corresponding paragraph in column 2 of that Part; and

(c)the condition specified in the corresponding paragraph in column 3 of that Part is met.

(5) Regulation 220 does not apply to the supply by a person of a medicinal product if—

(a)the person is listed in column 1 of Part 5 of Schedule 17;

(b)the product is a prescription only medicine or pharmacy medicine listed in the corresponding paragraph in column 2 of that Part; and

(c)the condition specified in the corresponding paragraph in column 3 of that Part is met.

(6) Regulation 221 does not apply to the sale, supply, or offer for sale or supply by a person of a medicinal product if—

(a)the person is listed in column 1 of Part 4 of Schedule 17;

(b)the product is a medicinal product subject to general sale that is listed in the corresponding paragraph in column 2 of that Part; and

(c)the condition specified in the corresponding paragraph in column 3 of that Part is met.

(7) Regulation 221 does not apply to the sale, supply, or offer for sale or supply by a person of a medicinal product if—

(a)the person is listed in column 1 of Part 5 of Schedule 17;

(b)the product is a medicinal product subject to general sale that is listed in the corresponding paragraph in column 2 of that Part; and

(c)the condition specified in the corresponding paragraph in column 3 of that Part is met.

F1051(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F1052Exemption for supply or administration of certain medicines used for vaccinationU.K.

235A.—(1) Regulations 214, 220 and 221 do not apply to the supply or administration of a medicinal product used for vaccination in accordance with conditions A to F by—

(a)a public health agency;

(b)a health authority or special health authority;

(c)an NHS Trust;

(d)an NHS Foundation Trust;

(e)a local authority in the exercise of public health functions (within the meaning of the National Health Service Act 2006); or

(f)a person under relevant arrangements.

(2) Condition A is that the medicinal product is used for vaccination—

(a)for the purpose of providing protection against an infectious disease; and

(b)as part of a vaccination programme that has been approved by the Secretary of State, the Scottish Ministers, the Welsh Ministers or the Minister of Health in Northern Ireland.

(3) Condition B is that the medicinal product is supplied for the purpose of being administered to a person in accordance with the requirements of a vaccine group direction which has been produced by a public health agency.

(4) Condition C is that the vaccine group direction—

(a)is signed by or on behalf of—

(i)in the case of supply or administration by a body listed in paragraph (1)(a) to (e), a senior manager of that body, or

(ii)in the case of supply or administration by a person as mentioned in paragraph (1)(f), a senior manager of the body that enters into the relevant arrangements with that person; and

(b)has effect at the time at which the medicinal product is administered.

(5) Condition D is that the individual who administers the medicinal product is either at the same location and under the supervision of an individual who, or is an individual who—

(a)has—

(i)assessed and determined that the person who is to receive the medicinal product is eligible for the treatment, and

(ii)obtained and recorded the informed consent of, or in respect of, the person who is to receive the medicinal product; and

(b)belongs to one of the classes of individuals specified in Part 4 of Schedule 16.

(6) Condition E is that the vaccine group direction contains the particulars specified in Part 1 of Schedule 16, and specifies—

(a)the classes of persons permitted to administer medicinal products under the direction;

(b)the process by which a person of a specified class is designated, and by whom, as a person permitted to administer medicinal products under the direction; and

(c)requirements, where appropriate, for the supervision of a person who, on any particular occasion, administers a medicinal product under the direction.

(7) Condition F is that, when the medicinal product is administered, there is in force in relation to it—

(a)a UK marketing authorisation; or

(b)an authorisation by the licensing authority on a temporary basis under regulation 174.

(8) In this regulation—

“a public health agency” means—

(a)

Public Health Scotland in respect of Scotland;

(b)

Public Health Wales in respect of Wales;

(c)

the UK Health Security Agency in respect of England;

(d)

the Public Health Agency in respect of Northern Ireland;

“relevant arrangements” has the meaning given in regulation 19(4C) (exemptions from requirement for wholesale dealer’s licence);

“senior manager” means a person who plays a significant role (irrespective of whether other individuals also do so) in—

(a)

the making of decisions about how the whole or a substantial part of the activities of the body in question are to be managed or organised, or

(b)

the actual managing or organising of the whole or a substantial part of those activities.]

Textual Amendments

Exemptions in relation to specific kinds of productU.K.

Products consisting of or containing aloxiprin, aspirin or paracetamolU.K.

236.  Regulation 214(1) does not apply to a medicinal product that is a prescription only medicine by virtue of paragraph 1(e) of Schedule 1 (non-effervescent aloxiprin, aspirin or paracetamol) if the quantity of the product sold or supplied to a person at any one time does not exceed 100 tablets or capsules.

Products consisting of or containing pseudoephedrine salts or ephedrine base or saltsU.K.

237.—(1) Regulation 214(1) does not apply to a medicinal product that is a prescription only medicine by virtue of paragraph 1(f) of Schedule 1 (products consisting of or containing pseudoephedrine salts or ephedrine base or salts) if conditions A and B are met.

(2) Condition A is that the product is not sold or supplied at the same time as another medicinal product that consists of or contains—

(a)in the case of pseudoephedrine salts, ephedrine base or salts; or

(b)in the case of ephedrine base or salts, pseudoephedrine salts.

(3) Condition B is that the medicinal products sold or supplied to a person at any one time do not in total contain more than—

(a)in the case of pseudoephedrine salts, 720mg pseudoephedrine salts; or

(b)in the case of ephedrine base or salts, 180mg ephedrine base or salts.

[F1053Appropriate suppliers of naloxone productsU.K.

237A.—(1) Regulations 214(1) and 220 do not apply to the supply of a naloxone product by an individual who is an appropriate supplier of naloxone products, if it is for an appropriate purpose.

(2) For the purposes of paragraph (1), the following are appropriate suppliers of naloxone products—

(a)a person employed or engaged in the provision of drug treatment services provided by or on behalf of, or under arrangements with, one of the following—

(i)an NHS body,

(ii)a local authority,

(iii)the Secretary of State, or

(iv)the Public Health Agency;

(b)a person employed or engaged in the provision of services as part of the medical services of His Majesty’s forces;

(c)a person employed or engaged by, or by an entity commissioned to provide drug treatment services by or on behalf of, one of the bodies listed below, if the listed body is satisfied that the person has undergone appropriate training in the storage and supply of naloxone products—

(i)a police force in England, Wales or Scotland,

(ii)the Police Service of Northern Ireland,

(iii)a prison service,

(iv)a provider of probation services, or

(v)a provider of youth justice services;

(d)a person who is one of the following—

(i)a pharmacist,

(ii)in England, Wales or Scotland, a registered pharmacy technician,

(iii)a registered nurse,

(iv)a registered midwife, or

(v)a registered paramedic,

if that person has undergone appropriate training in the storage and supply of naloxone products; and

(e)a person employed or engaged by a local naloxone provider, if that local naloxone provider is satisfied that the person has undergone appropriate training in the storage and supply of naloxone products.

(3) For the purposes of this regulation, a local naloxone provider is an entity that has valid arrangements in place (“local naloxone arrangements”) with a naloxone supply network co-ordinator for the supply of naloxone products for an appropriate purpose.

(4) For the purposes of this regulation, a naloxone supply network co-ordinator is an entity that has valid arrangements in place (“network creation arrangements”) with an appropriate national body as part of which the naloxone supply network co-ordinator creates and maintains a network of local naloxone providers that are willing to supply naloxone products for an appropriate purpose.

(5) For—

(a)local naloxone arrangements to be valid, a naloxone supply network co-ordinator must ensure that any putative local naloxone arrangements that it has contain arrangements that ensure; and

(b)network creation arrangements to be valid, the appropriate national body must ensure that any putative network creation arrangements that it has contain arrangements that ensure,

the outcomes listed in paragraph (6).

(6) Those outcomes are—

(a)that only persons who are employed or engaged by the putative local naloxone provider and who have undergone appropriate training in the storage and supply of naloxone products are able to supply them under the putative local naloxone arrangements;

(b)that any requirements that the appropriate national body has in respect of training in the storage and supply of naloxone products which are relevant to supply in accordance with this regulation are included in the putative local naloxone arrangements, and any such requirements are appropriate training for the purposes of paragraph (2)(e) (but see paragraph (8));

(c)that a record is kept by the putative local naloxone provider of all the persons employed or engaged by them who are able to supply naloxone products under the putative local naloxone arrangements, and of their relevant training;

(d)that the putative local naloxone provider has a named individual responsible at all times for—

(i)the storage, any handling relating to storage and any handling relating to supply of naloxone products by or on behalf of the putative local naloxone provider under their putative local naloxone arrangements, and

(ii)the maintenance of appropriate records of those activities by the putative local naloxone provider;

(e)that any requirements that the appropriate national body has in respect of storage and any handling relating to supply of naloxone products by local naloxone providers, which arise out of or relate to supply in accordance with this regulation, are included in the putative local naloxone arrangements; and

(f)that any requirements that the appropriate national body has in respect of the processing of information by local naloxone providers, including in respect of—

(i)the records to be kept as part of local naloxone arrangements,

(ii)the information to be derived from those records, and

(iii)the provision of information to naloxone supply network co-ordinators, and the occasions on which and the frequency with which to do so,

which arise out of or relate to supply in accordance with this regulation, are included in the putative local naloxone arrangements.

(7) For network creation arrangements to be valid, the appropriate national body must also ensure that any putative network creation arrangements that it has contain arrangements that ensure the following outcomes—

(a)that any requirements that the appropriate national body has in respect of the processing of information by naloxone supply network co-ordinators, including in respect of—

(i)the records to be kept as part of the network creation arrangements,

(ii)the information to be derived from those records, and

(iii)the provision of information to the appropriate national body, and the occasions on which and the frequency with which to do so,

which arise out of or relate to supply in accordance with this regulation, are included in the putative network creation arrangements; and

(b)that any requirements that the appropriate national body has in respect of who may be a local naloxone provider, and how their status as such is recorded or advertised, are included in the putative network creation arrangements.

(8) In order for training in the storage and supply of naloxone products to be appropriate for the purposes of this regulation, its outcome must be that a person completing the training successfully (T) has the following competencies—

(a)understanding of the legal framework for supply in accordance with this regulation which is sufficient for the purposes of ensuring that T is able to administer naloxone products lawfully and where appropriate to supply them to another person for that other person to administer them lawfully, having been trained to do so by T;

(b)understanding of the safe storage and safe handling of naloxone products which is sufficient for the purposes of ensuring—

(i)that T is able to store and handle naloxone products safely and without compromising their efficacy, and

(ii)if T is to supply those products to another person for that other person to store and handle them, that the other person is able to store and handle them safely, and without compromising their efficacy, having been trained to do so by T; and

(c)understanding of how and when to administer naloxone products which is sufficient for the purposes of ensuring—

(i)that T is able to do so safely, effectively and when appropriate, and

(ii)if T is to supply those products to another person for that other person to administer them, that the other person is able to administer them safely, effectively and when appropriate, having been trained to do so by T,

and if the appropriate national body for where a supply takes place has determined that that is the outcome of particular training for a particular (or any) category of person, then for where that supply takes place that determination is conclusive evidence, or in Scotland sufficient evidence, that the training is appropriate training for that category of person.

(9) The following are appropriate purposes for the purposes of this regulation—

(a)the naloxone product is needed by the person to whom or for whom it is supplied for the purpose of saving life in an emergency;

(b)in the reasonable expectation of the appropriate supplier of naloxone, the supply of the naloxone product is to enable it to be kept at a place where a person resides or which they frequent, in circumstances where that person may need, at that place—

(i)to administer it to themselves in an emergency for the purposes of saving their own life, or

(ii)to administer it to another person, or to have it administered to them, in accordance with regulation 238; or

(c)in the reasonable expectation of the appropriate supplier of naloxone, the supply of the naloxone product is to enable it to be carried about by the person to or for whom it is supplied, that person being a person who may need it—

(i)to administer it to themselves in an emergency for the purposes of saving their own life, or

(ii)to administer it to another person, or to have it administered to them, in accordance with regulation 238.

(10) Where, pursuant to this regulation, an appropriate supplier of naloxone mentioned in paragraph (2)(a) to (d) supplies a naloxone product—

(a)that appropriate supplier of naloxone;

(b)a provider of drug treatment services, medical services or other health care services that employs or engages the appropriate supplier of naloxone, if it is the entity that supplied the supplier with the naloxone product; or

(c)a body listed in paragraph (2)(a) or (c), where that body provided or commissioned the drug treatment services or other health care services as part of which the appropriate supplier of naloxone supplied the naloxone product,

may provide an appropriate national body with any information about that supply, if that type of information, or information derived from that type of information, is information that a naloxone supply network co-ordinator would be required to supply to that body under network creation arrangements, it (or the information derived from it) being information included in requirements that the appropriate national body has as mentioned in paragraph (7)(a)(iii).

(11) For the purposes of section 8(c) of the Data Protection Act 2018 (lawfulness of processing: public interest etc), provision of information in the circumstances described in paragraph (10) is to be considered necessary for the performance of a task carried out in the public interest.

(12) For the purposes of this regulation, the following are appropriate national bodies—

(a)in England, the Secretary of State;

(b)in Scotland, the Scottish Ministers;

(c)in Wales, the Welsh Ministers or Public Health Wales;

(d)in Northern Ireland, the Public Health Agency or the Department of Health in Northern Ireland.

(13) For the purposes of this regulation and regulation 238, any use of a naloxone product that is indicated in a marketing authorisation for the product is to be treated as being for the purpose of saving life, even if the use is for, or partially for, diagnosis.]

Textual Amendments

Administration of certain medicines in an emergencyU.K.

238.  Regulation 214(2) does not apply to the administration of a prescription only medicine specified in Schedule 19 where this is for the purpose of saving life in an emergency.

Administration of smallpox vaccineU.K.

239.—(1) Regulation 214(2) does not apply to the administration of smallpox vaccine if condition A or B is met.

(2) Condition A is that—

(a)the vaccine has been supplied by, on behalf of, or under arrangements made by—

(i)the Secretary of State,

(ii)the Scottish Ministers,

(iii)the Welsh Ministers,

(iv)the Department of Health, Social Services and Public Safety, or

(v)an NHS body; and

(b)the vaccine is administered for the purpose of providing protection against smallpox virus in the event of a suspected or confirmed case of smallpox in the United Kingdom.

(3) Condition B is that—

(a)the vaccine has been supplied by, on behalf of, or under arrangements made by, Her Majesty's Forces; and

(b)the vaccine is administered for the purpose of providing protection against smallpox virus to members of Her Majesty's Forces or other persons employed or engaged by them.

[F1054Radioactive medicinal productsU.K.

240.—(1) Regulation 214(2) does not apply to—

(a)a radioactive substance, administration of which results in a medical exposure; or

(b)any other prescription only medicine if it is being administered in connection with a medical exposure,

if Conditions A to E are met.

(2) Condition A is that the prescription only medicine is administered by an operator acting in accordance with the procedures and protocols referred to—

(a)in England and Wales and Scotland, in regulation 6(1) and (4) of the Ionising Radiation (Medical Exposure) Regulations 2017 which apply to the exposure;

(b)in Northern Ireland, in regulation 6(1) and (4) of the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018 which apply to the exposure.

(3) Condition B is that the medical exposure has been authorised by—

(a)an IRME practitioner; or

(b)where it is not practical for an IRME practitioner to authorise the exposure, an operator acting in accordance with written guidelines issued by an IRME practitioner.

(4) Condition C is that—

(a)in England and Wales and Scotland, the IRME practitioner mentioned in sub-paragraph (a) or (b) of paragraph (3) is the holder of a licence issued under the Ionising Radiation (Medical Exposure) Regulations 2017;

(b)in Northern Ireland, the IRME practitioner mentioned in sub-paragraph (a) or (b) of paragraph (3) is the holder of a licence issued under the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018.

(5) Condition D is that the prescription only medicine is not a product subject to special medical prescription.

(6) Condition E is that, in the case of a prescription only medicine that is not a radioactive substance, it is specified in the protocols referred to in paragraph (2).

(7) In this regulation—

“IRME practitioner” means—

(a)

in relation to a medical exposure in England and Wales and Scotland, a practitioner for the purposes of the Ionising Radiation (Medical Exposure) Regulations 2017;

(b)

in relation to a medical exposure in Northern Ireland, a practitioner for the purposes of the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018;

“medical exposure” has the same meaning—

(a)

in England and Wales and Scotland as in the Ionising Radiation (Medical Exposure) Regulations 2017;

(b)

in Northern Ireland as in the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018;

“radioactive substance” has the same meaning—

(a)

in England and Wales and Scotland as in the Ionising Radiation (Medical Exposure) Regulations 2017;

(b)

in Northern Ireland as in the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018.]

Textual Amendments

Exemptions in respect of certain herbal remediesU.K.

241.—(1) Regulations 220 and 221 do not apply to the sale or supply, or offer for sale or supply by a person (“A”) of a herbal medicinal product if—

(a)the product does not contain a substance listed in Part 1 of Schedule 20;

(b)the product does not contain a substance listed in column 1 of Part 2 of that Schedule, unless the product is sold or supplied—

(i)in the case of a product for which there is a corresponding entry in column 2 of that Part, in or from containers or packages labelled to show a dose not exceeding the maximum dose or maximum daily dose specified in that entry, and

(ii)in the case of a product for which there is a corresponding entry in column 3 of that Part, with the percentage of the substance in the product not exceeding that specified in that entry;

(c)the sale or supply, or offer for sale or supply, takes place on premises occupied by A and from which A can exclude the public; and

(d)the product is for administration to a person (“B”) and A has been requested by or on behalf of B and in B's presence to use A's judgment as to the treatment required.

(2) A reference in this regulation to a substance listed in either Part of Schedule 20 is a reference to a substance that is obtained from any botanical source listed in either Part.

Exemption for medicinal products at high dilutionU.K.

242.—(1) Regulations 220 and 221 do not apply to the sale or supply, or offer for sale or supply by a person (“P”) of a medicinal product if—

(a)the medicinal product is neither for parenteral administration nor a [F1055product subject to special medical prescription];

(b)paragraph (2) applies to the medicinal product; and

(c)P has been requested by or on behalf of a particular person and in that person's presence to use P's own judgment as to the treatment required.

(2) This paragraph applies to a medicinal product that consists solely of one or more unit preparations of—

(a)any substance where the unit preparation has been diluted to at least one part in a million (6x);

(b)any substance that is listed in Part 1 of Schedule 21 where the unit preparation has been diluted to at least one part in a thousand (3x); or

(c)any substance that—

(i)is the active substance of a medicine that is subject to general sale;

(ii)is listed in Part 3 of Schedule 21; or

(iii)in the case of a medicinal product for external use only, is listed in Part 4 of Schedule 21,

where the unit preparation has been diluted to at least one part in ten (1x).

(3) Regulation 220 does not apply to the sale, supply, or offer for sale or supply by a person of a medicinal product if—

(a)the medicinal product is neither for parenteral administration nor a [F1056product subject to special medical prescription];

(b)paragraph (4) applies to the medicinal product; and

(c)the conditions in regulation 221 are met.

(4) This paragraph applies to a medicinal product that consists solely of one or more unit preparations of—

(a)any substance where the unit preparation has been diluted to at least one part in a million million (6c);

(b)any substance that is listed in Part 2 of Schedule 21 where the unit preparation has been diluted to at least one part in a million (6x); or

(c)any substance that—

(i)is the active substance of a medicine that is subject to general sale;

(ii)is listed in Part 3 of Schedule 21; or

(iii)in the case of a medicinal product for external use only, is listed in Part 4 of Schedule 21,

where the unit preparation has been diluted to at least one part in ten (1x).

Textual Amendments

F1055Words in reg. 242(1)(a) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(g) and words in reg. 242(1)(a) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(g)

F1056Words in reg. 242(3)(a) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(g) and words in reg. 242(3)(a) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(g)

Exemption for certain homoeopathic medicinal productsU.K.

243.—(1) Regulations 220 and 221 do not apply to the sale or supply, or offer for sale or supply by a person (“P”) of a medicinal product if—

(a)a certificate of registration is in force in relation to the product;

(b)the product is not an excluded product; and

(c)P has been requested by or on behalf of a particular person and in that person's presence to use P's own judgment as to the treatment required.

(2) Regulation 220 does not apply to the sale or supply, or offer for sale or supply by a person (“P”) of a medicinal product if—

(a)a certificate of registration is in force in relation to the product;

(b)the product is not an excluded product; and

(c)the conditions in regulation 221 are met.

(3) In this regulation “excluded product” means a product that is promoted, recommended or marketed—

(a)for use as an anthelmintic;

(b)for parenteral administration;

(c)for use as eye drops;

(d)for use as an eye ointment;

(e)for use as an enema;

(f)for use wholly or mainly for irrigation of wounds or of the bladder, vagina or rectum; or

(g)for administration wholly or mainly to children being a preparation of aloxiprin or aspirin.

Other exemptionsU.K.

Exemption in cases involving another's defaultU.K.

244.—(1) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a person if the person, having exercised all due diligence, believes on reasonable grounds that the product is not a prescription only medicine.

(2) Regulation 220 does not apply to the sale or supply, or offer for sale or supply of a medicinal product by a person if—

(a)the person, having exercised all due diligence, believes on reasonable grounds that the product is subject to general sale;

(b)that belief is due to the act or default of another person; and

(c)the conditions in regulation 221 are met in relation to the sale or supply, or offer for sale or supply of the product.

Exemption in case of forged prescriptionU.K.

245.  Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a forged prescription if the pharmacist, having exercised all due diligence, believes on reasonable grounds that the prescription is genuine.

Exemption where requirements for prescriptions not metU.K.

246.  Regulation 214(1) does not apply to the sale or supply of a prescription only medicine otherwise than in accordance with a prescription given by an appropriate practitioner if—

(a)the sale or supply is otherwise than in accordance with such a prescription because a condition in regulation 217, 218[F1057, 219 or 219A] is not met; and

(b)the person selling or supplying the prescription only medicine, having exercised all due diligence, believes on reasonable grounds that the condition is met.

Textual Amendments

F1057Words in reg. 246(a) substituted (E.W.S.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 6 and words in reg. 246(a) substituted (N.I.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 6

Exemption for supply in the event or anticipation of pandemic diseaseU.K.

247.—(1) Regulations 214(1), 220 and 221 do not apply to the supply of a medicinal product that meets the following conditions.

(2) Condition A is that the supply is made whilst a disease is, or in anticipation of a disease being imminently—

(a)pandemic; and

(b)a serious risk, or potentially a serious risk, to human health.

(3) Condition B is that the supply is accordance with a protocol that—

(a)is approved by the Ministers [F1058or an NHS body];

(b)specifies [F1059how the medicinal product is to be used for the prevention of or as a] treatment for the disease; and

(c)contains requirements as to the recording of—

(i)the name of the person who supplies the product to the person to be treated (“the patient”) or to a person acting on the patient's behalf, and

(ii)evidence that the product was supplied to the patient or to a person acting on the patient's behalf.

[F1060(4) A function of the Ministers under this regulation may be exercised by either of them acting alone or both of them acting jointly (and the reference in this regulation to “the Ministers” is to be read accordingly).]

Textual Amendments

Protocols relating to coronavirus and influenza vaccinations and immunisationsU.K.

F1061247A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Exemption for certain collection and delivery arrangementsU.K.

248.—(1) Regulations 220 and 221 do not apply to the supply of a medicinal product on premises that are not a registered pharmacy where the supply—

(a)is in accordance with a prescription issued by a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber [F1062, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber] [F1063, paramedic independent prescriber] or optometrist independent prescriber; and

(b)forms part of a collection and delivery arrangement used by a person who lawfully conducts a retail pharmacy business.

(2) In this regulation “collection and delivery arrangement” means an arrangement whereby a person may—

(a)take or send a prescription given by a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber [F1064, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber] [F1065, paramedic independent prescriber] or optometrist independent prescriber to premises other than a registered pharmacy and which are capable of being closed by the occupier to exclude the public; and

(b)collect or have collected on his or her behalf from such premises a medicinal product prepared or dispensed in accordance with such a prescription at a registered pharmacy by or under the supervision of a pharmacist [F1066or by a person who acts in accordance with regulation 220A or 220B].

Textual Amendments

F1062Words in reg. 248(1)(a) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 12(2) and words in reg. 248(1)(a) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 12(2)

F1063Words in reg. 248(1)(a) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 10(2) and words in reg. 248(1)(a) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 10(2)

F1064Words in reg. 248(2)(a) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 12(3) and words in reg. 248(2)(a) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 12(3)

F1065Words in reg. 248(2)(a) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 10(3) and words in reg. 248(2)(a) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 10(3)

CHAPTER 4U.K.Miscellaneous provisions, offences and disqualification

Miscellaneous provisionsU.K.

Restrictions on persons to be supplied with medicinal productsU.K.

249.—(1) The holder of an authorisation of the kind referred to in paragraph (2) may not sell a prescription only medicine or a pharmacy medicine by way of wholesale dealing to a person who does not fall within a class specified in Schedule 22.

(2) Those authorisations are—

(a)a [F1067UK] marketing authorisation;

F1068(aa). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)a certificate of registration;

(c)a traditional herbal registration; and

(d)an Article 126a authorisation.

(3) A person may not, in the course of a business consisting (wholly or partly) of manufacturing medicinal products or of selling medicinal products by way of wholesale dealing, sell a prescription only medicine or a pharmacy medicine by way of wholesale dealing to a person who does not fall within a class specified in Schedule 22.

(4) This regulation is subject to regulation 250.

Textual Amendments

Exceptions to regulation 249U.K.

250.—(1) This regulation makes provision for exceptions to regulation 249.

(2) A person may sell by way of wholesale dealing a pharmacy medicine which is for the purpose of being administered to human beings in the course of a business to any person carrying on such a business.

(3) A person may sell by way of wholesale dealing a pharmacy medicine to which a general sale exemption applies to any person who by virtue of that exemption may sell the pharmacy medicine by retail, or supply it in circumstances corresponding to retail sale, otherwise than by or under the supervision of a pharmacist [F1069or by a person who acts in accordance with regulation 220A or 220B (or an exemption in Chapter 3 of Part 12)].

(4) In paragraph (3) “general sale exemption” means an exemption from regulation 220 conferred by a provision of Chapter 3.

[F1070(4A) A person may, in the course of a business consisting (wholly or partly) of manufacturing medicinal products or of selling products by way of wholesale dealing, sell by way of wholesale dealing a prescription only medicine to any person who by virtue of [F1071regulation 235A or 247] may supply or administer that medicine in accordance with a [F1072direction or protocol of the type] mentioned in those regulations.]

[F1073(4B) A person may, in the course of a business consisting (wholly or partly) of manufacturing medicinal products, or of selling products by way of wholesale dealing, sell or supply by way of wholesale dealing a naloxone product that is a prescription only medicine to—

(a)providers of drug treatment services that have arrangements as mentioned in regulation 237A(2)(a);

(b)the medical services of His Majesty’s forces;

(c)the bodies mentioned in regulation 237A(2)(c); and

(d)local naloxone providers.]

(5) A person may sell by way of wholesale dealing to a person specified in column 1 of Parts 1 to 3 of Schedule 17 a prescription only medicine specified in relation to that person in column 2 of Parts 1 to 3 of that Schedule.

(6) A person may sell by way of wholesale dealing to a registered optometrist a product that is a prescription only medicine by reason only that it contains one or more of the following substances—

(a)amethocaine hydrochloride;

(b)lidocaine hydrochloride;

(c)oxybuprocaine hydrochloride; or

(d)proxymetacaine hydrochloride.

(7) A person may sell by way of wholesale dealing to an additional supply optometrist a product that is a prescription only medicine by reason only that it contains thymoxamine hydrochloride.

(8) A person may sell by way of wholesale dealing to a registered dispensing optician a prescription only medicine that—

(a)is required for use by a registered optometrist or doctor attending the optician's practice; and

(b)contains one or more of the following substances—

(i)amethocaine hydrochloride,

(ii)chloramphenicol,

(iii)cyclopentolate hydrochloride,

(iv)fusidic acid,

(v)lidocaine hydrochloride,

(vi)oxybuprocaine hydrochloride,

(vii)proxymetacaine hydrochloride, and

(viii)tropicamide.

(9) A person may sell by way of wholesale dealing to a registered dispensing optician a prescription only medicine that—

(a)is required for use by the optician in the course of a professional practice as a contact lens specialist; and

(b)contains one or more of the following substances—

(i)lidocaine hydrochloride,

(ii)oxybuprocaine hydrochloride, and

(iii)proxymetacaine hydrochloride.

(10) In this regulation—

“additional supply optometrist” means a person who is registered as an optometrist, and against whose name particulars of the additional supply speciality have been entered in the relevant register;

“contact lens specialist” means a person who is a registered dispensing optician and against whose name particulars of the contact lens speciality have been entered in—

(a)

the register of dispensing opticians maintained under section 7(b) of the Opticians Act 1989; or

(b)

the register of visiting dispensing opticians from relevant European States maintained under section 8B(1)(b) of that Act.

Textual Amendments

Compliance with standards specified in certain publicationsU.K.

251.—(1) A person may not sell a medicinal product that has been demanded by the purchaser by, or by express reference to, a particular name if—

(a)the name is a name at the head of the relevant monograph; and

(b)the product does not comply with the standard specified in that monograph.

(2) A person may not sell or supply a medicinal product in pursuance of a prescription given by a doctor or dentist in which the product required is described by, or by express reference to, a particular name if—

(a)the name is a name at the head of the relevant monograph; and

(b)the product does not comply with the standard specified in that monograph.

(3) A person may not sell or supply a medicinal product that has been offered or exposed for sale by, or by express reference to, a particular name if—

(a)the name is a name at the head of the relevant monograph; and

(b)the product does not comply with the standard specified in that monograph.

(4) If the particular name referred to in paragraph (1), (2) or (3) is that of an active ingredient of the product, the product does not comply with the standard specified in the relevant monograph if, in so far as it consists of that ingredient, it does not comply with that standard.

(5) See regulation 252 for the meaning of certain expressions used in this regulation.

[F1074(6) In paragraph (1), (2) or (3) a product is to be treated as complying with the standard specified in the relevant monograph where—

(a)the product complies with the standard specified in a relevant marketing authorisation for the product concerned, and

(b)the standard specified in that marketing authorisation does not comply with the standard specified in the relevant monograph.

(7) In paragraph (6), “relevant marketing authorisation” means—

F1075(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)an authorisation granted by the licencing authority under Chapter 4 of Title III to the 2001 Directive; or

(c)a [F1076UKMA(UK)(Category 2)] granted under the unfettered access route.]

Textual Amendments

Compliance with standards specified in certain publications: supplementaryU.K.

252.—(1) Where, together with the particular name specified as described in paragraph (1), (2) or (3) of regulation 251, there was specified a particular edition of a particular publication, “the relevant monograph” in that paragraph means—

(a)the monograph (if any) headed by the name in that edition; or

(b)if there is no such monograph, the appropriate current monograph (if any) headed by that name.

(2) Where, together with the particular name specified as described in paragraph (1), (2) or (3) of regulation 251, there was specified a particular publication, but not an edition of that publication, “the relevant monograph” in that paragraph means—

(a)the monograph (if any) headed by the name in the current edition; or

(b)if there is no monograph of the kind mentioned in sub-paragraph (a), the appropriate current monograph (if any) headed by that name; or

(c)if there is no monograph of the kinds mentioned in sub-paragraphs (a) or (b), the monograph headed by that name in the latest edition of the specified publication that contained a monograph headed by that name.

(3) Where no publication was specified with the particular name specified as described in paragraph (1), (2) or (3) of regulation 251, “the relevant monograph” in that paragraph means the appropriate current monograph (if any).

(4) In this regulation “publication” means—

(a)the British Pharmacopoeia; or

(b)a compendium published under Part 15 (British Pharmacopoeia).

(5) In this regulation “current” means current at the time when the medicinal product is demanded, described in a prescription or offered or exposed for sale (as the case may be).

(6) In this regulation “the appropriate current monograph”, in relation to a particular name, means—

(a)the monograph (if any) headed by that name in the current edition of the British Pharmacopoeia; or

(b)if there is no such monograph, the monograph (if any) headed by that name in the current edition of a compendium published under Part 15 (British Pharmacopoeia).

(7) For the purposes of regulation 251 and this regulation, any monograph in an edition of a publication must be construed in accordance with any general monograph or notice, or any appendix, note or other explanatory material, that is contained in that edition and applies to that monograph.

Pharmacy recordsU.K.

253.—(1) A person lawfully conducting a retail pharmacy business must, in respect of every sale or supply of a prescription only medicine, make or cause to be made an entry in a written or computerised record kept for that purpose.

(2) An entry required by paragraph (1)—

(a)must state the particulars specified in Schedule 23; and

(b)subject to paragraph (3), must be made—

(i)on the day of the sale or supply, or

(ii)if that is not reasonably practicable, on the day following that day.

(3) Where the sale or supply is made under regulation 224 (emergency sale etc by pharmacist: prescriber unable to provide prescription), the particulars specified in paragraph 2(e) and (f) of Schedule 23 may be entered on the day that the prescription is received.

(4) Paragraphs (1) to (3) do not apply if any of the following apply—

(a)the sale or supply is in pursuance of a health prescription or a prescription for oral contraceptives;

(b)a separate record of the sale or supply is made in accordance with the Misuse of Drugs Regulations 2001 or the Misuse of Drugs Regulations (Northern Ireland) 2002;

(c)the sale is by way of wholesale dealing and the order or invoice relating to the sale or a copy of the order or invoice is retained by the person lawfully conducting the retail pharmacy business who makes the sale;

(d)in Scotland, the sale or supply is to a doctor for use in the circumstances referred to in paragraph 45 of Schedule 5 to the National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004 M61 (provision of drugs, medicines and appliances for immediate treatment or personal administration);

(e)in Northern Ireland, the sale or supply is to a doctor for use in the circumstances referred to in paragraph 47 of Schedule 5 to the Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004 M62 (provision of drugs, medicines and appliances for immediate treatment or personal administration).

(5) A person lawfully conducting a retail pharmacy business must preserve for a period of two years beginning immediately after the relevant date—

(a)the record kept under paragraphs (1) to (3);

(b)a prescription in pursuance of which a prescription only medicine has been sold or supplied other than—

(i)a health prescription, or

(ii)a prescription for a [F1077product subject to special medical prescription];

(c)an order or invoice referred to in paragraph (4)(c) or a copy of the order or invoice; and

(d)orders referred to in column 3 of Parts 1 to 3 of Schedule 17, except orders referred to in paragraph 3 of Part 1 of that Schedule.

(6) In paragraph (5) “the relevant date” means—

(a)in relation to sub-paragraph (a), the date on which the last entry is made in the record;

(b)in relation to sub-paragraphs (b), (c) and (d)—

(i)where the prescription only medicine was sold or supplied in accordance with a repeatable prescription, the date of the final sale or supply pursuant to that prescription, and

(ii)otherwise, the date on which the prescription only medicine was sold or supplied.

Textual Amendments

F1077Words in reg. 253(5)(b)(ii) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(h) and words in reg. 253(5)(b)(ii) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(h)

Marginal Citations

M62S.R. (NI) 2004 No. 140.

Prohibitions concerning traceability of treatment with advanced therapy medicinal productsU.K.

254.—(1) A person may not treat a patient with an advanced therapy medicinal product if there is not a system in place for patient and product traceability in relation to such treatment containing sufficient detail to enable the linking of the product to the patient who received it and vice versa.

(2) A person may not treat a patient with an advanced therapy medicinal product if the treatment involves a product which contains human cells or tissues and the traceability system referred to in paragraph (1) is not complementary to, and compatible with, the requirements [F1078imposed pursuant to—

(a)as regards gametes and embryos, sections 12(3), and 33A to 33D of, and paragraph 1 of Schedule 3A to, the Human Fertilisation and Embryology Act 1990;

(b)as regards blood cells, regulations 8, 9(e) and 14 of the Blood Safety and Quality Regulations 2005; and

(c)as regards other cells and tissues, regulations 13 and 16 of, and paragraph 1 of Schedule 2 to, the Human Tissue (Quality and Safety for Human Application) Regulations 2007].

(3) It is a defence to an offence of breach of paragraph (1) or, as the case may be, paragraph (2) if the person who treats a patient was assured in writing before the treatment was given that a system of traceability as described in paragraph (1) or, as the case may be, paragraph (2) was in place in relation to the treatment given by that person.

(4) A person may not give an assurance in writing to a person (“P”) who treats a patient with an advanced therapy medicinal product that a system of traceability as described in paragraph (1) or paragraph (2) is in place in relation to treatment with an advanced therapy medicinal product given by P if no such system is in place.

Textual Amendments

Offences relating to dealings with medicinal productsU.K.

255.—(1) A person is guilty of an offence if the person breaches any of the following provisions of this Part—

(a)regulation 214(1) (prohibition on sale etc of prescription only medicine otherwise than in accordance with prescription from appropriate practitioner);

(b)regulation 214(2) (prohibition on parenteral administration of prescription only medicine otherwise than by or under directions of appropriate practitioner);

(c)regulation 220 (prohibition on sale etc of medicinal product not subject to general sale F1079...);

(d)regulation 249 (prohibition on sale of prescription only medicine or pharmacy medicine by way of wholesale dealing to person not within Schedule 22);

(e)regulation 251 (compliance with standards specified in certain publications); or

(f)regulation 254 (prohibitions concerning traceability of treatment with advanced therapy medicinal products).

(2) A person is guilty of an offence if the person—

(a)is an appropriate practitioner by virtue of regulation 214; and

(b)gives a prescription or directions in respect of a medicinal product in relation to which the person is not an appropriate practitioner.

(3) A person is guilty of an offence if the person gives a prescription or directions or administers a medicinal product without meeting the conditions for doing so that apply to that person by virtue of regulation 215 (conditions to be met by supplementary prescriber).

(4) A person (“P”) is guilty of an offence if—

(a)P has in P's possession a medicinal product to which regulation 214(1) applies; and

(b)P intends to supply it otherwise than in accordance with a prescription of an appropriate practitioner.

(5) A person guilty of an offence under any of paragraphs (1) to (4) is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment to a fine, to imprisonment for a term not exceeding two years, or to both.

(6) A person is guilty of an offence if the person breaches—

(a)regulation 221 (prohibition on sale of medicinal product subject to general sale otherwise than in accordance with that regulation); or

(b)regulation 222 (prohibition on sale by automatic machine of medicinal product not subject to general sale).

(7) A person guilty of an offence under paragraph (6) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.

(8) A person is guilty of an offence if the person breaches regulation 253 (record-keeping requirements for persons carrying on a retail pharmacy business).

(9) A person guilty of an offence under paragraph (8) is liable on summary conviction to a fine not exceeding £400.

Textual Amendments

Enforcement notices relating to Commission Regulation 2016/161: persons authorised to supply medicinal products to the publicU.K.

F1080255A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Exception to Article 25 of Commission Regulation 2016/161: health care institutionsU.K.

F1081255B.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Offences relating to Commission Regulation 2016/161: management of the repository systemU.K.

F1082255C.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

DisqualificationU.K.

Disqualification on convictionU.K.

256.—(1) A court before which a person (“P”) is convicted of any offence under regulation 255(8) may order that P is disqualified from using the premises where that offence was committed for a period not exceeding 2 years if the following conditions are met.

(2) Condition A is that the offence was committed in a retail pharmacy business.

(3) Condition B is that the period of disqualification relates to the future use of the premises as a retail pharmacy business.

(4) Condition C is that the enforcement authority has made an application to the court for such an order.

(5) Condition D is that the court thinks it appropriate to grant an order having regard—

(a)to the gravity of the offence of which P has been convicted as mentioned in the preceding subsection;

(b)to the unsatisfactory nature of the premises; or

(c)to any offences under regulation 255(8) of which P has previously been convicted.

(6) Condition E is that the enforcement authority has not less than 14 days before the date of the hearing given P notice in writing of their intention to apply for such an order.

(7) If P uses the premises in respect of which an order under this regulation is in force for the purposes of a retail pharmacy business, P shall be guilty of an offence and liable on summary conviction to a fine not exceeding level 5 on the standard scale.

(8) At any time after the end of the period of six months beginning with the date on which an order under this regulation comes into force, P may apply to the court to revoke the order or to vary it by reducing the period of disqualification.

(9) On any application made under paragraph (8) of this regulation the court may—

(a)revoke or vary the order if it thinks it proper to do so having regard to all the circumstances of the case, including in particular the conduct of the applicant and any improvement in the state of the premises to which the order relates; or

(b)refuse to revoke or vary the order.

(10) If an application made by P under paragraph (8) is refused, no further application under that paragraph may be made within the period of three months beginning with the date of the refusal.

(11) The court determining an application under this regulation shall have power to order the applicant to pay the whole or any part of the costs of the application.

(12) In the application of this regulation to Scotland, for reference to an enforcement authority and to costs there shall be substituted respectively references to the procurator fiscal and to expenses.

[F1083PART 12AU.K.Sale of medicines to the public at a distance

Textual Amendments

F1083Pt. 12A inserted (coming into force in accordance with reg. 1(2) of the amending S.I.) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(2), 28

[F1084Application of PartU.K.

256ZA.  This part applies to Northern Ireland only.]

Textual Amendments

InterpretationU.K.

256A.—[F1085(1)] In this Part—

“common logo” means the common logo that is required to be clearly displayed on websites offering medicinal products for sale at a distance to the public in accordance with the requirements laid down in the implementing acts adopted by the Commission under Article 85c(3) of the 2001 Directive;

“information society services” means information society services as defined in Article 1(2) of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services;

“the list” means the list of persons who are entitled to supply medicinal products by information society services that is maintained on the website of the [F1086licensing authority];

F1087...

“website of the EMA” means the website of the EMA that—

(a)

gives explicit information to the viewer on the [F1088website of the licensing authority] containing information on persons authorised or entitled to supply medicinal products at a distance in [F1089Northern Ireland];

(b)

provides information on the purpose of the common logo;

(c)

provides background information about the risks related to medicinal products supplied illegally to the public by means of information society services;

(d)

provides information on Community legislation applicable to falsified medicinal products;

(e)

contains [F1090a hyperlink to the website of the licensing authority].

[F1091“website of the licensing authority” means a website of the licensing authority providing information on—

(a)

the national legislation applicable to the offering of medicinal products for sale at a distance to the public by information society services;

(b)

the differences between Northern Ireland and EEA States regarding classification of medicinal products and the conditions for their supply;

(c)

the purpose of the common logo;

(d)

the list of persons offering medicinal products for sale at a distance by means of information society services as well as their website addresses;

(e)

background information about the risks related to medicinal products supplied illegally to the public by means of information society services;

(f)

a hyperlink to the website of the EMA;]

[F1092(2) In this Part, references to selling a medicinal product at a distance to the public by means of information society services, however expressed, include supplying and offering to sell or supply a medicinal product at a distance to the public by means of information society services (and related expressions are to be interpreted accordingly).]

Textual Amendments

F1085 Reg. 256A renumbered as reg. 256A(1) (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 13(a) and reg. 256A renumbered as 256A(1) (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 13(a)

Person who may sell medicinal products by information society servicesU.K.

256B.—[F1093(A1) This regulation applies to a person who is an established service provider (as defined in regulation 2(1) of the Electronic Commerce (EC Directive) Regulations 2002) in Northern Ireland.]

(1) A person may not sell a medicinal product at a distance to the public by means of information society services unless that person satisfies the following conditions.

(2) Condition A is that the person is included on the list F1094....

[F1095(3) Condition B is that the product to be sold by information society services is covered by a UK marketing authorisation or an authorisation granted—

(a)under Regulation (EC) No 726/2004; or

(b)by a competent authority of the member State in which that product is destined to be sold.

(3A) Condition B does not apply to—

(a)a special medicinal product;

(b)a medicinal product where the product is the result of a process of manufacture to which regulation 17(1) does not apply by virtue of any provision of section 10 of the Medicines Act 1968; or

(c)a medicinal product where—

(i)the product is a result of a process of assembly of a medicinal product that is an authorised medicinal product within the meaning of regulation 3(15);

(ii)regulation 17(1) does not apply to the process of assembly by virtue of any provision of section 10 of the Medicines Act 1968;

(iii)the process of assembly results in a change in the presentation of the authorised medicinal product; and

(iv)by reason of the change in paragraph (iii) the product does not comply with condition B.]

(4) Condition C is that the person selling the medicinal product is authorised or entitled to sell to the public, including by information society services, medicinal products of that type or classification F1096....

(5) Condition D is that where the sale is to a member of the public in the United Kingdom, it is in accordance with regulations 214 (sale or supply of prescription only medicines), 220 (sale or supply of medicinal products not subject to general sale) and 221 (sale or supply of medicinal products subject to general sale).

(6) Condition E is that the person selling the medicinal product has given a valid notification to [F1097the licensing authority].

(7) Condition F is that the person selling medicinal products at a distance complies with the relevant provisions of the Electronic Commerce (EC Directive) Regulations 2002.

(8) A person has not given a valid notification for the purposes of paragraph (6) if—

(a)that person is not included on the list;

(b)[F1098that person’s entry on the list] is suspended by [F1099the licensing authority]; or

(c)[F1100the licensing authority] has been notified under regulation 256E(b) to remove that person from the list.

Textual Amendments

F1098Words in reg. 256B(8)(b) substituted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 14 and words in reg. 256B(8)(b) substituted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 14

Notification requirements for sellers of medicinal products at a distanceU.K.

256C.—(1) The [F1101licensing authority] may not enter a person’s details on the list unless it has been notified in accordance with paragraphs to (5).

(2) The notification must include—

(a)the name or corporate name of the person to be listed;

(b)information about—

(i)that person’s permanent address from which the activity of selling medicinal products by information society services is to be carried out,

(ii)the commencement date of the activity of selling medicinal products by information society services,

(iii)the address of the website used for the purposes of selling medicinal products by information society services,

(iv)all relevant [F1102information] necessary to identify the website, and

(v)information about the classification of all the medicinal products offered for sale at a distance.

(3) The notification shall—

(a)be in English; and

(b)unless paragraph (4) applies, in relation to the person whose details are to be entered on the list—

(i)be signed by that person, and

(ii)contain that person’s telephone number and e-mail address if this is available.

(4) Where the notification is made by another person (“A”) on behalf of the person whose details are to be entered on the list, the notification shall—

(a)contain the name and address of A;

(b)be signed by A; and

(c)contain the telephone number and e-mail address for A if this is available.

(5) The notification shall contain contact details for the site from which the activity of selling medicinal products by information society services is to be carried out including the—

(a)site address;

(b)name of person who may be contacted; and

(c)the telephone number and e-mail address of the person who may be contacted.

Textual Amendments

Procedure for listing persons who may supply medicinal products at a distanceU.K.

256D.—(1) If the [F1101licensing authority] receives a notification under regulation 256C it must accept or refuse to include that person on the list within the period of 90 days beginning immediately after the day on which the notification is received by the authority.

(2) Paragraph (1) applies only if the requirements of regulation 256C(2) have been met.

(3) Before determining if a person can be included on the list, the [F1101licensing authority] may require the person giving the notification to provide such information as [F1103the licensing authority] thinks necessary, within the period specified by [F1103the licensing authority].

(4) If a notice under paragraph (3) requires the person giving the notification to provide the [F1101licensing authority] with information, the information period is not to be counted for the purposes of paragraph (1).

(5) In paragraph (4), the “information period” means the period—

(a)beginning with the day on which the notice is given, and

(b)ending with the day on which—

(i)the [F1101licensing authority] receives the information; or

(ii)the person from whom the information is requested shows to the satisfaction of the [F1101licensing authority] that the information cannot be provided.

(6) The [F1101licensing authority] must give the person giving the notification a notice stating reasons for its decision in any case where—

(a)the [F1101licensing authority] refuses to include the person giving the notification on the list; or

(b)if the [F1101licensing authority] lists the person giving the notification otherwise that in accordance with the information supplied in the notification.

Textual Amendments

Removal of a person’s entry from the listU.K.

256E.  The [F1101licensing authority] may remove a person’s entry from the list if—

(a)regulation [F1104256I(1)(c)] applies; or

(b)a notification to remove the entry is received from the person on the list.

Textual Amendments

F1104Word in reg. 256E(a) substituted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 8 and word in reg. 256E(a) substituted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 8

Provision of information to the [F1101licensing authority] U.K.

256F.—(1) A person on the list must immediately inform the [F1101licensing authority] and, where applicable, the marketing authorisation holder, of medicinal products which that person—

(a)identifies as;

(b)knows or suspects; or

(c)has reasonable grounds for knowing or suspecting,

to be falsified.

(2) The person entered on the list must notify the [F1101licensing authority] of any change of circumstances which is material as regards that person’s entry on the list.

(3) The [F1101licensing authority] may give a notice to a person on the list, requiring that person to provide information of a kind specified in the notice within the period specified in the notice.

(4) A notice under paragraph (3) may not be given to a person on the list unless it appears to the [F1101licensing authority] that it is necessary for that competent authority to consider whether that person’s entry on the list should be varied, suspended or removed.

(5) A notice under paragraph (4) may specify information which the [F1101licensing authority] thinks necessary for considering whether the person’s entry on the list should be varied, suspended or removed.

Textual Amendments

Grant or refusal to list a personU.K.

256G.—(1) On receipt of a notification from a person to be included in the list—

(a)the [F1101licensing authority] must include that person on the list if that person complies with the requirements in regulation 256C(2) to (5); or

(b)if it considers necessary or appropriate to do so, the [F1101licensing authority] must refuse to include that person on the list having had regard to—

(i)the provisions of these Regulations, and

(ii)any EU obligation.

(2) The [F1101licensing authority] must give a notice stating the reasons for its decision in any case where [F1105the licensing authority]—

(a)refuses to include a person on the list; or

(b)includes a person in the list otherwise than in accordance with the notification and that person requests a statement of its reasons.

(3) Where the [F1101licensing authority] decides to include a person on the list [F1106the licensing authority] must ensure that the [F1107website of the licensing authority] includes—

(a)the name or corporate name of the person that is listed; and

(b)the person’s website address in the United Kingdom.

Textual Amendments

F1106Words in reg. 256G(3) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 197(7)(b)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 S.I. 2020/1488, reg. 1, Sch. 2 para. 151)

F1107Words in reg. 256G(3) substituted (31.12.2020) S.I. 2019/775, regs. 1, 197(7)(b)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 S.I. 2020/1488, reg. 1, Sch. 2 para. 151)

Conditions to be met by a person entered on the listU.K.

256H.—(1) A person entered on the list shall not sell a medicinal product at a distance by information society services unless the following conditions are satisfied.

(2) Condition A is that the person entered on the list must comply with regulation 256B.

(3) Condition B is that without prejudice to the information requirements set out in Directive 2000/31/EC of the European Parliament and of the Council on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market, (Directive on electronic commerce), the website used to sell medicinal products at a distance must contain—

(a)the contact details of the [F1101licensing authority] F1108...;

(b)a hyperlink to the [F1109website of the licensing authority].

(4) Condition C is that without prejudice to any implementing Acts adopted by the Commission under Article 85c(3) of the 2001 Directive the website used to sell medicinal products at a distance must contain the common logo which—

(a)is clearly displayed on every page of the listed person’s website that relates to medicinal products offered for sale at a distance; and

(b)contains a hyperlink to the entry of that person in the list.

Textual Amendments

Power to suspend, vary or remove a person’s entry on the listU.K.

256I.—(1) The [F1101licensing authority] may in accordance with regulation 256J—

(a)suspend a person’s entry on the list for such period as the authority thinks fit;

(b)vary a person’s entry on the list; or

(c)remove a person’s entry from the list.

(2) The suspension of person from the list may be—

(a)total;

(b)limited to medicinal products of one or more descriptions; or

(c)limited to medicinal products sold at a distance from specified premises or a specified part of any premises.

(3) The power conferred by this regulation may only be exercised on one or more of the following grounds—

(a)in relation to any information notified to the [F1101licensing authority] under regulation 256C as a result of which the person was included in the list—

(i)the information so supplied was false or incomplete in a material respect,

(ii)a material change of circumstances has occurred in relation to any of the matters stated in the notification;

(b)the person on the list has materially contravened a condition required to be met by a person entered on the list under regulation 256H; or

(c)the person on the list has without reasonable excuse failed to supply information to the [F1101licensing authority] with respect to their notification when required to do so under regulation 256F(3).

Textual Amendments

Procedure where the [F1101licensing authority] proposes to suspend, vary or remove a person’s entry on the listU.K.

256J.—(1) This regulation applies where—

(a)the provisions of regulation 256K do not apply; and

(b)the [F1101licensing authority] proposes to exercise the power in regulation 256I.

(2) The [F1101licensing authority] must notify the person on the list in writing of—

(a)its proposal;

(b)the reasons for it; and

(c)a specified date on which it is proposed that the suspension, variation or revocation should take effect.

(3) The specified date in paragraph (2)(c) must be no earlier than 28 days following the date of the notice given by the [F1101licensing authority].

(4) The person to whom notice is given under paragraph (2) may before the date specified in the notice—

(a)make written representations to the [F1101licensing authority] with respect to the proposal; or

(b)notify the [F1101licensing authority] that the person wishes that competent authority to submit the proposal to review upon oral representations.

(5) If person on the list makes written representations in accordance with sub-paragraph (4)(a) the [F1101licensing authority] must take those representations into account before making a decision in the matter.

(6) If the person on the list gives notice of the proposal to review upon oral representation in accordance with paragraph (4)(b)—

(a)Schedule 5 has effect; F1110...

F1110(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7) If the [F1101licensing authority] proceeds to suspend, vary or remove a person’s entry on the list in accordance with the provisions of regulation 256I it must give a notice to that person.

(8) The notice must—

(a)give particulars of the suspension, variation or removal; and

(b)give reasons for the decision to suspend, vary or remove the person’s entry on the list.

(9) Paragraphs (7) and (8) are without prejudice to any requirement of Schedule 5 as to notification.

Textual Amendments

Suspension of a person’s entry on the list in cases of urgencyU.K.

256K.—(1) The [F1101licensing authority] may immediately suspend a person’s entry on the list for a period not exceeding three months where it appears to [F1111the licensing authority] that in the interests of safety it is appropriate to do so.

(2) This paragraph applies where—

(a)a person’s entry on the list has been suspended under paragraph (1); and

(b)it appears to the [F1101licensing authority] that it is necessary to consider whether the person’s entry on the list should be—

(i)further suspended or varied, or

(ii)removed from the list.

(3) Where paragraph (2) applies, the [F1101licensing authority] must proceed as set out in regulation 256I (but this is subject to paragraph (4)).

(4) Paragraph (5) applies where, in circumstances where paragraph (2) applies, the [F1101licensing authority] proceeds as set out in regulation 256I and any proceedings under that regulation have not been finally disposed of before the end of the period for which the person’s entry was suspended under paragraph (1) or further suspended under paragraph (5).

(5) If it appears to the [F1101licensing authority] to be necessary in the interests of safety to do so, the authority may further suspend the person’s entry on the list for a period which (in the case of each further suspension) is not to exceed three months.

(6) In the event that any challenge against a decision under regulation 256I to suspend, vary or remove a person’s entry on the list is made on an application under regulation 322(4) (validity of decisions and proceedings), paragraph (5) shall apply, but this is without prejudice to regulation 322(6)(a) (interim order of the High Court).

Textual Amendments

Variation of a person’s entry on the list on the application of that personU.K.

256L.—(1) This regulation applies if a person entered on the list applies to the [F1101licensing authority] for a variation of the person’s entry on the list.

(2) The application must—

(a)be in writing;

(b)specify the variation requested;

(c)be signed by or on behalf of the applicant; and

(d)be accompanied by such information as may be required to enable the [F1101licensing authority] to consider the application.

(3) The [F1101licensing authority] must vary a person’s entry on the list or refuse to vary it within 30 days beginning with the day after the date when [F1112the licensing authority] receives the application.

(4) The [F1101licensing authority] may give a notice to the applicant requiring the applicant to supply further information in connection with the application within the period specified in the notice.

(5) If a notice under paragraph (4) requires the applicant to provide the [F1101licensing authority] with information, the information period is not to be counted for the purposes of paragraph (3).

(6) In paragraph (5), the “information period” means the period—

(a)beginning with the day on which notice under paragraph (4) is given; and

(b)ending with the day on which the [F1101licensing authority] receives the information or the applicant shows to [F1113the licensing authority's] satisfaction that the applicant is unable to provide it.

(7) Nothing in this regulation affects the powers conferred by regulations 256I and 256K.

Textual Amendments

Offences: breach of regulations and false informationU.K.

256M.—(1) A person is guilty of an offence if the person—

(a)contravenes regulation 256B(1); or

(b)offers medicinal products for sale at a distance otherwise than in accordance with the conditions in regulation 256H.

(2) A person is guilty of an offence if the person knowingly gives false information in—

(a)an application to be entered on the list in accordance with regulation 256C(2);

(b)an application for a variation in accordance with regulation 256L(2); or

(c)response to a notice under regulation 256L(4).

(3) A person is guilty of an offence if, without reasonable excuse, the person fails to comply with a notice under regulation 256F(3) or 256L(4).

(4) A person is guilty of an offence if that person fails to inform the [F1101licensing authority]—

(a)of a falsified medicinal product in accordance with regulation 256F(1); or

(b)about a material change of circumstances in accordance with regulation 256F(2).

(5) It is a defence for a person charged with an offence under paragraph (4) to show that the person exercised all due diligence to avoid committing the offence.

Textual Amendments

PenaltiesU.K.

256N.—(1) A person guilty of an offence under regulation 256M(1), (2) or (4) is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment to a fine, to imprisonment for a term not exceeding two years, or to both.

(2) A person guilty of an offence under regulation 256M(3) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.]

PART 13U.K.Packaging and leaflets

CHAPTER 1U.K.

Requirements for packaging and package leaflets relating to medicinal productsU.K.

Packaging requirements: generalU.K.

257.—(1) The information specified in Part 1 of Schedule 24 must appear—

(a)on the outer packaging of a medicinal product; and

(b)on the immediate packaging of the product, unless paragraph (2) or (3) applies to the packaging.

(2) This paragraph applies to immediate packaging if the packaging is in the form of a blister pack and is placed in outer packaging which complies with the requirements of Part 1 of Schedule 24.

(3) This paragraph applies to immediate packaging if the packaging is too small to display the information required by Part 1 of Schedule 24.

(4) The information specified in Part 2 of Schedule 24 must appear on immediate packaging to which paragraph (2) applies.

(5) The information specified in Part 3 of Schedule 24 must appear on immediate packaging to which paragraph (3) applies.

(6) Information included on the packaging of a product in accordance with this regulation, [F1114regulation 257C F1115...,] regulation 261 and Schedule 24 must be easily legible, comprehensible and indelible.

(7) Nothing in this regulation or Schedule 24 applies to a registrable homoeopathic medicinal product.

[F1116(8) Nothing in this regulation applies to the outer or immediate packaging of an advanced therapy medicinal product F1117....]

[F1118(9) This regulation is subject to regulation 257AA.]

[F1119(10) Nothing in this regulation applies to a POC medicinal product that is the subject of a UKMA(UK)(Category 1).]

Textual Amendments

[F1120Packaging requirements: variation in accordance with regulation 68(11I)U.K.

257AA.—(1) This regulation applies where, in accordance with regulation 68(11I), the licensing authority thinks that a variation is necessary so that a UKMA(UK)(Category 2) is treated as a UKMA(GB) and separate UKMA(NI).

(2) Where this regulation applies, the licensing authority may require that, in relation to the UKMA(GB), the information specified in paragraph 18B of Schedule 24 is replaced with a statement that the medicinal product is for sale or supply in Great Britain only.

Textual Amendments

Transitional arrangementsU.K.

257AB.  The information specified in paragraph 18B of Schedule 24 is not required to appear on the packaging of a medicinal product released for sale or distribution before 1st January 2025, unless the product has been re-packaged or relabelled after that date.]

Textual Amendments

Packaging Requirements: medicinal products required to bear safety featuresU.K.

F1121257A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Transitional ArrangementsU.K.

F1122257B.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F1123Packaging requirements: advanced therapy medicinal productsU.K.

257C.—(1) The information specified in Part 4 of Schedule 24 must appear—

(a)on the outer packaging of an advanced therapy medicinal product F1124... (other than an exempt advanced therapy medicinal product); and

(b)on the immediate packaging of that product, unless paragraph (2) or (3) applies to the packaging.

(2) This paragraph applies to the immediate packaging if the packaging is in the form of a blister pack and is placed in outer packaging which complies with the requirements of Part 4 of Schedule 24.

(3) This paragraph applies to immediate packaging if the packaging is too small to display the information required by Part 4 of Schedule 24.

(4) The information specified in Part 5 of Schedule 24 must appear on immediate packaging to which paragraph (2) or (3) applies.

[F1125(5) Nothing in this regulation applies to an advanced therapy medicinal product that is a POC medicinal product, if the entirety of the product is to be administered immediately after manufacture.]

Textual Amendments

[F1126Packaging requirements: POC medicinal productsU.K.

257CA.—(1) This regulation applies to a POC medicinal product that is the subject of a UKMA(UK)(Category 1) and not—

(a)an advanced therapy medicinal product; and

(b)to be administered in its entirety immediately after manufacture.

(2) The information specified in Part 6 of Schedule 24 must appear—

(a)on the outer packaging of a POC medicinal product to which this regulation applies; and

(b)on the immediate packaging of that product, unless paragraph (3) or (4) applies to the packaging.

(3) This paragraph applies to the immediate packaging if the packaging is in the form of a blister pack and is placed in outer packaging which complies with the requirements of Part 6 of Schedule 24.

(4) This paragraph applies to the immediate packaging if the packaging is too small to display the information required by Part 6 of Schedule 24.

(5) The information specified in Part 7 of Schedule 24 must appear on the immediate packaging to which paragraph (3) or (4) applies.]

Textual Amendments

Guidance as to packaging and package leafletsU.K.

257D.—( 1) The licensing authority may publish guidance on packaging and package leaflets applicable to products for sale or supply in the whole United Kingdom or parts of the United Kingdom, as appropriate.

(2) Guidance published under paragraph (1) may, in particular, include—

(a)the wording of certain special warnings for certain categories of medicinal products;

(b)the particular information needs relating to products that are a pharmacy medicine;

(c)the legibility of particulars on the labelling and package leaflet;

(d)the methods of identification and authentication of medicinal products;

(e)the list of excipients which must feature on the labelling of medicinal products and the way in which these excipients must be indicated.

(3) Until such time as the licensing authority publishes guidance under paragraph (1), any guidance published by the Commission pursuant to Article 65 of the 2001 Directive, insofar as that guidance was in force immediately before IP completion day, continues to apply as if it had been published by the licensing authority under paragraph (1).

Textual Amendments

Regulation-making power as to certain forms of labellingU.K.

257E.  The Ministers may by regulations require the use of certain forms of labelling of a medicinal product in order to make it possible to ascertain—

(a)the price of the medicinal product;

(b)any reimbursement conditions of the National Health Service;

(c)the legal status for supply to the patient in accordance with regulation 5 (classification), insofar as not already provided for in Schedule 25;

F1127(d). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Textual Amendments

Packaging requirements: specific provisionsU.K.

258.—(1) In addition to other information required by this Part, the information specified in Part 1 of Schedule 25 must appear on the outer packaging, or, if there is no outer packaging, on the immediate packaging of a medicinal product sold or supplied in accordance with a prescription given by a person who is an appropriate practitioner for the purposes of regulation 214(3) to (6), whether or not the medicinal product in question is a prescription only medicine.

(2) The requirements of paragraph 4 or 6 of Schedule 25, as the case may be, are satisfied in relation to a package containing a number of packages of medicinal products of the same description if the information specified in paragraph 4 or 6 of that Schedule is shown on one or more of those packages.

(3) The information specified in Part 2 of that Schedule must appear on a package which contains a number of packages of medicinal products of the same description, other than special medicinal products, for the purpose of transport, delivery or storage.

(4) But paragraph (3) does not apply to a packing case, crate or other covering used solely for the purposes of transport or delivery of packages of medicinal products, each of which is labelled in accordance with the other requirements of this Part.

(5) In addition to the other information required by this Part, the information specified in Parts 3 and 4 of Schedule 25 must appear on the outer packaging and the immediate packaging of products of the kind specified in those Parts of that Schedule.

(6) Nothing in this regulation or Schedule 25 requires information to appear on—

(a)a package containing a medicinal product where part of the package is transparent or open, provided that the information required by this regulation and that Schedule is clearly visible through the transparent or open part of the package;

(b)a paper bag or similar wrapping in which a package that contains a medicinal product and bears information in accordance with the requirements of this regulation and that Schedule is placed at the time of sale or supply;

(c)a package enclosing a package of a medicinal product for export;

(d)an ampoule or other container of not more than 10 millilitres' nominal capacity which is enclosed in a package on which information appears in accordance with the requirements of this regulation and that Schedule; or

(e)a blister pack or similar packaging enclosed in a package on which information appears in accordance with the requirements of Parts 3 and 4 of Schedule 25.

(7) Nothing in this regulation or Schedule 25 applies to a medicinal product—

(a)which is an anti-viral medicine in the form of a solution to be used for the treatment of a child under the age of one year;

(b)on the container of which appears—

(i)the name of the person to whom the product is to be administered,

(ii)the date on which the product is sold or supplied, and

(iii)the necessary instructions for proper use; and

(c)which is sold or supplied for the purpose of treating a disease which is—

(i)a serious risk to human health, or potentially a serious risk to human health, and

(ii)pandemic or imminently pandemic.

(8) Nothing in this regulation or Schedule 25 applies to a traditional herbal medicinal product or a registrable homoeopathic medicinal product.

[F1128(9) Nothing in this regulation or Schedule 25 applies to a POC medicinal product.]

Textual Amendments

Packaging requirements: information for blind and partially sighted patientsU.K.

259.—(1) The name of a medicinal product must also be expressed in Braille format on the outer packaging of the product (or, if there is no outer packaging, on the immediate packaging of the product).

(2) The holder of a [F1129UK marketing authorisation, F1130...], Article 126a authorisation or traditional herbal registration for a medicinal product must ensure that the package leaflet is made available on request in formats suitable for blind and partially-sighted persons.

(3) Nothing in this regulation applies to a registrable homoeopathic medicinal product.

Textual Amendments

Package leafletsU.K.

260.—(1) A package leaflet for a medicinal product must—

(a)be drawn up in accordance with the summary of the product characteristics; and

(b)contain all the information specified in Schedule 27 in the order specified in that Schedule.

[F1131(1A) If the medicinal product is an advanced therapy medicinal product F1132... (other than an exempt advanced therapy medicinal product), the package leaflet must contain the information specified in Part 3 of Schedule 27 in the order specified in that Part.]

(2) A package leaflet must be included in the packaging of a medicinal product unless all the information required by Part 1 of Schedule 27 (and, where the product contains paracetamol, the information required by Part 2 of that Schedule) [F1133, or where the product is an advanced therapy medicinal product F1134..., the information specified in Part 3 of that Schedule,] is conveyed on the outer packaging or the immediate packaging of the product.

(3) A package leaflet relating to a medicinal product must be legible, clear and easy to use, and the applicant for, or holder of, a [F1135UK marketing authorisationF1136...,] Article 126a authorisation or traditional herbal registration relating to the product must ensure that target patient groups are consulted in order to achieve this.

(4) Regulation (5) applies in a case where a package leaflet is not provided under paragraph (2) because all the information required by Schedule 27 is conveyed on the outer packaging or the immediate packaging of the product.

(5) Where this paragraph applies, any requirement of these Regulations that is expressed by reference to a package leaflet shall be taken to refer to the outer packaging or, as the case may be, the immediate packaging of the product.

(6) Nothing in this regulation or Schedule 27 applies to a registrable homoeopathic medicinal product.

Textual Amendments

Use of pictures and symbols etcU.K.

261.—(1) The outer packaging and the package leaflet of a medicinal product may include—

(a)symbols, diagrams or pictures designed to clarify information mentioned in Part 1 of Schedule 24 or in Schedule 27; and

(b)other information, compatible with the summary of the product characteristics, which is useful to the patient.

(2) Symbols, diagrams, pictures or additional information included in accordance with this regulation must not include any element of a promotional nature.

(3) Nothing in this regulation applies to a registrable homoeopathic product.

Labelling requirements for radionuclidesU.K.

262.—(1) Where a medicinal product contains radionuclides—

(a)the carton and the container of the product must be labelled in accordance with the regulations for the safe transport of radioactive materials laid down by the International Atomic Energy Agency; and

(b)the labelling on the shielding and the vial must comply with the remaining provisions of this regulation.

(2) The label on the shielding must—

(a)include the information specified in Part 1 of Schedule 24;

(b)explain in full the codings used on the vial;

(c)indicate, where necessary, for a given time and date, the amount of radioactivity per dose or per vial; and

(d)indicate the number of capsules or, for liquids, the number of millilitres per container.

(3) The label on the vial must include—

(a)the name or code of the medicinal product, including the name or chemical symbol of the radionuclide;

(b)the batch identification and expiry date of the product;

(c)the international symbol for radioactivity;

(d)the name and address of the manufacturer; and

(e)the amount of radioactivity; as mentioned in paragraph 2(c).

Leaflets relating to radionuclidesU.K.

263.—(1) The licensing authority must ensure that a detailed instruction leaflet is enclosed with—

(a)radiopharmaceuticals;

(b)radionuclide generators;

(c)radionuclide kits; or

(d)radionuclide precursors.

(2) The leaflet must include the information specified in Schedule 27.

(3) The leaflet must also include—

(a)any precautions to be taken by the user and the patient during the preparation and administration of the medicinal product; and

(b)special precautions for the disposal of the packaging and its unused contents.

Homoeopathic medicinesU.K.

264.—(1) The outer packaging and immediate packaging and, where a package leaflet is included, the package leaflet of a homoeopathic medicinal product must clearly include the words “homoeopathic medicinal product”.

(2) The outer packaging and immediate packaging and, where a package leaflet is included, the package leaflet of a registrable homoeopathic medicinal product must also include the information specified in paragraph (1) and Part 1 of Schedule 28 and no other information (unless paragraph (5) or (6) applies).

(3) Regulation (4) applies in a case where a package leaflet is not included with a registrable homoeopathic medicinal product.

(4) Unless the context requires otherwise, any requirement of these Regulations that is expressed by reference to a package leaflet shall be taken to refer to—

(a)the outer packaging or the immediate packaging of the product; or

(b)in a case to which paragraph (5) or paragraph (6) applies, the outer packaging of the product.

(5) Where the immediate packaging of a registrable homoeopathic medicinal product is in the form of a blister pack and is placed in outer packaging which complies with the requirements of this regulation and Part 1 of Schedule 28, the immediate packaging must include the information specified in this regulation and Part 2 of Schedule 28.

(6) Where the immediate packaging of a registrable homoeopathic medicinal product is too small to display the information required by Part 1 of Schedule 28, the immediate packaging must include the information specified in this regulation and Part 3 of Schedule 28.

Additional requirements for traditional herbal medicinal productsU.K.

265.—(1) Schedule 29 imposes additional requirements in relation to traditional herbal medicinal products.

(2) Nothing in this regulation or Schedule 29 requires information to appear on—

(a)a package containing a traditional herbal medicinal product where part of the package is transparent or open, provided that the information required by this regulation and that Schedule is clearly visible through the transparent or open part of the package;

(b)a paper bag or similar wrapping in which a package that contains a traditional herbal medicinal product and bears information in accordance with the requirements of this regulation and that Schedule is placed at the time of sale or supply;

(c)a package enclosing a package of a traditional herbal medicinal product for export;

(d)an ampoule or other container of not more than 10 millilitres' nominal capacity which is enclosed in a package on which information appears in accordance with the requirements of this regulation and that Schedule; or

(e)a blister pack or similar packaging, enclosed in a package labelled in accordance with the requirements of this regulation and that Schedule.

Language requirements etcU.K.

266.—(1) Information given in accordance with the requirements of this Part must be given in English unless either or both of paragraphs (2) and (3) applies.

(2) This paragraph applies in the case of a medicinal product that has been designated as an orphan medicinal product under Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products M63 where—

(a)any information specified in paragraph (1) is given in a language of an EEA State other than English; and

(b)the licensing authority accedes to a reasoned request that the information need not be given in English.

(3) This paragraph applies in the case of a product for which the licensing authority grants an Article 126a authorisation where the licensing authority decides that the information need not be given in English.

(4) In a case where paragraph (5) applies, the licensing authority may grant either or both of—

(a)an exemption from the obligation that certain particulars should appear on the outer and immediate packaging and in the package leaflet of the medicinal product in accordance with this Part; and

(b)a full or partial exemption from the obligation that the information included on the outer and immediate packaging and in the package leaflet for the product must be given in English in accordance with paragraph (1).

(5) This paragraph applies—

(a)when a medicinal product is not intended to be delivered directly to the patient; or

(b)where there are severe problems in respect of the availability of the medicinal product.

(6) The licensing authority may make the grant of an exemption in accordance with paragraph (4) subject to measures that it considers necessary to safeguard human health

(7) Information given in English in accordance with this regulation may be given in several languages in addition to English, provided that the same particulars appear in all the languages used.

Marginal Citations

M63OJ No L 18, 22.1.2000, p.1, as amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p.14.

Submission of mock-ups of packaging and leaflets to licensing authorityU.K.

267.—(1) At the time when a person applies for a [F1137UK] marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration for a medicinal product, the person must submit to the licensing authority—

(a)one or more mock-ups of the outer packaging and immediate packaging proposed for the product; and

(b)a draft package leaflet.

(2) If the application is for a [F1137UK] marketing authorisation, Article 126a authorisation or traditional herbal registration, the person must also provide to the licensing authority the results of assessments of the packaging and package leaflet carried out in co-operation with target patient groups.

(3) The licensing authority must refuse the application for a [F1137UK] marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration if—

(a)the packaging or the package leaflet does not comply with the requirements of this Part; or

(b)(in relation to an application for a [F1137UK] marketing authorisation, Article 126a authorisation or traditional herbal registration) the information on the packaging or the package leaflet does not accord with the particulars listed in the summary of the product characteristics.

(4) If the holder of a [F1137UK] marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration for a product wishes to make changes to the packaging or the package leaflet (other than a change connected with the summary of the product characteristics), the proposed change must be submitted to the licensing authority in accordance with paragraph (5).

(5) In the circumstances in paragraph (4) the holder must submit to the licensing authority such of the following as are affected by the proposed change—

(a)one or more mock-ups of the outer packaging and immediate packaging of the product showing the proposed change; and

(b)a draft package leaflet showing the proposed change.

(6) If the licensing authority has not refused a proposed change within the period of 90 days beginning with the date of the submission, the applicant may make the change.

Textual Amendments

Enforcement and offencesU.K.

Offence relating to packaging and package leaflets [F1138in Great Britain]: holder of authorisation etcU.K.

268.—(1) This regulation applies to the holder of a [F1139UKMA(UK), UKMA(GB)], certificate of registration or traditional herbal registration for a medicinal product who sells or supplies, offers to sell or supply, or possesses for the purpose of sale or supply [F1140, in Northern Ireland], a medicinal product to which the authorisation, certificate or registration relates.

(2) A person to whom this regulation applies is guilty of an offence if—

(a)a package or package leaflet relating to the product does not comply with the applicable requirements of this Part F1141... or [F1142regulation 50C(4), 50D(8) or 58A(2)(b)]; or

(b)the product is not accompanied by a package leaflet when one is required by virtue of this Part.

Textual Amendments

[F1143Offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etcU.K.

268A.—(1) This regulation applies to the holder of a UKMA(UK), UKMA(NI), EU marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration for a medicinal product who sells or supplies, offers to sell or supply, or possesses for the purpose of sale or supply, in Northern Ireland, a medicinal product to which the authorisation, certificate or registration relates.

(2) A person to whom this regulation applies is guilty of an offence if—

(a)a package or package leaflet relating to the product does not comply with the applicable requirements of this Part F1144... or Article 28 or 32 of the Paediatric Regulation; or

(b)the product is not accompanied by a package leaflet when one is required by virtue of this Part.]

Textual Amendments

Offences relating to packaging and package leaflets [F1145in Great Britain]: other personsU.K.

269.—(1) This regulation applies to a person, other than the holder of a [F1146UKMA(UK), UKMA(GB)], certificate of registration or traditional herbal registration for a medicinal product, who, in the course of a business [F1147carried on by that person,] sells or supplies, or offers to sell or supply the product, or possesses the product for the purpose of sale or supply [F1148, in Great Britain].

(2) A person to whom this regulation applies is guilty of an offence if the person sells or supplies, or offers to sell or supply, the product, or possesses the product for the purpose of sale or supply, [F1149in Great Britain] knowing or having reasonable cause to believe—

(a)that a package or package leaflet relating to the medicinal product does not comply with the applicable requirements of this Part F1150... or [F1151regulation 50C(4), 50D(8) or 58A(2)(b)]; or

(b)that the product is not accompanied by a package leaflet when one is required by virtue of this Part.

Textual Amendments

F1147Words in reg. 269(1) inserted (E.W.S.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 7 and words in reg. 269(1) inserted (N.I.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 7

[F1152Offences relating to packaging and package leaflets in Northern Ireland: other personsU.K.

269A.—(1) This regulation applies to a person, other than the holder of a UKMA(UK), UKMA(NI) F1153..., Article 126a authorisation, certificate of registration or traditional herbal registration for a medicinal product, who, in the course of a business carried on by that person, sells or supplies, or offers to sell or supply the product, or possesses the product for the purpose of sale or supply in Northern Ireland.

(2) A person to whom this regulation applies is guilty of an offence if the person sells or supplies, or offers to sell or supply, the product, or possesses the product for the purpose of sale or supply, in Northern Ireland knowing or having reasonable cause to believe—

(a)that a package or package leaflet relating to the medicinal product does not comply with the applicable requirements of this Part F1154... or Article 28 or 32 of the Paediatric Regulation; or

(b)that the product is not accompanied by a package leaflet when one is required by virtue of this Part.]

Textual Amendments

Non-compliance with requirements of this PartU.K.

270.—(1) If the holder of a [F1155UK marketing authorisationF1156...,] Article 126a authorisation, certificate of registration or traditional herbal registration fails to comply with a requirement imposed by this Part in relation to a medicinal product, the licensing authority may give a notice to the holder requiring compliance within three months or such other period (which may be less than three months) as may be specified in the notice.

(2) If the holder fails to comply with the notice, the licensing authority may suspend the [F1157UK marketing authorisationF1158...,] Article 126a authorisation, certificate of registration or traditional herbal registration until the holder complies with the requirements of this Part.

(3) A person who fails to comply with a notice under this regulation is guilty of an offence.

Textual Amendments

Offences: penaltiesU.K.

271.  A person who is guilty of an offence under regulation [F1159268, 268A, 269, 269A] or 270 is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment, to a fine, to imprisonment for a term not exceeding two years, or to both.

Textual Amendments

CHAPTER 2U.K.

Requirements relating to child safetyU.K.

InterpretationU.K.

272.  In this Chapter—

“appropriate practitioner” means any of the persons described as appropriate practitioners in relation to any prescription only medicine in regulation 214(3), (5) and (6);

“regulated medicinal product” means a medicinal product containing aspirin, paracetamol or more than 24mg of elemental iron, in the form of tablets, capsules, pills, lozenges, pastilles, suppositories or oral liquids, but does not include—

(a)

effervescent tablets containing not more than 25% of aspirin or paracetamol by weight;

(b)

medicinal products in sachets or other sealed containers which hold only one dose;

(c)

medicinal products which are not intended for retail sale or for supply in circumstances corresponding to retail sale; or

(d)

medicinal products which are for export only.

Child resistant containers for regulated medicinal productsU.K.

273.—(1) Regulated medicinal products sold or supplied otherwise than in accordance with regulation 274 may be sold only in containers which are—

(a)opaque or dark tinted; and

(b)child resistant.

(2) For the purposes of these Regulations, containers which are not reclosable are child resistant if they have been evaluated in accordance with, and comply with the requirements of—

(a)British Standard EN 14375:2003 published by the British Standards Institution on 18th April 2005; or

[F1160(b)any specification for non-reclosable child resistant packaging that the licensing authority is satisfied is of an equivalent or higher technical specification to that specified in sub-paragraph (a).]

(3) For the purposes of these Regulations, containers which are reclosable are child resistant if they have been evaluated in accordance with, and comply with the requirements of—

(a)British Standard EN ISO 8317:2004 published by the British Standards Institution on 11th May 2005; or

[F1161(b)any specification for reclosable child resistant packaging that the licensing authority is satisfied is of an equivalent or higher technical specification to that specified in sub-paragraph (a).]

Textual Amendments

Exemptions from regulation 273U.K.

274.—(1) Regulation 273 does not apply to the retail sale, or supply in circumstances corresponding to retail sale, of regulated medicinal products in accordance with paragraph (2).

(2) Sale or supply is in accordance with this paragraph if the sale or supply is carried out—

(a)by or under the supervision of a pharmacist;

(b)[F1162at or from premises] which are a registered pharmacy; and

(c)either—

(i)in accordance with a prescription given by an appropriate practitioner where it is not reasonably practicable to provide the regulated medicinal products in containers that are both opaque or dark tinted and child resistant, or

(ii)at the request of a person who is aged 16 or over and specifically requests that the regulated medicinal products not be contained in a child resistant container.

(3) Regulation 273 also does not apply to the sale or supply of regulated medicinal products—

(a)by a doctor or dentist to a patient, or the patient's carer, for the patient's use;

(b)by a doctor or dentist to a person who is an appropriate practitioner, at the request of that person, for administration to a patient of that person; or

(c)in the course of the business of a hospital or health centre, where the sale or supply is for the purposes of administration, whether in the hospital or health centre or elsewhere, in accordance with the directions of an appropriate practitioner.

Textual Amendments

Colouring of aspirin and paracetamol products for childrenU.K.

275.  The sale or supply of a medicinal product containing aspirin or paracetamol of any colour other than white is prohibited if—

(a)it is a product for children aged 12 or under; and

(b)in the case of paracetamol, it is in a solid form (including tablets, capsules, pills, lozenges, pastilles or suppositories).

OffencesU.K.

276.—(1) A person is guilty of an offence if, in the course of a business, the person sells or supplies, or possesses for the purposes of sale or supply—

(a)a regulated medicinal product in a container which does not comply with the requirements of regulation 273, unless the sale or supply is or would be exempt from those requirements under regulation 274; or

(b)a medicinal product containing aspirin or paracetamol the sale or supply of which is prohibited under regulation 275.

(2) A person guilty of an offence under this regulation is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment to a fine, to imprisonment for a term not exceeding 2 years, or to both.

PART 14U.K.Advertising

CHAPTER 1U.K.General

InterpretationU.K.

277.—(1) In this Part—

“court” means the High Court or, in Scotland, the Court of Session;

[F1163“holder of a temporary authorisation” means, where there is in force in relation to a medicinal product an authorisation by the licensing authority on a temporary basis under regulation 174 (but not an authorisation, certificate or registration as mentioned in regulation [F1164281(1)(a) to (e)]), the person who is responsible for placing that product on the market in the United Kingdom;]

“injunction” (except in regulation 313) includes an interim injunction;

“OFCOM” means the Office of Communications;

“person qualified to prescribe or supply medicinal products” includes—

(a)

persons who, in the course of their profession or in the course of a business, may lawfully—

(i)

prescribe medicinal products,

(ii)

sell medicinal products by retail, or

(iii)

supply medicinal products in circumstances corresponding to retail sale; and

(b)

employees of such persons;

“publication”, in relation to an advertisement, means the dissemination or issue of that advertisement—

(a)

orally;

(b)

in writing;

(c)

by means of an electronic communications network within the meaning of the Communications Act 2003 M64; or

(d)

in any other way,

and includes causing or procuring such publication by or on behalf of another person, and “publish” has a corresponding meaning.

(2) In the application of this Part to Scotland—

(a)references to an injunction are to be read as references to an interdict; and

(b)references to an interim injunction are to be read as references to an interim interdict.

Textual Amendments

Marginal Citations

Functions of the MinistersU.K.

278.  A function of the Ministers under this Part may be exercised by either of them acting alone or both of them acting jointly (and references in this Part to “the Ministers” are to be read accordingly).

CHAPTER 2U.K.Requirements relating to advertising

GeneralU.K.

Products without a marketing authorisation etcU.K.

[F1165279.—(1) A person may not publish an advertisement in Great Britain for a medicinal product unless one of the following is in force for the product—

(a)a UKMA(GB) or UKMA(UK);

[F1166(aa)an authorisation by the licensing authority on a temporary basis under regulation 174;]

(b)a COR(GB) or COR(UK); or

(c)a THR(GB) or THR(UK).

(2) A person may not publish an advertisement in Northern Ireland for a medicinal product unless one of the following is in force for the product—

(a)a UKMA(NI) or UKMA(UK);

[F1167(aa)an authorisation by the licensing authority on a temporary basis under regulation 174;]

(b)a COR(NI) or COR(UK);

(c)a THR(NI) or THR(UK); [F1168or]

F1169(d). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(e)an Article 126a authorisation.

(3) A person may not publish an advertisement in the whole United Kingdom for a medicinal product unless, in relation to that product—

(a)one of the authorisations or registrations specified in paragraph (1) is in force in Great Britain; and

(b)one of the authorisations or registrations specified in paragraph (2) is in force in Northern Ireland.]

Textual Amendments

F1166Reg. 279(1)(aa) inserted (31.12.2020 immediately after S.I. 2019/775 comes into force) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(3), 11(a) and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350, regs. 1(3), 11(a)

General principlesU.K.

280.—(1) A person may not publish an advertisement for a medicinal product with a [F1170UK marketing authorisation F1171...,] traditional herbal registration or Article 126a authorisation unless the advertisement complies with the particulars listed in the summary of the product characteristics.

[F1172(1A) Where an advertisement mentioned in paragraph (1) relates to a product in relation to which there is a separate authorisation or registration in force in Great Britain and in Northern Ireland, it may not be published in the whole United Kingdom unless it complies with the particulars listed in the summary of the product characteristics in each of those authorisations or registrations (as the case may be).]

(2) A person may not publish an advertisement for a medicinal product unless the advertisement encourages the rational use of the product by presenting it objectively and without exaggerating its properties.

(3) A person may not publish an advertisement for a medicinal product that is misleading.

[F1173(4) A person may not publish an advertisement for a medicinal product in relation to which there is in force an authorisation by the licensing authority on a temporary basis under regulation 174 (but not an authorisation, certificate or registration as mentioned in regulation [F1174281(1)(a) to (e)]), unless it is published as part of a campaign that has been approved by the Ministers.]

Textual Amendments

Duties of authorisation holders and registration holdersU.K.

281.—(1) This regulation applies to a person who holds—

(a)a [F1175UK] marketing authorisation for a medicinal product;

(b)a certificate of registration for a medicinal product;

(c)a traditional herbal registration for a medicinal product; [F1176or]

(d)an Article 126a authorisation for a medicinal product ; F1177...

F1177(e). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F1178(1A) Paragraphs (3) to (5) apply to the holder of a temporary authorisation in relation to a medicinal product.]

(2) The person must establish a scientific service to compile and collate all information relating to the product (whether received from medical sales representatives employed by that person or from any other source).

(3) The person must ensure that any medical sales representative who promotes the product is given sufficient training, and has sufficient scientific knowledge, to enable the representative to provide information about the product that is as precise and complete as possible.

(4) The person must retain—

(a)a sample of any advertisement for which the person is responsible relating to the product; and

(b)a statement indicating the persons to whom the advertisement is addressed, the method of its publication and the date when it was first published.

(5) The person must, if required to do so by notice given to the person by the Ministers, within the period specified in that notice—

(a)provide a copy of the sample and statement mentioned in paragraph (4) to the Ministers;

(b)supply such other information as the Ministers may request for the purposes of their functions under this Part; or

(c)provide such assistance as the Ministers may request for those purposes.

Textual Amendments

Advertising to the publicU.K.

Application of regulations 283 to 292U.K.

282.  Regulations 283 (products for the purpose of inducing abortions) to 292 (exception for approved vaccination campaigns) apply to advertisements wholly or mainly directed at members of the public

Products for the purpose of inducing abortionsU.K.

283.  A person may not publish an advertisement that is likely to lead to the use of a medicinal product for the purpose of inducing an abortion.

Prescription only medicinesU.K.

284.—(1) A person may not publish an advertisement that is likely to lead to the use of a prescription only medicine.

(2) This regulation is subject to [F1179regulation 291A (campaigns relating to the suspected or confirmed spread of pathogenic agents etc.) and] regulation 292 (exception for approved vaccination campaigns).

Textual Amendments

[F1180Medicines with differing classification status in Great Britain and Northern IrelandU.K.

284A.  In the case of a medicinal product for sale or supply in Great Britain where the product concerned is not a prescription only medicine in Great Britain but is either—

(a)a prescription only medicine in Northern Ireland; or

(b)not authorised for sale or supply in Northern Ireland,

any advertisement to the public must include a statement that the medicinal product is not available without a prescription, or is not available for sale or supply, in Northern Ireland (as the case may be).]

Textual Amendments

Narcotic and psychotropic substancesU.K.

285.—(1) A person may not publish an advertisement relating to a medicinal product that—

(a)contains a substance which is listed in any of Schedules I, II or IV to the Narcotic Drugs Convention (where the product is not a preparation listed in Schedule III to that Convention); or

(b)contains a substance which is listed in any of Schedules I to IV to the Psychotropic Substances Convention (where the product is not a preparation which may be exempted from measures of control in accordance with paragraphs 2 and 3 of article 3 of that Convention).

(2) This regulation is subject to [F1181regulation 291A (campaigns relating to the suspected or confirmed spread of pathogenic agents etc.) and] regulation 292 (exception for approved vaccination campaigns).

Textual Amendments

Material relating to diagnosisU.K.

286.—(1) A person may not publish an advertisement relating to a medicinal product that states, or implies, that a medical consultation or surgical operation is unnecessary.

(2) A person may not, in particular, publish an advertisement relating to a medicinal product that offers to provide a diagnosis or suggest a treatment by post or by means of an electronic communications network within the meaning of the Communications Act 2003.

(3) A person may not publish an advertisement relating to a medicinal product that might, by a description or detailed representation of a case history, lead to erroneous self-diagnosis.

Material about effects of medicinal productU.K.

287.—(1) A person may not publish an advertisement relating to a medicinal product that suggests that the effects of taking the medicinal product—

(a)are guaranteed;

(b)are better than or equivalent to those of another identifiable treatment or medicinal product; or

(c)are not accompanied by any adverse reaction.

(2) A person may not publish an advertisement relating to a medicinal product that uses in terms that are misleading or likely to cause alarm pictorial representations of—

(a)changes in the human body caused by disease or injury; or

(b)the action of the medicinal product on the human body.

(3) A person may not publish an advertisement relating to a medicinal product that refers in terms that are misleading or likely to cause alarm to claims of recovery.

(4) A person may not publish an advertisement relating to a medicinal product that suggests that—

(a)the health of a person who is not suffering from any disease or injury could be enhanced by taking the medicinal product; or

(b)the health of a person could be affected by not taking the medicinal product.

(5) Paragraph (4)(b) is subject to [F1182regulation 291A (campaigns relating to the suspected or confirmed spread of pathogenic agents etc.) and] regulation 292 (exception for approved vaccination campaigns).

Textual Amendments

Material about status of medicinal productU.K.

288.  A person may not publish an advertisement relating to a medicinal product that suggests that—

(a)it is a foodstuff, cosmetic or other consumer product that is not a medicinal product; or

(b)its safety or efficacy is due to the fact that it is natural.

Recommendations by scientists etcU.K.

289.  A person may not publish an advertisement relating to a medicinal product that refers to a recommendation by—

(a)scientists;

(b)health care professionals; or

(c)persons who because of their celebrity could encourage use of the medicinal product.

Advertisements directed at childrenU.K.

290.  A person may not publish an advertisement relating to a medicinal product that contains any material that is directed principally at children.

Form and content of advertisementU.K.

291.—(1) A person may not publish an advertisement relating to a medicinal product unless it is presented so that—

(a)it is clear that it is an advertisement; and

(b)the product is clearly identified as a medicinal product.

(2) A person may not publish an advertisement relating to a medicinal product unless it includes—

(a)the name of the medicinal product;

(b)if the medicinal product contains only one active ingredient, the common name of the active ingredient;

(c)the information necessary for the correct use of the medicinal product; and

(d)an express and clear invitation to read carefully the instructions on the package or in the package leaflet (as the case may be).

(3) This regulation is subject to regulation 296 (exception for advertisements intended as a reminder).

(4) Paragraph (2) is subject to regulation 301 (advertisements for registered homoeopathic medicinal products).

[F1183(5) Paragraph (2)(d) is subject to regulation 291A (campaigns relating to the suspected or confirmed spread of pathogenic agents etc.).]

Textual Amendments

[F1184Campaigns relating to the suspected or confirmed spread of pathogenic agents etc.U.K.

291A.—(1) Regulations 284 (prescription only medicines), 285 (narcotic and psychotropic substances), 287(4)(b) (material about effects of a medicinal product) and 291(2)(d) (form and content of advertisement) do not apply to an advertisement as part of a campaign that—

(a)relates to the use of a medicinal product in response to the suspected or confirmed spread of—

(i)pathogenic agents,

(ii)toxins,

(iii)chemical agents, or

(iv)nuclear radiation; and

(b)has been approved by the Ministers.

(2) Before approving a campaign that relates to—

(a)all or any area of Scotland, the Ministers must consult the Scottish Ministers;

(b)all or any areas of Wales, the Ministers must consult the Welsh Ministers.]

Textual Amendments

Exception for approved vaccination campaignsU.K.

292.  Regulations 284 (prescription only medicines), 285 (narcotic and psychotropic substances) and 287(4)(b) (material about effects of medicinal products) do not apply to an advertisement as part of a vaccination campaign that—

(a)relates to a medicinal product that is a vaccine or serum; and

(b)has been approved by the Ministers.

Prohibition of supply to the public for promotional purposesU.K.

Prohibition of supply to the public for promotional purposesU.K.

293.—[F1185(1) The holder of [F1186either a temporary authorisation or]—

(a)in the case of a medicinal product for sale or supply in Great Britain, a UKMA(GB), UKMA(UK), COR(GB), COR(UK), THR(GB) or THR(UK); or

(b)in the case of a medicinal product for sale or supply in Northern Ireland, a UKMA(NI), UKMA(UK), COR(NI), COR(UK), THR(NI), THR(UK) F1187... or Article 126a authorisation,

may not sell or supply a medicinal product for a promotional purpose to a person who is not qualified to prescribe medicinal products.]

(2) A person who carries on a medicines business may not sell or supply a medicinal product for a promotional purpose to a person who is not qualified to prescribe medicinal products.

(3) This regulation applies regardless of whether the promotional purpose is that of the seller or supplier or of a third party.

(4) In this regulation “medicines business” means a business that consists in whole or in part of manufacturing, selling or supplying medicinal products.

Textual Amendments

Advertising to persons qualified to prescribe or supply etcU.K.

General requirementsU.K.

294.—(1) This regulation applies to an advertisement that—

(a)relates to a medicinal product; and

(b)is wholly or mainly directed at persons qualified to prescribe or supply such products.

(2) A person may not publish an advertisement to which this regulation applies unless—

(a)subject to [F1188paragraphs (2C) and (3),] it contains the particulars set out in paragraphs 1 to 8 of Schedule 30; and

(b)in the case of a written advertisement, it is in accordance with paragraph 9 of that Schedule.

[F1189(2A) By way of an exception to paragraph (2), in the case of an advertisement that relates to a pharmacy medicine or a medicinal product subject to general sale, a person may publish the advertisement if it contains—

(a)the particulars set out in paragraphs 2 to 6 of Schedule 30; and

(b)the statement “Information about this product, including adverse reactions, precautions, contra-indications, and method of use can be found at:”; accompanied by

(c)a website address that corresponds to that statement.

(2B) The website at the address mentioned in paragraph (2A)(c) must make available—

(a)the particulars set out in paragraphs 1 to 8 of Schedule 30; or

(b)a copy of the summary of the product characteristics.]

[F1190(2C) Paragraph 1 of Schedule 30 does not apply in the case of a product in relation to which there is in force an authorisation by the licensing authority on a temporary basis under regulation 174.]

(3) In the case of an advertisement that is not a written advertisement, those particulars may alternatively be made available in written form to all persons to whom the advertisement is made available.

(4) This regulation—

(a)does not apply to an advertisement to which regulation 295 (abbreviated advertisements) applies;

(b)does not apply to oral representations made by medical sales representatives to which regulation 299 (medical sales representatives) applies; and

(c)is subject to regulations 296 (exception for advertisements intended as a reminder) and 301 (advertisements for registered homoeopathic medicinal products).

[F1191(5) In the case of an advertisement which relates to a medicinal product for sale or supply—

(a)in Northern Ireland only, the requirements of this regulation must be met in relation to the product for sale or supply in Northern Ireland,

(b)in Great Britain only, the requirements of this regulation must be met in relation to the product for sale or supply in Great Britain, and

(c)in the whole of the United Kingdom, the requirements of this regulation must be met in relation to both—

(i)the product for sale or supply in Great Britain, and

(ii)the product for sale or supply in Northern Ireland.]

Textual Amendments

Abbreviated advertisementsU.K.

295.—(1) This regulation applies to an abbreviated advertisement that—

(a)relates to a medicinal product; and

(b)is wholly or mainly directed at persons qualified to prescribe or supply such products.

(2) A person may not issue an abbreviated advertisement to which this regulation applies unless it contains—

(a)the particulars set out in paragraphs 2 to 6 of Schedule 30 (particulars for advertisements to persons qualified to prescribe or supply);

(b)the statement “Information about this product, including adverse reactions, precautions, contra-indications, and method of use can be found at:”; accompanied by

(c)a web site address that corresponds to that statement; and

[F1192(d)the name and address of the holder [F1193of either the temporary authorisation or]—

(i)in the case of a medicinal product for sale or supply in Great Britain, of the UKMA(GB), UKMA(UK), COR(GB), COR(UK), THR(GB) or THR(UK) for the medicinal product, or

(ii)in the case of a medicinal product for sale or supply in Northern Ireland, the name and address of the holder of the UKMA(NI), UKMA(UK), COR(NI), COR(UK), THR(NI), THR(UK) F1194... or Article 126a authorisation for the medicinal product,

or the business name and address of the part of the holder's business that is responsible for the sale or supply of the medicinal product.]

(3) The web site at the address mentioned in sub-paragraph (2)(c) must make available—

(a)the particulars set out in Schedule 30; or

(b)a copy of the summary of the product characteristics.

(4) In this regulation, “abbreviated advertisement” means an advertisement, other than a loose insert, that—

(a)does not exceed 420 square centimetres in size; and

(b)appears in a publication sent or delivered wholly or mainly to persons qualified to prescribe or supply medicinal products.

[F1195(4A) In the application of this regulation to a medicinal product for sale or supply—

(a)in Northern Ireland only, the requirements of this regulation must be met in relation to the product for sale or supply in Northern Ireland,

(b)in Great Britain only, the requirements of this regulation must be met in relation to the product for sale or supply in Great Britain, and

(c)in the whole of the United Kingdom, the requirements of this regulation must be met in relation to both—

(i)the product for sale or supply in Great Britain, and

(ii)the product for sale or supply in Northern Ireland.]

(5) This regulation is subject to regulation 301 (advertisements for registered homoeopathic medicinal products).

Textual Amendments

Exception for advertisements intended as a reminderU.K.

296.  Regulations 291 (form and content of advertisement) and 294 (general requirements) do not apply to an advertisement relating to a medicinal product if the advertisement is intended solely as a reminder of the product and consists solely of—

(a)in the case of a product other than a homoeopathic medicinal product to which a certificate of registration relates, its name, international non-proprietary name or trademark; and

(b)in the case of a homoeopathic medicinal product to which a certificate of registration relates, its name, international non-proprietary name, invented name or trademark or the scientific name of the stock or stocks from which it is derived.

Written material accompanying promotionsU.K.

297.—(1) A person may not as part of the promotion of a medicinal product send or deliver any written material to a person qualified to prescribe or supply medicinal products unless the material—

(a)[F1196subject to paragraph (1A),] contains particulars in accordance with all the paragraphs of Schedule 30; and

(b)states the date on which it was drawn up or last revised.

[F1197(1A) Paragraph 1 of Schedule 30 does not apply in the case of a product in relation to which there is in force an authorisation by the licensing authority on a temporary basis under regulation 174.]

(2) A person may not include any information in written material to which paragraph (1) applies unless it—

(a)is accurate;

(b)is up-to-date;

(c)can be verified; and

(d)is sufficiently complete to enable the recipient to form an opinion of the therapeutic value of the product to which it relates.

(3) A person may not include any illustrative material in written material to which paragraph (1) applies unless—

(a)the illustrative material is accurately reproduced; and

(b)the written material indicates the precise source of the illustrative material.

(4) In this regulation “illustrative material” means a quotation, table or any other illustrative material taken from a medical journal or other scientific work.

Textual Amendments

Free samples for persons qualified to prescribe or supply medicinal productsU.K.

298.—(1) A person (“the supplier”) may not supply a free sample of a medicinal product to another person (“the recipient”) unless the following conditions are met.

(2) Condition A is that the recipient—

(a)is qualified to prescribe medicinal products; and

(b)receives the sample for the purpose of acquiring experience in dealing with the product in question.

(3) Condition B is that the sample is supplied to the recipient—

(a)on an exceptional basis; and

(b)in response to a request from, and signed and dated by, the recipient.

(4) Condition C is that, taking the year in which the sample is supplied as a whole, only a limited number of samples of the product in question are supplied to the recipient in that year.

(5) Condition D is that the sample—

[F1198(a)is no larger than the smallest presentation of the product that is available for sale—

(i)in the case of a medicinal product for sale or supply in Great Britain, in Great Britain, or

(ii)in the case of a medicinal product for sale or supply in Northern Ireland, in Northern Ireland;]

(b)is marked “free medical sample – not for resale” or bears a similar description; and

(c)is accompanied by a copy of the summary of the product characteristics.

(6) Condition E is that the sample does not contain—

(a)a substance which is listed in any of Schedules I, II or IV to the Narcotic Drugs Convention (where the product is not a preparation listed in Schedule III to that Convention); or

(b)a substance which is listed in any of Schedules I to IV to the Psychotropic Substances Convention (where the product is not a preparation which may be exempted from measures of control in accordance with paragraphs 2 and 3 of article 3 of that Convention).

(7) Condition F is that the supplier maintains an adequate system of control and accountability in relation to the supply of free samples.

Textual Amendments

Medical sales representativesU.K.

299.—(1) This regulation applies in relation to the promotion by a medical sales representative of medicinal products to persons qualified to prescribe or supply such products.

(2) During each visit for promotional purposes the representative must give to, or have available for, each person visited a copy of the summary of the product characteristics for each product promoted.

(3) The representative must report all information, with particular reference to any adverse reactions, that—

(a)is received from persons visited for promotional purposes; and

(b)relates to the use of a product promoted,

to the scientific service established in accordance with regulation 281(2) by the holder of the [F1199UK marketing authorisation, F1200...] certificate of registration, traditional herbal registration or Article 126a authorisation for the product.

Textual Amendments

Inducements and hospitalityU.K.

300.—(1) A person may not, in connection with the promotion of medicinal products to persons qualified to prescribe or supply them, supply, offer, or promise any gift, pecuniary advantage or benefit unless it is—

(a)inexpensive; and

(b)relevant to the practice of medicine or pharmacy.

(2) A person may not provide hospitality at a meeting or event held for the purposes of the promotion of a medicinal product unless—

(a)the hospitality is strictly limited to the main purposes of the meeting or event; and

(b)the person to whom it is provided or offered is a health care professional.

(3) Nothing in this regulation shall prevent any person providing hospitality at an event held for purely professional or scientific purposes provided that—

(a)the hospitality is strictly limited to the main scientific objective of the event; and

(b)the person to whom it is provided or offered is a health care professional.

(4) A person qualified to prescribe or supply medicinal products may not solicit or accept any gift, pecuniary advantage, benefit or hospitality that is prohibited by this regulation.

(5) In this regulation “hospitality” includes—

(a)sponsorship of a person's attendance at a meeting or event; and

(b)the payment of travelling or accommodation expenses.

(6) This regulation does not apply in relation to measures or trade practices relating to prices, margins or discounts that were in existence on 1st January 1993.

Homoeopathic medicinal productsU.K.

Advertisements for registered homoeopathic medicinal productsU.K.

301.—(1) A person may not publish an advertisement relating to a homoeopathic medicinal product to which a certificate of registration relates unless the advertisement meets the following conditions.

(2) Condition A is that the advertisement does not mention any specific therapeutic indications.

(3) Condition B is that the advertisement does not contain any details other than those mentioned in Schedule 28 (labelling requirements for registrable homoeopathic medicinal products).

(4) Nothing in regulation 291(2) (form and content of advertisement), 294 (general requirements) or 295 (abbreviated advertisements) requires an advertisement relating to a homoeopathic medicinal product to which a certificate of registration relates to contain any detail not specified in Schedule 28.

Traditional herbal medicinal productsU.K.

Advertisements for traditional herbal medicinal productsU.K.

302.  A person may not publish an advertisement relating to a herbal medicinal product to which a traditional herbal registration relates unless it contains—

(a)the words “Traditional herbal medicinal product for use in”; followed by

(b)a statement of one or more therapeutic indications for the product consistent with the terms of the registration; followed by

(c)the words “exclusively based on long standing use”.

OffencesU.K.

OffencesU.K.

303.—(1) A person is guilty of an offence if that person commits a breach of a provision in this Chapter.

(2) A breach of a provision in this Chapter includes any—

(a)contravention by any person of any prohibition in this Chapter; and

(b)failure by any person to comply with any requirement or obligation in this Chapter.

(3) A person guilty of an offence under this regulation other than one to which paragraph (4) applies is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment to a fine, to imprisonment for a term not exceeding two years or to both.

(4) This paragraph applies to an offence consisting of a breach of—

(a)regulation 298(1) (free samples);

(b)regulation 299(2) or (3) (medical sales representatives); or

(c)regulation 300(4) (solicitation or acceptance of inducements or hospitality).

(5) A person guilty of an offence to which paragraph (4) applies is liable on summary conviction to a fine not exceeding level 5 on the standard scale.

CHAPTER 3U.K.Monitoring of Advertising

Scrutiny by MinistersU.K.

Requirement to provide copy advertisementU.K.

304.—(1) The Ministers may give a notice in writing under paragraph (2) or (3) to any person appearing to them to be concerned or likely to be concerned with the publication of advertisements relating to medicinal products.

(2) A notice under this paragraph is a notice that requires the person to whom it is given to provide the Ministers within a specified period with a copy of any advertisement that, as at the date of service of the notice, the person has published or proposes to publish and that relates to—

(a)a specified medicinal product; or

(b)medicinal products of a specified class or description.

(3) A notice under this paragraph is a notice that requires the person to whom it is given to provide the Ministers with a copy of any advertisement that the person proposes to publish during a specified period and that relates to—

(a)a specified medicinal product; or

(b)medicinal products of a specified class or description.

(4) The period specified in a notice under paragraph (3) must not exceed 12 months.

(5) A notice under paragraph (3) must specify the number of days before the proposed publication date of any advertisement by which a copy of the advertisement must be provided to the Ministers.

(6) A notice under paragraph (3) may be withdrawn by the Ministers before the expiry of the specified period.

(7) A notice under paragraph (2) or (3) may require the person to whom it is given not to publish, or further publish, during a specified period any advertisement a copy of which the person is required by the notice to provide to the Ministers.

(8) A notice under paragraph (2) or (3) must give the Ministers' reasons for giving the notice and (if appropriate) for imposing a requirement under paragraph (7).

(9) In this regulation “specified” means specified in the notice.

Invitation to make representations about compatibilityU.K.

305.—(1) This regulation applies if, having considered an advertisement a copy of which is obtained by them pursuant to a notice given under regulation 304 or by some other means, the Ministers are minded to make a determination under regulation 306 that the advertisement is incompatible with the prohibitions imposed by Chapter 2.

(2) The Ministers may give a notice in writing under this regulation to any person appearing to them to be concerned or likely to be concerned with the publication of the advertisement.

(3) A notice under this regulation must—

[F1201(a)state that the Ministers are minded to make a determination under regulation 306 that the advertisement is incompatible with the prohibitions imposed by Chapter 2 and specify whether the incompatibility is insofar as the advertisement is for publication—

(i)in Great Britain;

(ii)in Northern Ireland; or

(iii)in both Great Britain and Northern Ireland;]

(b)give the reasons why they are minded to make the determination;

(c)state that the person to whom it is given may make written representations to the Ministers within the period of 21 days beginning immediately after the date of the notice as to why the advertisement is compatible with the prohibitions imposed by Chapter 2; and

(d)refer to the action that may be taken by the Ministers under regulation 306.

(4) A notice under this regulation may require the person to whom it is given not to publish, or to cease to publish, the advertisement

[F1202(a)in Great Britain;

(b)in Northern Ireland; or

(c)in both Great Britain and Northern Ireland].

Textual Amendments

Decision about compatibilityU.K.

306.—(1) This regulation applies if the Ministers have given a notice under regulation 305 (“the original notice”) to a person.

(2) After the end of the period of 21 days referred to in that regulation, the Ministers must give a further notice in writing (“the new notice”) to that person of their determination whether the advertisement is compatible with the prohibitions imposed by Chapter 2 [F1203and specify whether the incompatibility is insofar as the advertisement is for publication—

(a)in Great Britain;

(b)in Northern Ireland; or

(c)in both Great Britain and Northern Ireland].

(3) In making that determination, the Ministers must take account of any representations made in accordance with that regulation.

(4) If—

(a)the Ministers make a determination that the advertisement is compatible with the prohibitions imposed by Chapter 2 [F1204insofar as the advertisement is for publication—

(i)in Great Britain;

(ii)in Northern Ireland; or

(iii)in both Great Britain and Northern Ireland]; and

(b)the original notice imposed a requirement under regulation 305(4),

the new notice must provide that the requirement no longer applies [F1205 in Great Britain, Northern Ireland, or both Great Britain and Northern Ireland (as appropriate)].

(5) The following provisions apply if the Ministers make a determination that the advertisement is incompatible with the prohibitions imposed by Chapter 2 [F1206insofar as the advertisement is for publication—

(a)in Great Britain;

(b)in Northern Ireland; or

(c)in both Great Britain and Northern Ireland].

(6) The new notice must give the Ministers' reasons for the determination.

(7) If the original notice imposed a requirement under regulation 305(4), the new notice may provide—

(a)that the requirement is to continue to apply; or

(b)that the requirement no longer applies [F1207,

and where that original notice related to both Great Britain and Northern Ireland, the new notice may be expressed to apply in relation to either of or both Great Britain and Northern Ireland].

(8) If the original notice did not impose a requirement under regulation 305(4), the new notice may require the person to whom it is given not to publish, or to cease to publish, the advertisement

[F1208(a)in Great Britain;

(b)in Northern Ireland; or

(c)in both Great Britain and Northern Ireland].

Textual Amendments

Corrective statementU.K.

307.—(1) This regulation applies if the new notice—

(a)maintains the application of a requirement imposed under regulation 305(4) to cease to publish the advertisement that is the subject of the notice [F1209in—

(i)Great Britain;

(ii)Northern Ireland; or

(iii)both Great Britain and Northern Ireland]; or

(b)imposes a requirement to cease to publish that advertisement [F1210in—

(i)Great Britain;

(ii)Northern Ireland; or

(iii)both Great Britain and Northern Ireland].

(2) The new notice may require the person to whom it is given to publish—

(a)the Ministers' reasons for making the determination that the advertisement was incompatible with the prohibitions imposed by Chapter 2 [F1211in respect of—

(i)Great Britain;

(ii)Northern Ireland; or

(iii)both Great Britain and Northern Ireland,

either in full or in part; and]

(b)a corrective statement concerning the advertisement.

(3) A requirement imposed under paragraph (2)—

(a)must specify the time within which publication must take place; and

(b)may specify the form of publication.

Textual Amendments

F1211Reg. 307(2)(a)(i)-(iii) and words substituted for words (31.12.2020) by S.I. 2019/775, reg. 217C(c) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)

OffencesU.K.

308.—(1) A person is guilty of an offence if that person fails to comply with a requirement imposed by a notice given to that person under—

(a)regulation 304(2) or (3);

(b)regulation 305(4) (including such a notice as maintained under regulation 306(7)); or

(c)regulation 306(8).

(2) A person guilty of an offence under paragraph (1) is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment to a fine, to imprisonment for a term not exceeding two years or to both.

(3) A person is guilty of an offence if that person fails to comply with a requirement imposed on that person under regulation 307(2).

(4) A person guilty of an offence under paragraph (3) is liable on summary conviction to a fine not exceeding level 5 on the standard scale.

Complaints to MinistersU.K.

Complaints to Ministers: duty to considerU.K.

309.—(1) This regulation applies if a person makes a complaint to the Ministers that an advertisement that has been published, or that is proposed to be published, is incompatible with the prohibitions imposed by Chapter 2.

(2) Subject to the following provisions of this regulation and to regulation 310, the Ministers must consider the complaint unless it appears to the Ministers to be frivolous or vexatious.

(3) The Ministers are not under any duty to consider a complaint if either OFCOM or a body that appears to the Ministers to be a self-regulatory body that deals with complaints about advertisements of the type in question is already dealing with the same complaint.

(4) If the Ministers have served a notice in respect of the advertisement under regulation 305 (whether or not they have taken action in respect of it under regulation 306) they—

(a)may consider the complaint; but

(b)are not under any duty to do so.

(5) If the complaint is one that OFCOM would be under a duty to consider if it had been made to OFCOM (see regulation 314) the Ministers must—

(a)investigate the complaint; or

(b)seek the agreement of the complainant to the complaint being referred to OFCOM.

(6) If, within a reasonable time of being approached by the Ministers, the complainant agrees to the complaint being referred to OFCOM the Ministers must refer the complaint to OFCOM.

(7) If, within a reasonable time of being approached by the Ministers, the complainant does not agree to the referral of the complaint, the Ministers must consider the complaint.

(8) The Ministers must also consider the complaint if, having referred it to OFCOM, OFCOM—

(a)decides not to consider the complaint because it appears to OFCOM to be frivolous or vexatious; or

(b)fails to deal adequately with the complaint within a reasonable time of the referral being made.

Complaints to Ministers: power to referU.K.

310.—(1) This regulation applies if—

(a)a person (“the complainant”) makes a complaint within paragraph (2) to the Ministers that an advertisement that has been published, or that it is proposed be published, is incompatible with the prohibitions imposed by Chapter 2; and

(b)the complaint does not appear to the Ministers to be frivolous or vexatious.

(2) A complaint is within this paragraph if—

(a)it is a complaint that the advertisement contains material prohibited by any of regulations 286 to 290, but is not a complaint that OFCOM would be under a duty to consider if it had been made to OFCOM (see regulation 314); or

(b)it is a complaint that the advertisement is incompatible with any of the prohibitions imposed by regulations 294 to 300.

(3) The Ministers may—

(a)select a body that appears to them to be a self-regulatory body that deals with complaints about advertisements of the type in question (“the appropriate body”); and

(b)seek the agreement of the complainant to the complaint being referred to the appropriate body.

(4) If within a reasonable time of being approached by the Ministers the complainant agrees to the complaint being referred to the appropriate body, the Ministers must refer the complaint to that body.

(5) If within a reasonable time of being approached by the Ministers the complainant does not agree to the referral of the complaint, the Ministers must consider the complaint.

(6) The Ministers must also consider the complaint if, having referred it to the appropriate body—

(a)the appropriate body decides not to consider the complaint because it appears to the body to be frivolous or vexatious; or

(b)the Ministers think that the appropriate body has failed to deal adequately with the complaint within a reasonable time of the referral being made.

(7) But if the Ministers have served a notice in respect of the advertisement under regulation 305 (whether or not they have taken action in respect of it under regulation 306)—

(a)the duties in paragraphs (4) to (6) do not apply; and

(b)each of those paragraphs has effect as if it conferred a power on the Ministers to act as mentioned in that paragraph.

InjunctionsU.K.

Application for injunctionU.K.

311.—(1) This regulation applies—

(a)if the Ministers consider that an advertisement that has been published, or that is proposed to be published, is incompatible with the prohibitions imposed by [F1212Chapter 2 in respect of—

(i)Great Britain;

(ii)Northern Ireland; or

(iii)both Great Britain and Northern Ireland; and]

(b)whether or not a complaint has been made to the Ministers or to any other person.

(2) The Ministers may apply to the court for an injunction against any person appearing to them to be concerned or likely to be concerned with the publication of the advertisement.

(3) On the making of an application under paragraph (2), the court may grant an injunction prohibiting the publication, or further publication, of the advertisement [F1213in—

(i)Great Britain;

(ii)Northern Ireland; or

(iii)both Great Britain and Northern Ireland,

as the case may be.]

(4) An injunction granted under paragraph (3) may also prohibit the publication, or further publication, of any advertisement in similar terms or likely to convey a similar impression.

(5) The court may not refuse to grant an injunction for lack of evidence that—

(a)the publication, or proposed publication, of the advertisement has given rise to loss or damage to any person; or

(b)the person responsible for the advertisement intended it to be incompatible with the prohibitions imposed by Chapter 2 or failed to exercise proper care to prevent it from being so incompatible.

(6) The court must give its detailed reasons in writing for its decision to grant or refuse an injunction.

(7) Where the court grants an injunction, the Ministers must as soon as is reasonably practicable provide the following in writing to each person against whom the injunction has been granted—

(a)the court's reasons for granting the injunction;

(b)any remedy available in the court; and

(c)the time limit to be met for any remedy to be available.

Textual Amendments

F1212Reg. 311(1)(a)(i)-(iii) substituted for words in reg. 311(1)(a) (31.12.2020) by S.I. 2019/775, reg. 217D(a) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)

Application for injunction: accuracy of factual claimU.K.

312.—(1) This regulation applies if—

(a)an application for an injunction is made under regulation 311; and

(b)the advertisement in question makes a factual claim about the medicinal product to which it relates.

(2) The court may require any person appearing to it to be responsible for the advertisement to provide evidence as to the accuracy of the factual claim.

(3) The court may impose a requirement under paragraph (2)—

(a)on the application of any party to the proceedings for the injunction; or

(b)of its own motion.

(4) In deciding whether or not to impose a requirement under paragraph (2) the court must have regard to the interests of any person who would be subject to, or affected by, the requirement.

(5) A requirement imposed under paragraph (2) must specify the time within which the evidence must be provided.

(6) If the person on whom a requirement is imposed under paragraph (2) fails to comply with it the court may infer that the factual claim is inaccurate.

(7) A person may fail to comply with a requirement imposed under paragraph (2) by—

(a)not providing any evidence; or

(b)providing evidence that the court considers inadequate.

Grant of injunction: publication of decision and corrective statementU.K.

313.—(1) This regulation applies if the court grants an injunction under regulation 311, other than an interim injunction, in respect of an advertisement that has been published.

(2) The Ministers may by notice in writing require any person against whom the injunction has been granted to publish—

(a)all or part of the court's decision; and

(b)a corrective statement concerning the advertisement in respect of which the application for the injunction was made.

(3) A requirement imposed under paragraph (2)—

(a)must specify the time within which publication must take place; and

(b)may specify the form of publication.

(4) If a person (“P”) fails to comply with a requirement imposed under paragraph (2) the Ministers may certify that failure to the court and the court may enquire into the matter.

(5) If the court enquires into the matter it must as part of its enquiry—

(a)hear any witnesses produced against or on behalf of P; and

(b)consider any statement offered in P's defence.

(6) If having conducted its enquiry the court is satisfied that P failed without reasonable excuse to comply with a requirement imposed under paragraph (2) it may deal with P as if P were in contempt of court.

Complaints to OFCOMU.K.

Complaints to OFCOMU.K.

314.—(1) This regulation applies if OFCOM—

(a)receives from a person a complaint that an advertisement that contains material prohibited by any of regulations 286 to 290 (“prohibited material”) has been included in—

(i)a licensed service, or

(ii)S4C Digital or a service provided by the Welsh Authority under section 205 of the Communications Act 2003 M65 (“the 2003 Act”); or

(b)has a complaint as described in sub-paragraph (a) referred to it by the Ministers under regulation 309(5) and (6).

(2) OFCOM must consider the complaint unless—

(a)the complaint appears to it to be frivolous or vexatious; or

(b)paragraph (3) applies.

(3) If the Ministers have served a notice in respect of the advertisement under regulation 305 (whether or not they have taken action in respect of it under regulation 306) OFCOM—

(a)may consider the complaint; but

(b)is not subject to any duty to do so.

(4) If, having considered the complaint, OFCOM considers that the advertisement contains prohibited material it may—

(a)in the case of an advertisement that has been included in a licensed service, give to the person who is the holder of the licence in respect of that service a direction to exclude the advertisement from the licensed service; and

(b)in the case of an advertisement that has been included in S4C Digital or a service provided by the Welsh Authority under section 205 of the 2003 Act, give to the Welsh Authority a direction to exclude the advertisement from S4C Digital or the service provided under section 205 of the 2003 Act.

(5) If OFCOM gives a direction under paragraph (4), it may also give a direction to the licence holder or (as the case may be) the Welsh Authority to exclude from the service any advertisement in similar terms or likely to convey a similar impression.

(6) In deciding whether or not to exercise its power to give a direction under paragraph (4), OFCOM must disregard any lack of evidence that—

(a)the publication of the advertisement has given rise to loss or damage to any person; or

(b)the person responsible for the advertisement intended it to be incompatible with the prohibitions imposed by Chapter 2 or failed to exercise proper care to prevent it from being so incompatible.

(7) A direction given under this regulation to a licence holder is to be treated for the purposes of the 2003 Act as a direction with respect to a matter mentioned in section 325(5) of that Act.

(8) A direction given under this regulation to the Welsh Authority is to be treated for the purposes of the Communications Act 2003 Act as a direction with respect to a matter mentioned in paragraph 14(2) of Schedule 12 to that Act.

(9) If OFCOM gives a direction under this regulation, it must inform the licence holder or (as the case may be) the Welsh Authority in writing of its reasons for doing so.

(10) In this regulation—

“licensed service” means a service in respect of which OFCOM has granted a licence under Part 1 or 3 of the Broadcasting Act 1990 M66 or Part 1 or 2 of the Broadcasting Act 1996 M67;

“S4C Digital” means the television service provided in digital form and known as S4C Digital; and

“Welsh Authority” means the authority whose name is, by virtue of section 56(1) of the Broadcasting Act 1990 M68, Sianel Pedwar Cymru.

Marginal Citations

M68Section 56(1) was amended by section 406(7) of and Schedule 19(1) to the Communications Act 2003.

GeneralU.K.

Public interest etcU.K.

315.  In exercising the functions conferred on them by this Chapter, the Ministers, the court and OFCOM must have regard, in particular, to the public interest.

Civil proceedingsU.K.

316.  In exercising the functions conferred on them by this Chapter, the Ministers may institute civil proceedings in their own name.

PART 15U.K.British Pharmacopoeia

British Pharmacopoeia and compendiaU.K.

317.—(1) The British Pharmacopoeia Commission (in this Part referred to as “the BPC”) must, at such intervals as it thinks appropriate, prepare or cause to be prepared editions of the British Pharmacopoeia, containing such relevant information relating to substances, combinations of substances and articles falling within paragraph (2) as the BPC thinks appropriate.

(2) The substances, combinations of substances, and articles falling within this paragraph are—

(a)substances, combinations of substances and articles (whether medicinal products or not) which are or may be used in the practice of medicine or surgery (other than veterinary medicine or veterinary surgery), dentistry or midwifery; and

(b)substances, combinations of substances and articles used in the manufacture of anything falling within paragraph (a).

(3) The BPC may also, at such intervals as it thinks appropriate, prepare or cause to be prepared—

(a)a compendium (other than the British Pharmacopoeia) containing such relevant information relating to substances, combinations of substances and articles within paragraph (2) as the BPC thinks appropriate; and

(b)a compendium containing such relevant information as the BPC thinks appropriate in relation to—

(i)substances, combinations of substances and articles (whether veterinary medicinal products or not) which are or may be used in the practice of veterinary medicine or veterinary surgery; and

(ii)substances, combinations of substances and articles used in the manufacture of anything falling within sub-paragraph (i).

(4) The Ministers must arrange for the publication of anything prepared or caused to be prepared by the BPC under this regulation.

(5) In this Part—

(a)a reference to preparing a thing or causing it to be prepared includes amending it, or causing it to be amended;

(b)a reference to publication includes publication by electronic means; and

(c)“relevant information”, in relation to a substance, combination of substances or article, means information consisting of descriptions of, standards for, or notes or other matter relating to the substance, combination of substances or article.

Lists of namesU.K.

318.—(1) The BPC must, at such intervals as it thinks appropriate, prepare or cause to be prepared a list of names which appear to it to be suitable—

(a)to be used as the names of substances, combinations of substances or articles falling within regulation 317(2) or (3)(b); and

(b)to be placed at the head of monographs relating to those substances, combinations of substances or articles in any edition of the British Pharmacopoeia or in a compendium prepared under that regulation.

(2) Where a list has been prepared in accordance with paragraph (1), the Ministers must cause it to be published.

Other documentsU.K.

319.—(1) The BPC must, at such intervals as it thinks appropriate, prepare or cause to be prepared other documents (in addition to those falling within regulation 317 or 318) containing such relevant information relating to substances, combinations of substances or articles falling within regulation 317(2) or (3)(b) as the BPC thinks appropriate.

(2) Where a document has been prepared in accordance with paragraph (1), the Ministers may cause it to be published.

Supplementary provisionsU.K.

320.—(1) Anything published in accordance with a provision of this Part (other than regulation 319 (“a publication”) must specify the date on which it is to take effect.

(2) The Ministers must give notice of the date mentioned in paragraph (1) by notices published in the London, Edinburgh and Belfast Gazettes not less than 21 days before that date.

(3) Where in any proceedings an enforcement authority produces a copy of a publication, it shall be presumed that the copy is a true copy of the edition of that publication that was in force at the time when the events that are the subject of the proceedings took place, unless evidence is adduced to the contrary.

Specified publicationsU.K.

321.—(1) In this regulation “specified publication” means any of the following—

(a)the European Pharmacopoeia;

(b)the British Pharmacopoeia;

(c)the Cumulative List of Recommended International Nonproprietary Names;

(d)a compendium prepared and published under regulation 317; or

(e)a list of names prepared and published under regulation 318.

(2) Paragraph (3) applies if an authorisation refers to a specified publication, but not to a particular edition of the publication.

(3) Where this paragraph applies, in order to determine whether anything done at a time when the authorisation is in force is done in accordance with the authorisation, the reference to a specified publication is to be construed as a reference to the edition of the specified publication in force at that time, unless the authorisation expressly provides otherwise.

(4) In paragraph (3) the reference to the edition of a specified publication in force at a particular time is a reference to the edition of that publication in force, under whatever title, at that time.

(5) In this regulation “authorisation” means any of the following—

(a)a manufacturer's licence;

(b)a wholesale dealer's licence;

(c)a [F1214UK] marketing authorisation;

F1215(ca)...

(d)an Article 126a authorisation;

(e)a certificate of registration; or

(f)a traditional herbal registration.

Textual Amendments

PART 16U.K.Enforcement

Validity of decisions and proceedingsU.K.

322.—(1) The validity of a decision of the licensing authority under Parts 3 (manufacturing and wholesale dealing), 5 (UK marketing authorisations), 6 (certification of homoeopathic medicinal products), 7 (traditional herbal medicinal products) or 8 (Article 126a authorisations) is not to be questioned in any legal proceedings.

(2) The validity of a licence, authorisation, certificate or registration granted or issued, or other thing done, in pursuance of a decision of a kind mentioned in paragraph (1) is not to be questioned in any legal proceedings.

(3) Paragraphs (1) and (2) are subject to the following provisions of this regulation.

(4) A person to whom notice of the decision is given may make an application to the High Court to challenge the validity of the decision on the grounds that—

(a)the decision is not within the powers conferred on the licensing authority; or

(b)a requirement of these Regulations in connection with the matter to which the decision relates has not been complied with.

(5) An application under paragraph (4) must be made within the period of three months beginning immediately after the day on which notice of the decision is given to the applicant.

(6) On an application under paragraph (4) the High Court may—

(a)make an interim order suspending the operation of the decision to which the application relates until the final determination of proceedings; or

(b)quash the decision, if satisfied that—

(i)the decision is not within the powers conferred by these Regulations, or

(ii)the interests of the applicant have been substantially prejudiced by a failure to comply with a requirement under these Regulations.

(7) If a decision to grant a licence, authorisation, certificate or registration is quashed under this regulation—

(a)a licence, authorisation, certificate or registration granted in pursuance of the decision is void; and

(b)the application process for the grant of the licence, authorisation, certificate or registration may be continued as if the decision had not been made.

(8) In the application of this regulation to Scotland, references to the High Court are to be construed as references to the Court of Session.

Modifications etc. (not altering text)

C5Reg. 322 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

Enforcement in England, Wales and ScotlandU.K.

323.—(1) The Secretary of State must enforce or secure the enforcement of these Regulations F1216... in England, Wales and Scotland.

(2) The Secretary of State may make arrangements for either or both of—

(a)the General Pharmaceutical Council; or

(b)in respect of each area for which there is a drugs authority, the drugs authority for the area,

to enforce the provisions of these Regulations listed in paragraph (3) to the extent specified in the arrangements.

(3) The provisions referred to in paragraph (2) are—

(a)regulations 251 (compliance with standards specified in certain publications) and 255(1)(e) (offences relating to dealings with medicinal products: compliance with standards specified in certain publications);

(b)Part 13 (packaging and leaflets); F1217... [F1218and]

(c)Part 14 Chapter 2 (requirements relating to advertising); [F1219and

F1220(d). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

(4) Arrangements made with the General Pharmaceutical Council under paragraph (2)(a) in relation to Part 14 Chapter 2 are to be limited to the enforcement of those provisions in respect of—

(a)advertisements displayed or representations made on or in any premises where medicinal products are sold by retail or supplied in circumstances corresponding to retail sale;

(b)advertisements displayed on any web site associated with such premises; and

(c)advertisements displayed on, or in close proximity to, a vending machine in which medicinal products are offered or exposed for sale.

F1221(4A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) The General Pharmaceutical Council must continue to enforce—

(a)regulations 214 (sale or supply of prescription only medicines) and 220 (sale or supply of medicines not subject to general sale); and

(b)in their application to or in relation to premises that are registered pharmacies, the provisions of these Regulations to which paragraph (7) applies.

(6) In each area for which there is a drugs authority, that drugs authority must continue to enforce the provisions of these Regulations to which paragraph (7) applies in their application to or in relation to premises that are not registered pharmacies.

(7) This paragraph applies to regulations 221 (sale or supply of medicinal products subject to general sale) and 222 (sale of medicinal products from automatic machines).

(8) Functions conferred by virtue of paragraphs (2), (5) and (6) are to be exercised concurrently with the Secretary of State.

(9) Nothing in this regulation confers a function on a person in relation to—

(a)a hospital (except so much of the hospital as is a registered pharmacy); or

(b)so much of any premises as is used as a doctor's or dentist's practice.

(10) In this regulation “drugs authority” means—

(a)in England—

(i)in relation to a non-metropolitan county, metropolitan district or London borough, the council of that county, district or borough, and

(ii)in relation to the City of London (including the Inner Temple and the Middle Temple), the Common Council of the City of London;

(b)in Wales, the council of a county or county borough; and

(c)in Scotland, a council constituted in relation to a local government area under section 2 of the Local Government etc (Scotland) Act 1994 M69.

(11) In this Part “premises” includes—

(a)any place; and

(b)a ship, aircraft, hovercraft or vehicle.

(12) Nothing in this regulation is to be construed as authorising any person other than the Lord Advocate or a procurator fiscal to institute proceedings in Scotland for an offence.

Textual Amendments

F1217Word in reg. 323(3)(b) omitted (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 14(a)(i) and word in reg. 323(3)(b) omitted (N.I.) (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 14(a)(i)

F1219Reg. 323(3)(d) and preceding word inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 14(a)(ii) and reg. 323(3)(d) and preceding word inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 14(a)(ii)

Modifications etc. (not altering text)

C6Reg. 323(1) applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

Marginal Citations

M691994 c.39. There is an amendment to section 2(1) that is not relevant to this regulation.

Enforcement in Northern IrelandU.K.

324.—(1) The Minister for Health, Social Services and Public Safety (in this regulation referred to as “the Minister”) must enforce or secure the enforcement of these Regulations and the relevant EU provisions in Northern Ireland.

(2) The Minister may make arrangements for a district council to enforce the provisions of these Regulations listed in paragraph (3) in its district to the extent specified in the arrangements.

(3) Those provisions are—

(a)regulations 221 (sale or supply of medicinal products subject to general sale), 222 (sale of medicinal products from automatic machines) and 255(6) (certain offences relating to dealings with medicinal products);

(b)regulations 251 (compliance with standards specified in certain publications) and 255(1)(e) (certain offences relating to dealings with medicinal products);

(c)Part 13 (packaging and leaflets); and

(d)Part 14 Chapter 2 (requirements relating to advertising).

(4) Functions conferred by virtue of paragraph (2) are to be exercised concurrently with the Minister.

(5) Regulation 323(9) has effect in relation to functions conferred by this regulation as it has effect in relation to functions conferred by regulation 323.

(6) In this regulation, “district council” means a council established under the Local Government Act (Northern Ireland) 1972 M70.

Modifications etc. (not altering text)

C7Reg. 324(1) applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

Marginal Citations

Rights of entryU.K.

325.—(1) An inspector may at any reasonable time enter premises—

(a)in order to determine whether there has been a contravention of a provision of these Regulations which the enforcement authority is required or empowered to enforce by virtue of regulations 323 and 324;

(b)in order to verify whether the data submitted in respect of an active substance used as a starting material in order to obtain a conformity certificate issued by the European Directorate for the Quality of Medicines and Healthcare (“EDQM”) comply with the monographs of the European Pharmacopoeia, if the EDQM asks the enforcement authority to do so; and

(c)for the purposes of any other function of the enforcement authority under these Regulations.

(2) A person may not exercise a right of entry under this regulation in relation to premises used only as a private dwelling unless 24 hours' notice has been given to the occupier.

(3) A person exercising, or attempting to exercise, a right of entry under this regulation must produce identification on request.

Modifications etc. (not altering text)

C8Regs. 325-330 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

Application for warrantU.K.

326.—(1) In a case where this regulation applies, a justice of the peace may issue a warrant authorising an inspector to enter premises, by force if necessary.

(2) This regulation applies if, on sworn information in writing, the justice of the peace is satisfied that—

(a)there are reasonable grounds for entering the premises by virtue of the enforcement authority's functions under these Regulations;

(b)an inspector has a right to enter them by virtue of regulation 325; and

(c)a condition specified in paragraph (3) is satisfied.

(3) Those conditions are—

(a)that—

(i)admission to the premises has been refused or is expected to be refused, and

(ii)notice of the intention to apply for a warrant has been given to the occupier;

(b)that a request for admission, or the giving of notice, would defeat the object of the entry;

(c)that the case is one of urgency; or

(d)that the premises are unoccupied or the occupier is temporarily absent.

(4) In relation to a ship, aircraft, hovercraft or vehicle, references in this Part to the occupier of premises are to be read as references to the master, commander or other person in charge of the ship, aircraft, hovercraft or vehicle.

(5) A warrant granted under this regulation continues in force for a period of 30 days beginning with the day on which the warrant is granted.

(6) In the application of this regulation to England, references to a justice of the peace include a reference to a district judge (magistrates' courts).

(7) In the application of this regulation to Scotland, references to a justice of the peace are to be read as references to a sheriff, stipendiary magistrate or justice of the peace.

(8) In the application of this regulation to Northern Ireland, references to a justice of the peace are to be read as references to a lay magistrate or a district judge (magistrates' courts).

Modifications etc. (not altering text)

C8Regs. 325-330 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

Powers of inspection, sampling and seizureU.K.

327.—(1) An inspector may inspect anything mentioned in paragraph (2)—

(a)in order to determine whether there has been a contravention of any provision of these Regulations which the enforcement authority must or may enforce by virtue of regulations 323 and 324;

(b)for the purpose described in regulation 325(1)(b) (verification of data at the request of the European Directorate for the Quality of Medicines and Healthcare); or

[F1222(c)in relation to an application under Parts 3 or 5 to 8 in order to verify any statement made by an applicant for—

(i)a manufacturer’s licence,

(ii)a wholesale dealer’s licence,

(iii)a brokering registration,

(iv)registration as an importer, manufacturer or distributor of active substances,

(v)a [F1223UK] marketing authorisation,

F1224(va). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(vi)a certificate of registration,

(vii)a traditional herbal registration, or

(viii)an Article 126a authorisation;

(d)in relation to a person’s notification to sell medicinal products at a distance under Part 12A.]

[F1225(2) The things mentioned in paragraph (1) are—

(a)a substance or article appearing to the inspector to be a medicinal product or an active substance;

(b)an article appearing to the inspector to be—

(i)a container or package used or intended to be used to contain a medicinal product or an active substance, or

(ii)a label or leaflet used or intended to be used in connection with a medicinal product or an active substance;

(c)plant or equipment, including computer equipment, appearing to the inspector to be used or intended to be used in connection with the manufacture, assembly, importation, sale, supply or advertising of, or wholesale dealing in, medicinal products or active substances;

(d)any process of manufacture or assembly of medicinal products or active substances;

(e)the way in which medicinal products or active substances, or the materials used in the manufacture of medicinal products or active substances, are tested at any stage in the process of manufacture or assembly;

(f)information and documents relating to the manufacture, assembly, importation, sale, supply or advertising of, or wholesale dealing in, medicinal products or active substances;

(g)information and documents relating to the safety of medicinal products or active substances, including information and documents relating to compliance with—

(i)conditions imposed under any of regulations 59 (conditions of UK marketing authorisation: general), 60 (conditions of UK marketing authorisation: exceptional circumstances), 61 (conditions of UK marketing authorisation: new obligations post-authorisation) or 105 (conditions of certificate of registration),

(ii)the requirements of Part 11 (pharmacovigilance),

(iii)obligations and conditions under Articles 10a(1), 14(7), 14(8), 16 or 57(2) of Regulation (EC) No 726/2004,

(iv)the requirements of Chapter 3 (pharmacovigilance) of Title II of Regulation (EC) No 726/2004,

[F1226(iva)the requirements of Schedule 12A (further provision as to the performance of pharmacovigilance activities);]

(v)the requirements of the Implementing Regulation as defined in regulation 177(5) (pharmacovigilance: interpreting provision), and

(vi)obligations under regulations 75 (obligation to provide information relating to safety) and 76 (obligation in relation to product information);

F1227(h). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) The inspector may for the purposes specified in paragraph (1) take or purchase a sample of a substance or article which appears to the inspector to be—

(a)a medicinal product or an active substance which is, or is intended to be, sold or supplied; or

(b)a substance or article used, or intended to be used, in the manufacture of a medicinal product or an active substance.

(4) The inspector may for the purposes specified in paragraph (1) require a person carrying on a business which consists of or includes the manufacture, assembly, importation, sale, supply or advertising of, or wholesale dealing in, medicinal products or active substances, or a person employed in connection with such a business, to produce information or documents relating to the business which are in the person’s possession or under the person’s control.]

F1228(4A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) The inspector may take copies of information or documents—

(a)inspected under sub-paragraph (2)(f) [F1229or (g)]; or

(b)produced under paragraph (4) F1230....

[F1231(6) The inspector may seize and retain a substance or article appearing to the inspector to be a medicinal product or an active substance if the inspector reasonably believes that an offence under these Regulations is being or has been committed in relation to, or by means of, that substance or article.]

(7) The inspector may, if the inspector reasonably believes that it may be required as evidence in proceedings, seize and retain—

(a)any document; or

(b)anything inspected, or discovered in the course of an inspection, under paragraph (1).

(8) The inspector may, if necessary, require a person who has the authority to do so—

(a)to open a container or package;

(b)to open a vending machine; or

(c)to allow the inspector to open a container, package or vending machine,

for the purpose of enabling the inspector to seize a substance, article, document or other thing under paragraph (6) or (7).

(9) The information and documents referred to in this regulation include any that are stored electronically.

Textual Amendments

F1222Reg. 327(4)(c)(d) substituted for reg. 327(4)(c) (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 29(2)

Modifications etc. (not altering text)

C8Regs. 325-330 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

Regulation 327: supplementaryU.K.

328.—(1) Where an inspector seizes a substance, article, document or other thing under regulation 327(6) or (7) (powers of inspection, sampling and seizure) the inspector—

(a)must, where practicable, inform—

(i)the person, if any, from whom it was seized, and

(ii)the occupier of the premises from which it was seized; or

(b)in relation to anything seized from a vending machine, must inform—

(i)the person whose name and address are stated on the machine to be those of the machine's owner, or

(ii)if no name and address are stated, the occupier of the premises on which the machine stands or to which it is affixed.

(2) An inspector exercising, or attempting to exercise, a right under regulation 327 must produce identification on request.

(3) The provisions of Schedule 31 have effect in relation to samples obtained by inspectors on behalf of enforcement authorities.

Modifications etc. (not altering text)

C8Regs. 325-330 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

Application of sampling procedure to substance or article seized under this PartU.K.

329.—(1) This regulation applies where an inspector seizes a substance or article under regulation 327 (powers of inspection, sampling and seizure).

(2) On request in accordance with paragraph (3), the inspector must either—

(a)set aside a sample of the substance or article seized; or

(b)treat the substance or article as a sample,

whichever seems more appropriate having regard to the nature of the substance or article.

(3) A request is made in accordance with this paragraph if—

(a)it is made by a person (“P”) who is entitled to be informed of the seizure under regulation 328; and

(b)it is made either at the time of the seizure or within the period of 21 days beginning with the day immediately after the day on which P is informed of the seizure.

(4) An inspector is not required by paragraph (2) to set aside a sample, or to treat a substance or article as a sample, if the nature of the substance or article is such that it is not reasonably practicable to do either of those things.

(5) An inspector must—

(a)divide a sample under paragraph (2) into three parts;

(b)mark each part;

(c)seal or fasten each part; and

(d)supply one part to P.

(6) Paragraphs 10 to 12 and 15 to 26 of Schedule 31 apply to a sample under this regulation as they apply to a sample obtained as mentioned in paragraph 1 of that Schedule, but as if—

(a)references to the preceding provisions of that Schedule were references to the preceding provisions of this regulation;

(b)references to a sampling officer were references to an inspector who seized a substance or article under regulation 327 (powers of inspection, sampling and seizure); and

(c)a reference to the relevant enforcement authority were a reference to the authority by which the inspector is authorised.

Modifications etc. (not altering text)

C8Regs. 325-330 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

Analysis of samples: other casesU.K.

330.—[F1232(1) This regulation applies where a person other than an inspector or a person authorised by an enforcement authority has purchased an active substance or a medicinal product.

(2) The person may submit a sample of the active substance or medicinal product for analysis to the public analyst for the area in which the active substance or medicinal product was purchased or, if for the time being there is no public analyst for the area, to the public analyst for another area.]

(3) Paragraphs 2 to 13 of Schedule 31 have effect, in relation to a person proposing to submit a sample in pursuance of paragraph (2), as if in that Schedule references to the sampling officer were references to that person.

(4) A public analyst to whom a sample is submitted under this regulation must analyse the sample, or cause it to be analysed, as soon as practicable (but this is subject to the following provisions of this regulation).

(5) If the public analyst to whom a sample is submitted thinks that a proper analysis cannot be carried out for any reason, the public analyst must send it to the public analyst for some other area, who must as soon as practicable analyse the sample, or cause it to be analysed (subject to paragraph 6).

(6) A public analyst to whom a sample is submitted or sent under this regulation may demand payment in advance of the required fee, and if payment in advance is demanded may refuse to carry out the analysis until the fee is paid.

(7) A public analyst who has analysed a sample or caused it to be analysed must issue a certificate specifying the result of the analysis to the person by whom the sample was submitted under paragraph (2).

(8) Paragraphs 21 to 23 of Schedule 31 have effect in relation to a certificate issued under this regulation as they have effect in relation to a certificate issued under paragraph 19 of that Schedule.

(9) In this regulation “public analyst”—

(a)in relation to England and Wales and Scotland has the meaning given by section 27 of the Food Safety Act 1990 M71; and

(b)in relation to Northern Ireland has the meaning given by Article 27(1) of the Food Safety (Northern Ireland) Order 1991 M72.

Textual Amendments

Modifications etc. (not altering text)

C8Regs. 325-330 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

Marginal Citations

M711990 c.16. Section 27 was amended by the Local Government etc (Scotland) Act 1994 section 180(1) and Schedule 18 paragraph 163(3), the Food Standards Act 1999 section 40(1) and Schedule 5 paragraphs 7 and 8, the Local Government (Wales) Act 1994 section 22(3) and Schedule 9 paragraph 16(2), S.I. 1994/865 regulation 24, and the Local Government and Public Involvement in Health Act 2007 sections 22 and 241, Schedule 1 Part 2 paragraph 17, and Schedule 18 Part 1.

M721991 No. 762 (N.I. 7). There are amendments not relevant to these Regulations.

Findings and reports of inspectionsU.K.

331.—(1) If the outcome of the inspection of things referred to in regulation 327(2)(g) (powers of inspection, sampling and seizure: information and documents relating to safety etc) is that the holder of a [F1233UK marketing authorisation F1234...] or traditional herbal registration does not comply with the pharmacovigilance system as described in the pharmacovigilance system master file, or any provision of Part 11 (pharmacovigilance), the enforcement authority must—

(a)bring the deficiencies to the attention of the holder;

(b)give the holder the opportunity to submit comments; and

(c)[F1235in the case of a product authorised under a UKMA(NI) or [F1236UKMA(UK)(Category 2)],] inform the other EEA States, the EMA and the European Commission.

(2) Paragraph (1) is without prejudice to paragraphs (3) and (5).

(3) After every inspection carried out in accordance with regulations 325 (rights of entry) and 327 (powers of inspection, sampling and seizure) in connection with medicinal products other than registrable homoeopathic medicinal products, the enforcement authority must report on whether the activities to which the inspection relates comply with such of the provisions mentioned in paragraph (4) as apply to those activities.

(4) Those provisions are—

(a)the Good Manufacturing Practice Directive and any principles or guidelines of good manufacturing practice referred to in Article 47 of the 2001 Directive;

[F1237(b)the guidelines on good distribution practice—

(i)in the case of Great Britain, published under, or that apply by virtue of, regulation C17;

(ii)in the case of Northern Ireland, published by the European Commission in accordance with Article 84 of the 2001 Directive;]

(c)in the case of the holder of a marketing authorisation or traditional herbal registration—

(i)Part 11 (pharmacovigilance), and

(ii)Chapter 3 (pharmacovigilance) of Title II (authorisation and supervision of medicinal products for human use) of Regulation (EC) No 726/2004.

[F1238(d)Schedule 12A; and

(e)the Implementing Regulation (as defined in regulation 177(5)).]

(5) The enforcement authority must before adopting the report —

(a)communicate the content of the report to the person to whose activities the inspection relates; and

(b)give that person the opportunity to submit comments.

Textual Amendments

[F1239Guidelines on inspectionsU.K.

331A.—(1) The licensing authority may publish guidelines specifying the principles applicable to inspections referred to in this Part.

(2) Guidelines under paragraph (1) may include the form and content of reports under regulation 331 and of certificates of good manufacturing practice or good distribution practice.

(3) Until the licensing authority exercises its power under paragraph (1), the guidelines adopted by the European Commission under Article 111a of the 2001 Directive, as they had effect immediately before IP completion day, are to continue to apply.]

Textual Amendments

Restrictions on disclosure of informationU.K.

332.—(1) A person (“P”) must not disclose to another person, otherwise than in the performance of P's functions—

(a)any information relating to a manufacturing process or trade secret obtained by P on premises which P has entered by virtue of regulation 325 or of a warrant under regulation 326; or

(b)any information obtained by P or given to P in pursuance of these Regulations.

(2) Paragraph (1) does not apply if—

(a)P is, or is acting on behalf of, a public authority for the purposes of the Freedom of Information Act 2000 M73; and

(b)the information is not held by the authority on behalf of another person.

Modifications etc. (not altering text)

C9Regs. 332-339 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

Marginal Citations

Protection for inspectorsU.K.

333.—(1) An inspector is not personally liable in respect of any act done in the execution, or purported execution, of a function under these Regulations and within the scope of the inspector's employment by an enforcement authority (or, where the inspector is not employed by the authority, the scope of the inspector's authorisation), provided that the act was done in the honest belief that these Regulations required or permitted it.

(2) Where an action is brought against an inspector in respect of an act falling within paragraph (1), the enforcement authority may indemnify the inspector against any damages, costs or expenses incurred, if the authority is satisfied that the inspector honestly believed that these Regulations required or permitted the act.

(3) Paragraph (2) applies in a case where the person is not legally entitled to require an indemnity from the enforcement authority.

(4) A reference to an inspector in this regulation includes a reference to an employee of the licensing authority who accompanies an inspector pursuant to regulation 334(1).

Modifications etc. (not altering text)

C9Regs. 332-339 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

Supplementary provisions and offencesU.K.

334.—(1) An inspector entering any premises by virtue of regulation 325 or of a warrant under regulation 326 may be accompanied by such persons, and take such equipment, as the inspector thinks appropriate.

(2) Where an inspector enters premises in pursuance of a warrant under regulation 326, the inspector must, if the property is unoccupied or the occupier is temporarily absent, leave the premises as effectively secured against trespass as they were before the inspector entered.

(3) It is an offence for a person—

(a)intentionally to obstruct an inspector;

(b)intentionally to fail to comply with a requirement properly made under regulation 327 by an inspector; or

(c)without reasonable cause, to fail to give an inspector any other assistance or information which the inspector may reasonably require in order to perform a function under these Regulations.

(4) A person guilty of an offence under paragraph (3) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.

(5) A person who knowingly makes a false statement in giving information as mentioned in paragraph (3)(c) is guilty of an offence.

(6) A person who breaches the prohibition in regulation 332(1) (restrictions on disclosure of information) is guilty of an offence.

(7) A person who is guilty of an offence under paragraph (5) or (6) is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment to a fine or to imprisonment for a term not exceeding two years, or to both.

(8) Nothing in this regulation is to be read as requiring a person to answer a question or to give information if doing so might incriminate that person or the spouse or civil partner of that person.

(9) In this regulation “occupier”, in relation to a ship, aircraft, or vehicle, is to be read in accordance with regulation 326(4).

Modifications etc. (not altering text)

C9Regs. 332-339 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

PART 17U.K.Miscellaneous and general

Provisions relating to offencesU.K.

Contravention due to fault of another personU.K.

335.—(1) This regulation applies where—

(a)a contravention of a provision referred to in paragraph (6) constitutes an offence; and

(b)a person (“A”) contravenes the provision by reason of the act or omission of another person (“B”).

(2) B may be charged with and convicted of the offence, whether or not proceedings are also brought against A.

(3) If B is convicted B is liable to the same punishment as would have been imposed on A if A had been convicted of the offence.

(4) If A is charged with the offence it is a defence for A to prove on the balance of probabilities that—

(a)A exercised all due diligence to avoid contravening the provision; and

(b)the contravention was due to the act or omission of B.

(5) A may not rely on the defence in paragraph (4) unless not later than seven clear days before the date of the hearing A serves on the prosecutor a notice in writing of any information held by A which identifies, or assists in identifying, B.

(6) The provisions mentioned in paragraph (1) are—

(a)regulation 251 (compliance with standards specified in certain publications);

(b)regulations [F1240268, 268A, 269 and 269A] (offences relating to packaging and package leaflets);

(c)regulation 273 (child resistant containers for regulated medicinal products);

(d)regulation 275 (colouring of aspirin and paracetamol products for children);

(e)any prohibition or requirement in Chapter 2 of Part 14 (advertising); and

(f)regulations 305(4) and 306(7) and (8) (notices not to publish, or to cease to publish, an advertisement.

Textual Amendments

Modifications etc. (not altering text)

C9Regs. 332-339 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

Warranty as defenceU.K.

336.—(1) This regulation applies where proceedings are brought against a person (“the defendant”) for an offence under these Regulations in respect of a contravention of a provision mentioned in paragraph (3).

(2) It is a defence for the defendant to prove that—

(a)the substance or article to which the contravention relates (the “relevant substance or article”) was sold to the defendant in the United Kingdom as—

(i)a substance or article which could be lawfully sold, supplied or offered for sale or supply, or

(ii)a substance or article which could be lawfully sold, supplied or offered for sale or supply under the name or description or for the purpose under or for which it was sold;

(b)the relevant substance or article was sold with a written warranty certifying a matter specified in paragraph (a), and that if the warranty were true the alleged offence would not have been committed;

(c)at the time of the commission of the alleged offence the defendant had no reason to believe that the matter certified in the warranty was otherwise; and

(d)at the time of the commission of the alleged offence the relevant substance or article was in the same state as when the defendant purchased it.

(3) The provisions are—

(a)regulation 251 (compliance with standards specified in certain publications);

(b)regulations [F1241268, 268A, 269 and 269A] (offences relating to packaging and package leaflets);

(c)regulation 273 (child resistant containers for regulated medicinal products); and

(d)regulation 275 (colouring of aspirin and paracetamol products for children).

(4) A warranty is not to be a defence under this regulation unless, no later than three clear days before the date of the hearing, the defendant sends to the prosecutor, and to the person who gave the warranty to the defendant—

(a)a copy of the warranty;

(b)a notice stating that the defendant intends to rely on it; and

(c)the name and address of the person from whom the defendant received the warranty.

(5) Where the defendant is an employee of the person who purchased the substance or article under the warranty, the defendant is entitled to rely on the provisions of this regulation in the same way as the employer.

(6) The person by whom the warranty is alleged to have been given is entitled to appear at the hearing and to give evidence.

(7) The court may adjourn the hearing in order to enable a person to appear and give evidence in accordance with paragraph (6).

(8) For the purposes of this regulation, a name or description entered in an invoice is to be deemed to be a written warranty that the article or substance to which the name or description applies can be sold, supplied, or offered or exposed for sale under that name or description without contravening a provision mentioned in paragraph (3).

(9) In the application of this regulation and regulation 337 to Scotland, references to the defendant are to be construed as references to the accused.

Textual Amendments

Modifications etc. (not altering text)

C9Regs. 332-339 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

Offences in relation to warranties and certificatesU.K.

337.—(1) It is an offence for a defendant in proceedings for an offence under these Regulations in respect of a contravention of a provision mentioned in regulation 336 (3)—

(a)intentionally to apply a warranty given in relation to one substance or article to a different substance or article; or

(b)intentionally to apply to one substance or article a certificate issued under regulation 330 or paragraph 19 of Schedule 31 in relation to a sample of a different substance or article.

(2) A person who intentionally or recklessly gives a purchaser a false warranty certifying a matter specified in regulation 336(2)(a) is guilty of an offence.

(3) If the defendant in proceedings for an offence under these Regulations in respect of a contravention of a provision mentioned in regulation 336(3) relies successfully on a warranty given to the defendant or to the defendant's employer, proceedings for an offence under paragraph (2) may be brought in accordance with paragraph (4).

(4) Proceedings may be brought, as the prosecutor chooses—

(a)before a court which has jurisdiction in the place where a sample of the substance or article to which the warranty relates was taken; or

(b)before a court which has jurisdiction in the place where the warranty was given.

(5) A person guilty of an offence under this regulation is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment to a fine or to imprisonment for a term not exceeding two years, or to both.

Modifications etc. (not altering text)

C9Regs. 332-339 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

Offences by bodies corporate and partnershipsU.K.

338.—(1) If an offence under these Regulations committed by a body corporate is proved to have been committed with the consent or connivance of, or to be attributable to neglect on the part of, an officer of the body corporate, or a person purporting to act as an officer of the body corporate, that officer or person (as well as the body corporate) is guilty of the offence and is liable to be proceeded against and punished accordingly.

(2) If the affairs of a body corporate are managed by its members, paragraph (1) applies in relation to the acts and omissions of a member in connection with the member's functions of management as it applies to an officer of the body corporate.

(3) If an offence under these Regulations is—

(a)committed by a Scottish partnership; and

(b)proved to have been committed with the consent or connivance of, or to be attributable to neglect on the part of, a partner of the partnership,

the partner (as well as the partnership) is guilty of the offence and is liable to be proceeded against and punished accordingly.

(4) In this regulation “officer” in relation to a body corporate means a director, secretary or other similar officer of the body corporate.

Modifications etc. (not altering text)

C9Regs. 332-339 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

ProsecutionsU.K.

ProsecutionsU.K.

339.—(1) A magistrates' court in England or Wales may try an information for an offence under these Regulations that is triable only summarily if the information was laid at any time within the period of twelve months beginning with the commission of the offence.

(2) Summary proceedings in Scotland for an offence triable only summarily under these Regulations may be commenced at any time within the period of twelve months beginning with the commission of the offence (and section 136(3) of the Criminal Procedure (Scotland) Act 1995 M74 applies for the purposes of this paragraph as it applies for the purposes of that section).

(3) A magistrates' court in Northern Ireland may hear and determine a complaint for an offence punishable on summary conviction under these Regulations, other than an offence which is also triable on indictment, if the complaint was made at any time within the period of twelve months beginning with the commission of the offence.

(4) A body referred to in regulation 323(2) (enforcement in England, Wales and Scotland) may not institute proceedings for an offence under these Regulations in relation to a contravention of a provision which it may or must enforce by virtue of arrangements made under that regulation unless it has given no less than 28 days' notice of its intention to do so, together with a summary of the facts on which the charges are founded, to the Secretary of State.

(5) A district council (as defined in regulation 324 (enforcement in Northern Ireland)) may not institute proceedings for an offence under these Regulations in relation to a contravention of a provision which it may or must enforce by virtue of arrangements made under regulation 324(2) unless it has given no less than 28 days' notice of its intention to do so, together with a summary of the facts on which the charges are founded, to the Minister for Health, Social Services and Public Safety.

(6) A certificate of the Secretary of State or of the Minister for Health, Social Services and Public Safety that the requirements of paragraph (4) or, as the case may be, (5) have been complied with is to be conclusive evidence that the requirements have been complied with, and a document purporting to be such a certificate is to be presumed to be such a certificate unless the contrary is proved.

Modifications etc. (not altering text)

C9Regs. 332-339 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

Marginal Citations

GeneralU.K.

PresumptionsU.K.

340.—(1) Paragraph (2) applies for the purposes of proceedings under these Regulations for an offence consisting of offering a medicinal product for sale by retail in contravention of regulation 220 (sale or supply of products not subject to general sale) or 221 (sale or supply of products subject to general sale).

(2) If it is proved that the medicinal product in question was found on a vehicle from which medicinal products are sold, it is to be presumed, unless the contrary is proved, that the person in charge of the vehicle offered the medicinal product for sale.

(3) Paragraph (4) applies for the purposes of proceedings under these Regulations for an offence consisting of a contravention of a provision within paragraph (5), where it is proved that the medicinal product in question was found on premises at which the person charged with the offence carries on a business consisting of or including the sale or supply of medicinal products.

(4) It is to be presumed, unless the contrary is proved, that the person charged possessed the medicinal product for the purpose of sale or supply.

(5) The provisions within this paragraph are regulations [F1242268 (offences relating to packaging and package leaflets in Great Britain: authorisation holders), 268A (offences relating to packaging and package leaflets in Northern Ireland: authorisation holders), 269 (offences relating to packaging and package leaflets in Great Britain: other persons), 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons)] and 276 (offences: requirements relating to child safety) to the extent that they establish an offence based on possession of a medicinal product for the purpose of sale or supply.

Textual Amendments

Decisions under these RegulationsU.K.

341.—(1) Where the licensing authority notifies a person of a decision under these Regulations, it must—

(a)state its reasons for the decision; and

(b)inform the person of any action the person may take under these Regulations to challenge that decision and of the time for taking that action.

(2) Paragraph (1) is without prejudice to any other provision of these Regulations concerning notification by the licensing authority.

(3) The licensing authority must publicise any decision under these Regulations to which paragraph (4) applies in such manner as it thinks fit.

(4) Those decisions are—

(a)a decision to grant or revoke a [F1243UK] marketing authorisation;

F1244(aa). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)a decision to grant or revoke a certificate of registration; and

(c)a decision to grant or revoke a traditional herbal registration.

Textual Amendments

Time limits for provision of information etcU.K.

342.—(1) This regulation applies if—

(a)by any provision of these Regulations a person is required to provide—

(i)any information or document to the licensing authority or to the Ministers, or

(ii)any assistance to the licensing authority or to the Ministers; and

(b)no time is specified in that provision within which the obligation must be performed.

(2) The obligation must be performed within such time as may be specified in a written notice given to the person by the licensing authority or the Ministers (as the case may be).

Service of documentsU.K.

343.—(1) A notice or other document required or authorised by any provision of these Regulations to be served on a person, or to be given or sent to a person, may be served, given or sent—

(a)by delivering it to the person;

(b)by sending it by post to the person's usual or last known residence or place of business in the United Kingdom;

(c)in the case of a body corporate, by delivering it to the secretary or clerk of the body corporate at its registered or principal office or by sending it by post to the secretary or clerk of the body corporate at that office; or

(d)in the case of a Scottish partnership by delivering it to a partner or by sending it by post to the address of the principal office of the partnership; or

(e)if the person consents in writing to the use of electronic communication, by a means of electronic communication.

(2) Where a notice or other document is sent by means of electronic communication it is treated for the purposes of these Regulations as received on the day on which it is sent, unless the contrary is proved.

Modifications etc. (not altering text)

C10Reg. 343 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

Payment of expenses by MinistersU.K.

344.—(1) If a person enforces a provision of these Regulations in accordance with functions conferred under Part 16 (enforcement), the relevant Minister must pay such amounts as the person may reasonably require in respect of expenses incurred in the course of enforcement.

(2) In paragraph (1) “the relevant Minister” means—

(a)in relation to enforcement in England, Wales, and Scotland, the Secretary of State; and

(b)in relation to enforcement in Northern Ireland, the Minister for Health, Social Services and Public Safety.

[F1245Modifications to deal with serious shortagesU.K.

344A.—(1) The Ministers may by regulations modify the application of any of the specified provisions in circumstances where the United Kingdom, or any part of the United Kingdom, is experiencing or may experience a serious shortage of medicinal products, or of medicinal products of a specified description, arising from the withdrawal of the United Kingdom from the European Union.

(2) Regulations may only be made under paragraph (1) for the purposes of preventing, remedying or mitigating the serious shortage that is being or may be experienced.

(3) For the purposes of paragraph (1), the “specified provisions” are the provisions of Parts 1, 3 to 5, 10 to 13 and 16, and of the associated Schedules.

(4) The reference in paragraph (1) to a serious shortage arising from the withdrawal of the United Kingdom from the European Union includes reference to a serious shortage where the withdrawal of the United Kingdom from the European Union is one but not the only significant factor contributing to the shortage.

(5) No regulations under paragraph (1) may be made, or have effect, after the end of the period of two years beginning with IP completion day.

Textual Amendments

Regulation making powersU.K.

344B.—(1) Regulations made under a power in the regulations listed in paragraph (2)—

(a)are to be made by statutory instrument;

(b)may make different provision for different purposes and different areas; and

(c)may include incidental, supplemental, consequential, transitional, transitory or saving provisions, including consequential amendments to these Regulations.

(2) The regulations referred to in paragraph (1) are—

(a)regulation B17(1) and (4) (good manufacturing practice);

(b)regulation 50(5A) (Annex I to the 2001 Directive);

(c)regulation 50G(5) (orphan criteria etc);

(d)regulations 59(3A) and 61(7A) (post-authorisation efficacy studies);

(e)regulation 65C(7) (variations of UK marketing authorisations);

(f)regulation 102(7) (homoeopathic medicinal products);

(g)regulation 205A(2) (further obligations in respect of pharmacovigilance activities);

(h)regulation 257E (certain forms of labelling); and

(i)regulation 344A (modifications to deal with serious shortages).

(3) A statutory instrument containing regulations made under the powers listed in paragraph (2) is subject to annulment in pursuance of a resolution of either House of Parliament.]

Textual Amendments

Immunity from civil liabilityU.K.

Immunity from civil liabilityU.K.

345.—(1) This regulation applies where the licensing authority makes a recommendation or requirement to which paragraph (2) applies in response to the suspected or confirmed spread of—

(a)pathogenic agents;

(b)toxins;

(c)chemical agents; or

(d)nuclear radiation,

which may cause harm to human beings.

(2) This paragraph applies to a recommendation or requirement—

(a)for the use of a medicinal product without an authorisation; or

(b)for the use of a medicinal product with an authorisation, but for a therapeutic indication that is not permitted under the authorisation.

(3) None of the following are to be subject to any civil liability for any loss or damage resulting from the use of the product in accordance with the recommendation or requirement—

(a)any holder of an authorisation for the product;

[F1246(aa)if there is no holder of an authorisation for the product but the sale or supply of the product is authorised by the licensing authority on a temporary basis under regulation 174, the person responsible for placing the product on the market in the United Kingdom;]

(b)any manufacturer of the product;

(c)any officer, servant, employee or agent of a person within [F1247sub-paragraph (a), (aa) or (b);]

(d)any health care professional[F1248; or]

[F1249(e)any person, not being a health care professional, who administers the product in accordance with a protocol of the type mentioned in regulation 247A.]

(4) This regulation does not apply in relation to liability under section 2 (liability for defective products) of the Consumer Protection Act 1987M75 or article 5 of the Consumer Protection (Northern Ireland) Order 1987M76.

(5) In this regulation “authorisation” means a [F1250UK marketing authorisation F1251...], certificate of registration, traditional herbal registration or Article 126a authorisation.

Textual Amendments

Marginal Citations

M751987 c.43. Section 2(4) was repealed in relation to England and Wales by S.I. 2000/2771 article 2(1) and (3) and in relation to Scotland by S.S.I. 2001/265 article 2(1) and (3).

[F1252Obligation on licensing authority to maintain list of medicinal products to which derogations have appliedU.K.

345A.—(1) The licensing authority must publish a list of medicinal products to which the derogations described in Articles 5a, 8(2a) and (2b), 18a, 20 (second paragraph), 40(1a) and (3a), 48(3) and 104(3) of the 2001 Directive have applied.

(2) The licensing authority must update the list referred to in paragraph (1) at least every six months.]

Textual Amendments

ReviewU.K.

[F1253ReviewU.K.

346.—(1) The Secretary of State must from time to time carry out a review of the provisions listed in paragraph (2).

(2) Those provisions are—

(a)Chapters 1, 3 and 4 of Part 3;

(b)Parts 11 and 12A;

(c)regulations—

[F1254(ai)17A,

(bi)17B,]

(i)[F125518(6)],

(ii)20(1),

[F1256(iiza)27A,

(iizb)29A,

(iizc)29B]

F1257(iia). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iii)37(4)(b), (5), (6), (11) and (12),

[F1258(iiiza)37A,

(iiizb)37B,]

F1259(iiia). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iv)43(5), (6)(a) [F1260and (d)], 7(c)(iii) and (vii), (8) and [F1261(12)] to (14),

F1262(iva). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(v)44(1) to (6),

[F1263(va)50K,]

(vi)59,

(vii)60(3)(b), (9) and (10),

(viii)61,

(ix)63,

(x)64(4)(b), (d) and (e), (5)(a) and (6)(c),

(xi)65(2),

(xii)66(5) and (6),

(xiii)68(2)(a) and (b), (5) and (12A),

(xiv)69(2)(a) and (b), (5) and (10),

[F1264(xiva)73(5A) to (5C),]

[F1265(xivb)74A,

(xivc)74B,]

(xv)75(2)(b) and (c),

(xvi)76,

(xvii)79,

F1266(xviia). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F1267(xviii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F1268(xix). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F1269(xixa). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(xx)97,

(xxi)105(3)(b),

(xxii)107(2),

(xxiii)108(5),

(xxiv)110(8A),

[F1270(xxiva)113(3A),]

(xxv)115(2)(b) and (c),

(xxvi)132(2),

(xxvii)133(5) and (6),

(xxviii)135(10A),

[F1271(xxviiia)142(5A) to (5C),]

[F1272(xxviiiaza)regulations 167A [F1273to 167H],]

[F1274(xxviiiazb)170A,

(xxviiiazc)170B,]

[F1275(xxviiiaa)regulation 174A,]

[F1276(xxviiib)213(3),]

[F1277(xxviiiba)214(5C) [F1278and (5D)],]

[F1276(xxviiic)217A,]

[F1276(xxviiid)218(2)(b) and (c), (3) and (5),]

[F1279(xxviiie)219 and 219A,]

[F1280(xxviiiezb)220B,]

[F1281(xxviiiea)223(3)(b),]

[F1282(xxviiieb)226A,]

[F1283(xxviiieb)228(2)(d)(iv),]

[F1284(xxviiif)229(1)(db) and (dc) [F1285and (2)],

[F1286(xxviiifa)233(1)(a)(ivd) and (ive),]

(xxviiig)234(2)(e),]

[F1287(xxviiiga)[F1288regulation 235A],]

[F1289(xxviiih)248(1)(a) and (2)(a),]

F1290(xxviiii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F1291(xxviiij). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F1292(xxviiik)257CA,]

(xxix)266(4) and (5),

(xxx)327(2)(g) and insofar as the provision relates to active substances paragraphs (1)(c)(iii), (iv) and (viii), (2)(a) to (f), (3), (4) and (6),

(xxxi)330(1) and (2),

(xxxii)331, and

(xxxiii)regulation 349 insofar as it repeals section 10(7) of the Medicines Act 1968; and

(d)Schedules—

(i)5 paragraphs 1(1)(b) to (d), (2)(b) to (d), 3(11)(b)(vi) to (viii), 5(2)(f) to (h),

F1293(ia). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(ii)7A,

(iii)8 paragraphs 9A, 12, 13, 19 and 23,

(iv)12 paragraph 21,

[F1294(ivza)16, Part 2 entries relating to [F1295“the United Kingdom Health Security Agency”] and “Public Health Agency” and Part 3 entries relating to “search and rescue operations”,]

(iva)17, Part 1 items 12 and 13, Part 2 items F1296... 11 and 12, [F1297Part 3 item 11,] Part 4 items 11 to 13 and Part 5 items F1296... 18 [F1298to 20],

(ivaa)23, paragraph 1(a)(vii) to [F1299(x)],

[F1300(ivab)24 paragraph 18A,]

[F1301(ivb)22, entries relating to [F1302“the United Kingdom Health Security Agency”], “Public Health Agency” and “search and rescue operations”, and]

(v)27 paragraphs 14 and 15.

(3) The Secretary of State must—

(a)set out the conclusions of a review carried out in accordance with paragraph (1) in a report; and

(b)publish the report.

[F1303(4) In carrying out the review the Secretary of State must, so far as is reasonable, have regard to how—

(a)the 2001 Directive;

(b)Directive 2010/84/EU of the European Parliament and of the Council of 15 October 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use;

(c)Article 11 of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare;

(d)Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products; and

(e)Commission Implementing Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescriptions issued in another Member State,

are implemented in other member States in relation to the subject matter of the provisions mentioned in paragraph (2).]

(5) The report must in particular—

(a)set out the objectives intended to be achieved by the regulatory system established by the provisions of these Regulations that implement those Directives in relation to the subject matter of the provisions mentioned in paragraph (2)(a), (b), (c)(i) to [F1304(xxxii)] and (d);

(b)assess the extent to which those objectives are achieved; and

(c)assess whether those objectives remain appropriate and, if so, the extent to which they could be achieved with a system that imposes less regulation.

(6) The first report under this regulation must be published before the end of the period of five years beginning with the day on which these Regulations come into force.

(7) Reports under this regulation are afterwards to be published at intervals not exceeding five years.]

Textual Amendments

F1255Word in reg. 346(2)(c)(i) substituted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 15(2)(a)(i) and word in reg. 346(2)(c)(i) substituted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 15(2)(a)(i)

F1260Words in reg. 346(2)(c)(iv) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 15(2)(a)(ii) and words in reg. 346(2)(c)(iv) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 15(2)(a)(ii)

F1276Reg. 346(2)(c)(xxviiib)-(xxviiie) inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 9(2)(a) and reg. 346(2)(c)(xxviiib)-(xxviiie) inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 9(2)(a)

F1277Reg. 346(2)(c)(xxviiiba) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 15(2)(a)(iii) and reg. 346(2)(c)(xxviiiba) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 15(2)(a)(iii)

F1278Words in reg. 346(2)(c)(xxviiiba) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 11(2)(a)(i) and words in reg. 346(2)(c)(xxviiiba) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 11(2)(a)(i)

F1279Reg. 346(2)(c)(xxviiie) substituted (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 8 and reg. 346(2)(c)(xxviiie) substituted (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 8

F1281Reg. 346(2)(c)(xxviiiea) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 15(2)(a)(iv) and reg. 346(2)(c)(xxviiiea) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 15(2)(a)(iv)

F1282Reg. 346(2)(c)(xxviiieb) inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 16(a)(v) and reg. 346(2)(c)(xxviiieb) inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 16(a)(v)

F1283Reg. 346(2)(c)(xxviiieb) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 11(2)(a)(ii) and reg. 346(2)(c)(xxviiieb) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 11(2)(a)(ii)

F1284Reg. 346(2)(c)(xxviiif)(xxviiig) inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 6(2)(a) and reg. 346(2)(c)(xxviiif)(xxviiig) inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 6(2)(a)

F1285Words in reg. 346(2)(c)(xxviiif) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 15(2)(a)(v) and words in reg. 346(2)(c)(xxviiif) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 15(2)(a)(v)

F1288Words in reg. 346(2)(c)(xxviiiga) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 12

F1289Reg. 346(2)(c)(xxviiih) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 15(2)(a)(vi) and reg. 346(2)(c)(xxviiih) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 15(2)(a)(vi)

F1294Reg. 346(2)(d)(ivza) inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 6(2)(b)(i) and reg. 346(2)(d)(ivza) inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 6(2)(b)(i)

F1297Words in reg. 346(2)(d)(iva) inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 7 and words in reg. 346(2)(d)(iva) inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 7

F1298Words in reg. 346(2)(d)(iva) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 11(2)(b)(i) and words in reg. 346(2)(d)(iva) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 11(2)(b)(i)

F1299Word in reg. 346(2)(d)(ivaa) substituted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 11(2)(b)(ii) and word in reg. 346(2)(d)(ivaa) substituted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 11(2)(b)(ii)

F1301Reg. 346(2)(d)(ivb) inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 6(2)(b)(iii) and reg. 346(2)(d)(ivb) inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 6(2)(b)(iii)

F1304Word in reg. 346(5)(a) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 9(4) and word in reg. 346(5)(a) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 9(4)

Transitional provisions, savings, amendments, repeals and revocationsU.K.

Transitional provisions and savingsU.K.

347.  Schedule 32 contains transitional provisions and savings.

[F1305Transitional provision in relation to EU exitU.K.

347A.  Schedule 33A contains transitional provision in relation to the EU Exit Regulations.]

Textual Amendments

[F1306Transitional provision relating to the Windsor FrameworkU.K.

347B.—(1) Schedule 33B contains transitional provision in relation to the implementation of the Windsor Framework.

(2) In paragraph (1), “the Windsor Framework” means the part of the withdrawal agreement known as the Windsor Framework by virtue of Joint Declaration No. 1/2023 of 24 March 2023 made between the European Union and the United Kingdom in the Joint Committee established by the withdrawal agreement.]

Textual Amendments

Amendments to existing lawU.K.

348.  Schedule 34 contains amendments to existing law.

Repeals and revocationsU.K.

349.  Schedule 35 contains repeals and revocations.

Signed by authority of the Secretary of State for Health.

Earl Howe

Parliamentary Under-Secretary of State

Department of Health

Edwin Poots

Minister for Health, Social Services and Public Safety

SCHEDULES

Regulation 5

SCHEDULE 1U.K.Further provisions for classification of medicinal products

PART 1U.K.Descriptions of certain medicinal products to be available only on prescription

1.  The following medicinal products shall be available only on prescription—U.K.

(a)a product for parenteral administration;

(b)a product that is a controlled drug [F1307as defined in section 2(1)(a) of the Misuse of Drugs Act 1971], unless it is covered by a [F1308UK] marketing authorisation in which the product is classified as a pharmacy medicine or as a medicinal product subject to general sale;

(c)cyanogenic substances, other than preparations for external use;

(d)medicinal substances that on administration emit radiation, or contain or generate any substance which emits radiation, in order that radiation may be used;

(e)a product that—

(i)is covered by a [F1309UK marketing authorisation F1310..., Article 126a authorisation or parallel import licence] in which the product is classified as a pharmacy medicine or as a medicinal product subject to general sale, and

(ii)consists of or contains aloxiprin, aspirin or paracetamol in the form of non-effervescent tablets or capsules;

(f)a product that—

(i)is covered by a [F1311UK marketing authorisation F1312..., Article 126a authorisation or parallel import licence] in which the product is classified as a pharmacy medicine or as a medicinal product subject to general sale, and

(ii)consists of or contains (in any pharmaceutical form) pseudoephedrine salts or ephedrine base or salts; F1313...

(g)a product that—

(i)is not covered by a [F1314UK marketing authorisation F1315..., Article 126a authorisation or parallel import licence], and

(ii)is a prescription only medicine by virtue of articles 5 and 10 of, and Schedules 1 and 2 to, the Prescription Only Medicines (Human Use) Order 1997 M77[F1316; F1317...]

[F1318(h)a product which is authorised by the licensing authority on a temporary basis under regulation 174, in circumstances where the licensing authority has attached a condition to that authorisation to the effect that, for the duration of the temporary authorisation, the product is classified as a prescription only medicine [F1319; and]]

[F1320(i)an EAMS medicinal product, in circumstances where the licensing authority has attached a condition to the EAMS scientific opinion in respect of that product to the effect that, for the duration of that opinion, the product is classified as a prescription only medicine.]

Textual Amendments

F1307Words in Sch. 1 para. 1(b) inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 10 and words in Sch. 1 para. 1(b) inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 10

Marginal Citations

2.  In this Part “cyanogenic substances” means preparations which—U.K.

(a)are presented for sale or supply under the name of, or as containing, amygdalin, laetrile or vitamin B17; or

(b)contain more than 0.1 per cent by weight of any substance having the formula either—

(i)alpha-Cyanobenzyl -6-O-Beta-d-glucopyranosyl -Beta-d-glucopyranoside, or

(ii)alpha-Cyanobenzyl -Beta-d-glucopyranosiduronic acid.

PART 2U.K.Descriptions of certain medicinal products to be available only from a pharmacy

3.  The following medicinal products shall be available only from a pharmacy—U.K.

(a)a product comprising eye ointment;

(b)a product that contains Vitamin A, Vitamin A acetate or Vitamin A palmitate, in each case with a maximum daily dose equivalent to more than 7500 international units of Vitamin A or 2250 micrograms of retinol;

(c)a product that contains Vitamin D with a maximum daily dose of more than 400 units of antirachitic activity [F1321; F1322...]

[F1323(d)a product which is authorised by the licensing authority on a temporary basis under regulation 174, in circumstances where the licensing authority has attached a condition to that authorisation to the effect that, for the duration of the temporary authorisation, it is only to be available from a pharmacy [F1324; and]]

[F1325(e)an EAMS medicinal product, in circumstances where the licensing authority has attached a condition to the EAMS scientific opinion in respect of that product to the effect that, for the duration of that opinion, it is only to be available from a pharmacy.]

Textual Amendments

4.  The following medicinal products shall be available only from a pharmacy unless they are the subject of a [F1326UK marketing authorisation F1327..., Article 126a authorisation, parallel import licence] or traditional herbal registration that classifies them as medicinal products subject to general sale—U.K.

(a)a product that is for use as an anthelmintic;

(b)a product that is for parenteral administration;

(c)a product that is for use as an enema;

(d)a product that is for use wholly or mainly for irrigation of—

(i)wounds, or

(ii)the bladder, vagina or rectum;

(e)a product that is for administration wholly or mainly to children being a preparation of aloxiprin or aspirin.

Textual Amendments

5.  A medicinal product shall be available only from a pharmacy if it is a medicinal product of a kind specified in Schedule 15 but is not presented for sale in accordance with the requirements specified in that Schedule for a product of that kind to be subject to general sale.U.K.

Regulation 16

SCHEDULE 2U.K.Supplementary provision relating to advisory bodies and expert advisory groups

Terms of appointmentU.K.

1.—(1) The person appointed to chair an advisory body is to hold and vacate office in accordance with the written terms of the appointment (but this is subject to sub-paragraphs (2) and (3)).U.K.

(2) The person's term of office as chair of the advisory body is not to exceed the person's term of office as a member of the body.

(3) The person may resign from chairing the advisory body at any time by notice in writing to the Ministers.

2.—(1) A member of an advisory body, other than its chair, is to hold and vacate office in accordance with the written terms of the appointment (but this is subject to sub-paragraphs (2) and (3)).U.K.

(2) The term of an appointment may not exceed four years (but an appointment may be renewed).

(3) A member of an advisory body may resign from it at any time by notice in writing to the Ministers.

(4) Where a person ceases to be a member of an advisory body, the person also ceases to be a member of any expert advisory group appointed by the advisory body (including an expert advisory group appointed jointly with the other advisory body).

(5) But sub-paragraph (4) does not apply if—

(a)the person was a member of the advisory body only by virtue of being co-opted under regulation 13; or

(b)the person is immediately re-appointed to the advisory body.

3.—(1) The person appointed to chair an expert advisory group is to hold and vacate office in accordance with the written terms of the appointment (but this is subject to sub-paragraphs (2) and (3)).U.K.

(2) The person's term of office as chair of the expert advisory group is not to exceed the person's term of office as a member of the group.

(3) The person may resign from chairing the group at any time by notice in writing to the advisory body or bodies which appointed the group.

4.—(1) This paragraph applies to a member of an expert advisory group, other than a person appointed to chair an expert advisory group.U.K.

(2) The member is to hold and vacate office in accordance with the written terms of the appointment (but this is subject to sub-paragraphs (3) and (4)).

(3) The term of an appointment may not exceed four years (but an appointment may be renewed).

(4) The member may resign office at any time by notice in writing to the advisory body or bodies which appointed the group.

Facilities and proceedingsU.K.

5.  The Ministers must provide each advisory body with such staff, accommodation, services and other facilities as the Ministers think necessary or expedient for the proper performance of its functions.U.K.

6.  The validity of any proceedings of an advisory body or expert advisory group is not affected by—U.K.

(a)a vacancy among its members; or

(b)a defect in the appointment of any member.

7.—(1) An advisory body may, subject to approval by the Secretary of State, make such provision as it thinks fit for the regulation of its own proceedings.U.K.

(2) The licensing authority may make provision for the regulation of the proceedings of an expert advisory group.

Payment and expensesU.K.

8.  The Ministers may pay to the members of each advisory body and expert advisory group such remuneration (if any) and such allowances as may be determined by the Ministers with the consent of the Treasury.U.K.

9.  The Ministers must defray any expenses incurred with their approval by each advisory body and expert advisory group.U.K.

10.  If an action is brought against a person arising out of an act performed as a member of an advisory body or expert advisory group, the Ministers may indemnify that person against any damages, costs or expenses incurred in that action.U.K.

11.  Paragraphs 8 to 10 shall have effect in relation to an expert committee appointed by the licensing authority and to its members as if they were an advisory body or expert advisory group and its members.U.K.

StatusU.K.

12.  An advisory body or expert advisory group is not to be regarded—U.K.

(a)as a servant or agent of the Crown; or

(b)as enjoying any status, immunity or privilege of the Crown.

Regulations 8(1) and B17(3)

[F1328SCHEDULE 2AU.K.Modifications of Commission Directive 2003/94/EC

Textual Amendments

Provision of Commission Directive 2003/94/ECModification subject to which that provision is to be read
Article 1 (scope)

The reference to—

(a) “Article 40 of Directive 2001/83/EC” is to be read as a reference to “regulation 17 of the Human Medicines Regulations 2012”; and

(b) “Article 13 of Directive 2001/20/EC” is to be read as a reference to “regulation 36 of the Medicines for Human Use (Clinical Trials) Regulations 2004”.

Article 2 (definitions)

In the definition of—

(a) “medicinal product”, the reference to “Article 1(2) of Directive 2001/83/EC” is to be read as a reference to “regulation 2 of the Human Medicines Regulations 2012”;

(b) “investigational medicinal product”, the reference to “Article 2(d) of Directive 2001/20/EC” is to be read as a reference to “regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004”;

(c) “manufacturer” the reference to “Article 40(1) and (3) of Directive 2001/83/EC or the authorisation referred to in Article 13(1) of Directive 2001/20/EC” is to be read as a reference to “regulation 17(1) of the Human Medicines Regulations 2012 or the authorisation referred to in regulation 36(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004”;

(d) “qualified person” the reference to “Article 48 of Directive 2001/83/EC or in Article 13(2) of Directive 2001/20/EC” is to be read as a reference to “regulation 41 of the Human Medicines Regulations 2012 or regulation 43 of the Medicines for Human Use (Clinical Trials) Regulations 2004”.

Article 3(1) (inspections)

The reference to—

(a) “for Article 111(1) of Directive 2001/83/EC” is to be read as a reference to “Part 16 of the Human Medicines Regulations 2012 (enforcement)”;

(b) “Article 15(1) of Directive 2001/20/EC” is to be read as a reference to “Part 8 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (enforcement)”;

(c) “the Member States”, is to be read as a reference to “the licensing authority”;

(d) “Member States shall” is to be read as a reference to “The licensing authority may”;

(e) “published by the Commission, of Community procedures on inspections and exchanges of information” is to be read as if after it there were inserted “or any guidance published by the licensing authority to replace that Commission guidance”.

Article 3(2) (inspections)

The reference to—

(a) “competent authorities” is to be read as a reference to “licensing authority”;

(b) “the second paragraph of Article 47 of Directive 2001/83/EC” to the end is to be read as a reference to “regulation C17(1)(a) of the Human Medicines Regulations 2012, or which applies by virtue of regulation C17(2) of those Regulations”.

Article 4(2) (conformity with good manufacturing practice)

The reference to—

(a) “third countries” is to be read as a reference to “country other than the United Kingdom”;

(b) “Community” is to be read as a reference to “licensing authority”.

Article 5 (compliance with marketing authorisation)

The reference to—

(a) “Article 9(2) of Directive 2001/20/EC” in both places it appears is to be read as a reference to “regulation 17 of the Medicines for Human Use (Clinical Trials) Regulations 2004”;

(b) “competent authorities” in both places it appears is to be read as a reference to “licensing authority”.

Article 9 (documentation)

The reference in—

(a) paragraph (1) to “Article 51(3) of Directive 2001/83/EC” is to be read as a reference to “paragraph 15(1) of Schedule 7 to the Human Medicines Regulations 2012”;

(b) paragraph (2) to “competent authorities” is to be read as a reference to “licensing authority”.

Article 11 (quality control)

The reference in paragraph (2)—

(a) to “point (b) of Article 20 of Directive 2001/83/EC” is to be read as a reference to “paragraph 3 or 17 of Schedule 4 to the Human Medicines Regulations 2012”;

(b) to “Article 9(2) of Directive 2001/20/EC” is to be read as a reference to “regulation 17 of the Medicines for Human Use (Clinical Trials) Regulations 2004”;

The reference in paragraph (4)—

(a) to “Member State” is to be read as a reference to “United Kingdom”;

(b) to “competent authority” is to be read as a reference to “licensing authority”;

Article 12(4) (work contracted out)

The reference to—

(a) “competent authorities” is to be read as a reference to “licensing authority”;

(b) “for Article 111 of Directive 2001/83/EC and Article 15(1) of Directive 2001/20/EC” is to be read as a reference to “Part 16 of the Human Medicines Regulations 2012 or Part 8 of the Medicines for Human Use (Clinical Trials) Regulations 2004”.

Article 13 (complaints, product recall and emergency unblinding)The reference to “Article 123 of Directive 2001/83/EC” is to be read as a reference to “Part 5 of the Human Medicines Regulations 2012”.]

Regulation 21(1)

SCHEDULE 3U.K.Applications for licences under Part 3

Manufacturer's licencesU.K.

1.—(1) This paragraph applies to an application for a manufacturer's licence relating to the manufacture or assembly of medicinal products.U.K.

(2) The application must contain—

(a)the name and address of the applicant;

(b)the name and address of the person (if any) making the application on the applicant's behalf;

(c)[F1329except where the operations will relate to an MM medicinal product or a POC medicinal product,] the address of each of the premises where any operations to which the licence relates are to be carried out;

[F1330(ca)where the application relates to an MM medicinal product, the address of the MM control site;

(cb)where the application relates to a POC medicinal product, the address of the POC control site;]

(d)the address of any premises not mentioned by virtue of paragraph (c) [F1331, (ca) or (cb)] where—

(i)the applicant proposes to keep any living animals, from which a substance used in the production of the medicinal product to which the application relates is to be derived, or

(ii)materials of animal origin, from which a substance is to be derived as mentioned in sub-paragraph (i), are to be kept;

(e)the address of each of the premises where medicinal products are to be stored, or from which medicinal products are to be distributed;

(f)the name, address, qualifications and experience of the person (“S”) whose duty it will be to supervise the manufacturing or assembling operations, and the name and job title of the person to whom S reports;

[F1332(g)the name, address, qualifications and experience of the person with responsibility for quality control in relation to the medicinal products to be manufactured or assembled under the licence (and, if that responsibility is to be carried out by the holder of—

(i)in the case of a product for sale or supply in Great Britain, the UK marketing authorisation, certificate of registration or traditional herbal registration relating to the products, or

(ii)in the case of a product for sale or supply in Northern Ireland, the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to the products,

a statement of that fact);]

(h)the name, address and qualifications of the person to be responsible for any animals kept as mentioned in sub-paragraph (d)(i);

(i)the name, address and qualifications of the person to be responsible for the culture of any living tissue for use in the manufacture of medicinal products;

(j)the name, address and qualifications of the qualified person.

(3) The application must also contain—

(a)the pharmaceutical form of each medicinal product to be manufactured or assembled;

(b)details of the manufacturing or assembling operations to which the licence is to relate, including a statement of whether they include—

(i)the manufacture of medicinal products, or

(ii)the assembly of medicinal products;

[F1333(ba)a statement of whether any of the medicinal products to be manufactured or assembled are MM medicinal products or POC medicinal products;]

(c)a statement of whether the medicinal products are to be manufactured or assembled for the purpose of—

(i)being administered to human beings in that form, or

(ii)as an ingredient in the preparation of another medicinal product;

(d)a statement of the facilities and equipment available at each of the premises where medicinal products are to be stored, or from which medicinal products are to be distributed;

(e)a separate statement, in respect of each of the premises mentioned in the application, of—

(i)the manufacturing or assembling operations capable of being carried out at those premises, and the class of medicinal products to which those operations relate, and

(ii)the equipment available at those premises for carrying out each stage of those operations;

(f)a statement of the authority conferred on the person mentioned in sub-paragraph (2)(g) to reject unsatisfactory medicinal products;

(g)a description of the arrangements for the identification and storage of materials and ingredients before and during manufacture or assembly and for the storage of medicinal products after manufacture or assembly;

(h)a description of the arrangements, at each of the premises where the applicant proposes to store medicinal products, for ensuring, so far as practicable, the turn-over of stocks of medicinal products;

(i)a description of the arrangements for maintaining—

(i)production records, and

(ii)records of analytical and other tests used in the course of manufacture or assembly for ensuring compliance of materials used in manufacture, or of medicinal products, with the specification for such materials or medicinal products;

(j)a description of the arrangements for keeping reference samples of—

(i)materials used in the manufacture of medicinal products, and

(ii)medicinal products;

(k)where the application relates to an exempt advanced therapy medicinal product, an outline of the arrangements for maintaining records to allow product traceability containing sufficient detail to enable the linking of a product to the patient who received it and vice versa; and

(l)details of—

(i)any manufacturing operations, other than those to which the licence is to relate, carried on by the proposed licence holder on or near the premises mentioned in sub-paragraph (2)(c), and

(ii)the substances or articles to which those operations relate.

Textual Amendments

[F1334Manufacturer’s licences (MM)U.K.

Textual Amendments

1A.—(1) This paragraph applies to an application for a manufacturer’s licence relating to MM medicinal products.U.K.

(2) In addition to the requirements in paragraph 1, the application must be accompanied by a dossier for each MM medicinal product to which the application relates, which includes, as a minimum, the following—

(a)a description and means of identification of each modular unit at which manufacture or assembly of the MM medicinal product is to take place;

(b)the location of each unit at which manufacturing or assembly of the MM medicinal product is to take place;

(c)the location of each site at which operations related to the manufacture or assembly of the MM medicinal product are to take place;

(d)a description of the process by which the licence holder will approve new modular units;

(e)a description of the processes by which the licence holder will initiate, suspend and cease manufacturing or assembly of the product at a modular unit;

(f)a description of the manufacturing, assembly and product release processes to take place at each modular unit;

(g)a description of the arrangements for supervision and control by the licence holder of the manufacture or assembly operations at each modular unit;

(h)a description of the arrangements for reporting of suspected adverse reactions from modular units to the MM control site;

(i)the name and contact details of the person at the MM control site who is to be contacted in respect of manufacturing or assembly operations under the licence;

(j)the name and contact details of the person to be contacted in respect of manufacturing or assembly operations at each modular unit;

(k)the name and contact details of the person at the MM control site who is to be contacted in respect of quality operations under the licence;

(l)the name and contact details of the person to be contacted in respect of quality operations at each modular unit; and

(m)a description of the processes by which the licence holder will review and amend the MM master file for the product.

Manufacturer’s licence (POC)U.K.

1B.—(1) This paragraph applies to an application for a manufacturer’s licence relating to POC medicinal products.U.K.

(2) In addition to the requirements in paragraph 1, the application must be accompanied by a dossier for each POC medicinal product to which the application relates, which includes, as a minimum, the following—

(a)the location of each site at which manufacturing or assembly of the POC medicinal product is to take place;

(b)the location of each site at which operations related to the manufacture or assembly of the POC medicinal product are to take place;

(c)a description of the process by which the licence holder will approve new POC sites;

(d)a description of the processes by which the licence holder will suspend and cease manufacturing or assembly of the POC medicinal product at a POC site;

(e)a description of the manufacturing, assembly and product release processes to take place at each POC site;

(f)a description of the arrangements for supervision and control by the licence holder of the manufacture or assembly operations at each POC site;

(g)a description of the arrangements for reporting of suspected adverse reactions from POC sites to the POC control site;

(h)the name and contact details of the person at the POC control site who is to be contacted in respect of manufacturing or assembly operations under the licence;

(i)the name and contact details of the person to be contacted in respect of manufacturing or assembly operations at each POC site;

(j)the name and contact details of the person at the POC control site who is to be contacted in respect of quality operations under the licence;

(k)the name and contact details of the person who is to be contacted in respect of quality operations at each POC site; and

(l)a description of the processes by which the licence holder will review and amend the POC master file for the product.]

Manufacturers' licence relating to importU.K.

2.—[F1335(1) This paragraph applies to an application for a manufacturer's licence relating to the import from—U.K.

(a)in the case of an import into Great Britain, a country other than Northern Ireland or a country other than an approved country for import, or

(b)in the case of an import into Northern Ireland, a country other than an EEA State,

of medicinal products.]

(2) The application must contain—

(a)the name and address of the applicant;

(b)the name and address of the person (if any) making the application on the applicant's behalf;

(c)the name, pharmaceutical form, country of origin and marketing authorisation number of each imported medicinal product;

(d)the address of each set of premises where the importation operation is to take place;

(e)the address of each set of premises where any testing associated with the importation is to take place;

(f)the address of each set of premises where medicinal products are to be stored, or from which they are to be distributed;

(g)the name, address and qualifications of the qualified person; and

(h)the name, address, qualifications and experience of the person in charge of quality control.

(3) The application must also contain—

(a)details of the importation operations to which the licence is to relate;

(b)a statement of the facilities and equipment available at each set of premises where medicinal products are to be stored, or from which they are to be distributed;

(c)details of—

(i)any manufacturing of medicinal products carried on by the applicant on or near the premises mentioned in sub-paragraph (2)(d) to (f), and

(ii)the substances or articles manufactured or used in the manufacturing;

(d)a description of the arrangements for storage of the medicinal products after importation;

(e)a description of the arrangements at each set of premises for ensuring, so far as practicable, the turn-over of stocks of medicinal products;

(f)a description of the arrangements for maintaining—

(i)records of importation, and

(ii)records of analytical and other procedures applied in the course of importation; and

(g)a description of the arrangements for keeping reference samples of the medicinal products.

Textual Amendments

Wholesale dealer's licencesU.K.

3.—(1) This paragraph applies to an application for a wholesale dealer's licence.U.K.

(2) The application must contain—

(a)the name and address of the applicant;

(b)the name and address of the person (if any) making the application on the applicant's behalf;

(c)the address of each of the premises where medicinal products are to be stored, or from which they are to be distributed; and

(d)the name, address and qualifications of the responsible person [F1336or the responsible person (import)].

(3) The application must also contain—

(a)details of the distribution by way of wholesale dealing to which the licence is to relate;

(b)a statement of whether the medicinal products to which the distribution relates are the subject of—

[F1337(i)in the case of a product for sale or supply in Great Britain, a UK marketing authorisation,

(ia)in the case of a product for sale or supply in Northern Ireland, a marketing authorisation,]

(ii)a certificate of registration,

(iii)a traditional herbal registration, or

(iv)[F1338in the case of a product for sale or supply in Northern Ireland,] an Article 126a authorisation;

[F1339(v)an authorisation granted by an authority in a country other than the United Kingdom to sell or supply the medicinal product in that other country;]

(c)a statement of whether the medicinal products to which the distribution relates are—

(i)prescription only medicines,

(ii)pharmacy medicines, or

(iii)medicines subject to general sale;

(d)a statement of whether the medicinal products to which the distribution relates are—

(i)special medicinal products, F1340...

[F1341(ia)EAMS medicinal products,]

(ii)sold or supplied pursuant to regulation 174 (supply in response to spread of pathogenic agents [F1342etc), or]

[F1343(iii)to be distributed by means of export from Great Britain to an approved country for import;]

(e)a statement of whether the medicinal products dealt in under the licence are to be used—

(i)for administration to human beings, or

(ii)as ingredients in the preparation of medicinal products for administration to human beings;

(f)an indication of the range of medicinal products to be stored at each of the premises mentioned in the application;

(g)a statement of the facilities and equipment available at those premises for storing and distributing medicinal products;

(h)a description of the arrangements at those premises for ensuring, so far as practicable, the turn-over of stocks of medicinal products (whether by the maintenance of records or by other means);

(i)details of an emergency plan which satisfies the requirements of regulation 43(7)(b), and

(j)a description of the arrangements for keeping records relating to products received or dispatched.

[F1344(4) In sub-paragraph (2)(d)—

“the responsible person” means the person who has the functions described in regulation 45(2);

“the responsible person (import)” means the person who has the functions described in regulation 45AA(4).]

Textual Amendments

F1337Sch. 3 para. 3(3)(b)(i)(ia) substituted for Sch. 3 para. 3(3)(b)(i) by S.I. 2019/775, regs. 1, 18(4)(b)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 12(c)(i))

All licencesU.K.

4.—(1) If an application does not include information or other matters required under this Schedule, the application must state—U.K.

(a)why that information is not applicable; or

(b)any other reason for not including them.

(2) An application for a licence must be in English.

(3) The pages of an application for a licence must be serially numbered.

(4) The applicant must sign the application.

(5) If the application is made by another person on behalf of the applicant, that person must also sign the application.

Regulation 24

SCHEDULE 4U.K.Standard provisions of licences under Part 3

PART 1U.K.Manufacturer's licence relating to manufacture and assembly

1.  The provisions of this Part are standard provisions of a manufacturer's licence relating to the manufacture or assembly of medicinal products.U.K.

2.  The licence holder must place the quality control system referred to in Article 11(1) of the Good Manufacturing Practice Directive under the authority of the person notified to the licensing authority in accordance with paragraph 1(2)(g) of Schedule 3.U.K.

3.  The licence holder may use a contract laboratory pursuant to Article 11(2) of the Good Manufacturing Practice Directive if the laboratory is operated by a person approved by the licensing authority.U.K.

4.  The licence holder must provide such information as may be requested by the licensing authority—U.K.

(a)about the products currently being manufactured or assembled by the licence holder; and

(b)about the operations being carried out in relation to such manufacture or assembly.

5.  The licence holder must inform the licensing authority of any change that the licence holder proposes to make to a person named in the licence as—U.K.

(a)the person whose duty it is to supervise the manufacturing or assembling operations;

(b)in charge of the animals from which are derived substances used in the production of the medicinal products being manufactured or assembled; or

(c)responsible for the culture of living tissues used in the manufacture of the medicinal products being manufactured or assembled.

6.  The licence holder must—U.K.

(a)keep readily available for inspection by a person authorised by the licensing authority the batch documentation referred to in Article 9(1) of the Good Manufacturing Practice Directive; and

(b)permit the authorised person to take copies or make extracts from such documentation.

7.  The licence holder must keep readily available for examination by a person authorised by the licensing authority the samples in each batch of finished medicinal product referred to in Article 11(4) of the Good Manufacturing Practice Directive.U.K.

8.  Where the licence holder has been informed by the licensing authority that the strength, quality or purity of a batch of a medicinal product to which the licence relates has been found not to conform with—U.K.

(a)the specification for the finished product; or

(b)the provisions of these Regulations applicable to the medicinal product,

the holder must, if so directed, withhold the batch from distribution, so far as reasonably practicable, for a period (not exceeding six weeks) specified by the licensing authority.

9.  The licence holder must ensure that tests for determining conformity with the standards and specifications applying to a product used in the manufacture of a medicinal product must, except so far as the conditions of the product specification for that product otherwise provide, be applied to samples taken from the medicinal product after all manufacturing processes have been completed, or at such earlier stage of the manufacture as may be approved by the licensing authority.U.K.

10.  Where the manufacturer's licence relates to the assembly of a medicinal product or class of product, and the licence holder supplies the product at such a stage of assembly that does not fully comply with the provisions of the product specification which relate to labelling, the licence holder must communicate the particulars of those provisions to the person to whom that product has been supplied.U.K.

11.  Where—U.K.

(a)the manufacturer's licence relates to the assembly of a medicinal product;

(b)the medicinal product is not manufactured by the licence holder; and

(c)particulars of the name and address of the manufacturer of the product, or the person who imports the product, have been given by the licence holder to the licensing authority,

the licence holder must immediately notify the licensing authority in writing of any changes in the particulars.

12.  The licence holder must keep readily available for examination by a person authorised by the licensing authority durable records of the details of the manufacture of intermediate products held by the licence holder for use in the manufacture of biological medicinal products, and the records must—U.K.

(a)be in such form as to ensure that the licence holder has a comprehensive record of all matters that are relevant to an evaluation of the safety, quality and efficacy of a finished biological medicinal product manufactured using those intermediate products; and

(b)not be destroyed without the consent of the licensing authority until the records of the details of manufacture of finished medicinal products which were or may be manufactured using those intermediate products may be destroyed in accordance with the requirements of these Regulations.

13.  Where—U.K.

(a)animals are used in the production of medicinal products; and

[F1345(b)in the case of a product for sale or supply—

(i)in Great Britain, a UK marketing authorisation, certificate of registration or traditional herbal registration, or

(ii)in Northern Ireland, a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration,

contains provisions relating to them,]

the manufacturer's licence holder must arrange for the animals to be housed in such premises, and managed in such a manner, as facilitates compliance with those provisions.

Textual Amendments

14.  The licence holder must take all reasonable precautions and exercise all due diligence to ensure that any information provided to the licensing authority is not false or misleading in any material particular if—U.K.

(a)it relates to a medicinal product which the licence holder manufactures or assembles; or

(b)it relates to any starting materials or intermediate products held by the licence holder which are for use in the manufacture of medicinal products.

[F134614A.  A licence holder—U.K.

(a)in Great Britain may only supply a special medicinal product to a person in Northern Ireland, and

(b)in Northern Ireland may only supply a special medicinal product to a person in Great Britain,

in response to an order which satisfies the requirements of regulation 167.]

Textual Amendments

[F134714B.  A licence holder may only manufacture or assemble EAMS medicinal products if and to the extent that such products are required for the Early Access to Medicines Scheme.]U.K.

Textual Amendments

[F1348Part 1AU.K.Manufacturer’s licence (MM)

Textual Amendments

14C.  The provisions of paragraphs 14D to 14K are incorporated as additional standard provisions of a manufacturer’s licence (MM).U.K.

14D.  The licence holder must maintain an MM master file for each MM medicinal product specified in the licence.U.K.

14E.  An MM master file may relate to one MM medicinal product only.U.K.

14F.  An MM master file must contain, as a minimum, the following information—U.K.

(a)the information specified in paragraph 1A(2) of Schedule 3; and

(b)the location and identification of any modular unit at which manufacturing or assembly of the MM medicinal product has commenced, has been suspended or has ceased, the date on which manufacturing or assembly commenced or ceased, and the dates on which it was suspended.

14G.  The licence holder must ensure that the information contained in the MM master file is kept up to date, and consistent with any UK marketing authorisation for the product, at all times.U.K.

14H.  The licence holder must make the MM master file available to the licensing authority at all times on request.U.K.

14I.  The licence holder must submit to the licensing authority, at annual intervals, an update of any changes to the MM master file made in the previous 12 month period, the first update being required to be submitted no later than the date that is 12 months from the date on which the manufacturer’s licence (MM) was granted.U.K.

14J.  The licence holder must keep under review the arrangements for supervision and control of the manufacture or assembly operations at each modular unit and, if the arrangements are found to be inadequate, ensure that appropriate remedial action is taken as soon as reasonably practicable.U.K.

14K.—(1) The licence holder must record all suspected adverse reactions to the MM medicinal product which are brought to the licence holder’s attention.U.K.

(2) The licence holder must not refuse to consider reports of suspected adverse reactions to the product received electronically or by any other appropriate means from patients or from health care professionals.

(3) The licence holder must report suspected adverse reactions identified under sub-paragraph (1) to the holder of the UK marketing authorisation, or the EAMS scientific opinion holder (as applicable), relating to the MM medicinal product as soon as reasonably practicable after the licence holder gains knowledge of the reaction.

Part 1BU.K. Manufacturer’s Licence (POC)

14L.  The provisions of paragraphs 14M to 14T are incorporated as additional standard provisions of a manufacturer’s licence (POC).U.K.

14M.  The licence holder must maintain a POC master file for each POC medicinal product specified in the licence.U.K.

14N.  A POC master file may relate to one POC medicinal product only.U.K.

14O.  A POC master file must contain, as a minimum, the following information:U.K.

(a)the information specified in paragraph 1B(2) of Schedule 3; and

(b)the location of any POC sites at which manufacturing or assembly of the POC medicinal product has commenced, has been suspended or has ceased, the date on which manufacturing or assembly commenced or ceased, and the dates on which it was suspended.

14P.  The licence holder must ensure that the information contained in the POC master file is kept up to date, and consistent with any UK marketing authorisation for the product, at all times.U.K.

14Q.  The licence holder must make the POC master file available to the licensing authority at all times on request.U.K.

14R.  The licence holder must submit to the licensing authority, at annual intervals, an update of any changes to the POC master file made in the previous 12 month period, the first update being required to be submitted no later than the date that is 12 months from the date on which the manufacturer’s licence (POC) was granted.U.K.

14S.  The licence holder must keep under review the arrangements for supervision and control of the manufacture or assembly operations at each POC site and, if the arrangements are found to be inadequate, ensure that appropriate remedial action is taken as soon as reasonably practicable.U.K.

14T.—(1) The licence holder must record all suspected adverse reactions to the POC medicinal product which are brought to the licence holder’s attention.U.K.

(2) The licence holder must not refuse to consider reports of suspected adverse reactions to the product received electronically or by any other appropriate means from patients or from health care professionals.

(3) The licence holder must report suspected adverse reactions identified under sub-paragraph (1) to the holder of any UK marketing authorisation, or the EAMS scientific opinion holder (as applicable), relating to the POC medicinal product as soon as reasonably practicable after the licence holder gains knowledge of the reaction.]

PART 2U.K.Manufacturer's licence relating to the import of medicinal products from a state other than an EEA State [F1349/ Country other than an Approved Country for Import]

Textual Amendments

15.  The provisions of this Part are standard provisions of a manufacturer's licence relating to the import of medicinal products [F1350from—U.K.

(a)in the case of an import into Great Britain, a country other than Northern Ireland or a country other than an approved country for import, or

(b)in the case of an import into Northern Ireland, a country other than an EEA State].

Textual Amendments

F1350Sch. 4 para. 15(a)(b) substituted for words in Sch. 4 para. 15 (31.12.2020) by S.I. 2019/775, reg. 20(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(d))

[F135115A.  The provisions of this Part are standard provisions of a manufacturer’s licence relating to the supply of a listed NIMAR product from Great Britain to Northern Ireland.]U.K.

Textual Amendments

16.  The licence holder must place the quality control system referred to in Article 11(1) of the Good Manufacturing Practice Directive under the authority of the person notified to the licensing authority in accordance with paragraph 2(2)(h) of Schedule 3.U.K.

17.  The licence holder may use a contract laboratory pursuant to Article 11(2) of the Good Manufacturing Practice Directive if operated by a person approved by the licensing authority.U.K.

18.  The licence holder must provide such information as may be requested by the licensing authority concerning the type and quantity of any medicinal products which the licence holder imports.U.K.

19.  The licence holder must—U.K.

(a)keep readily available for inspection by a person authorised by the licensing authority the batch documentation referred to in Article 9(1) of the Good Manufacturing Practice Directive; and

(b)permit the person authorised to take copies or make extracts from such documentation.

20.  Where the licence holder has been informed by the licensing authority that the strength, quality or purity of a batch of a medicinal product to which the licence relates has been found not to conform with—U.K.

(a)the specification of the medicinal product in question; or

(b)those provisions of these Regulations that are applicable to the medicinal product,

the licence holder must, if so directed, withhold the batch from distribution, so far as reasonably practicable, for such a period (not exceeding six weeks) as may be specified by the licensing authority.

21.  The licence holder must ensure that any tests for determining conformity with the standards and specifications applying to any ingredient used in the manufacture of a medicinal product must, except so far as the conditions of the product specification for that ingredient otherwise provide, be applied to samples taken from the medicinal product after all manufacturing processes have been completed, or at such earlier stage in the manufacture as may be approved by the licensing authority.U.K.

22.—(1) Where and in so far as the licence relates to special medicinal products, the licence holder may only import such products from [F1352, in the case of an import into Great Britain, a country other than Northern Ireland or a country other than an approved country for import and in the case of an import into Northern Ireland, a country other than an EEA State]—U.K.

(a)in response to an order which satisfies the requirements of regulation 167 (supply to fulfil special patient needs); and

(b)where the conditions set out in sub-paragraphs (2) to (9) are complied with.

(2) No later than 28 days before the day on which each importation of a special medicinal product takes place, the licence holder must give written notice to the licensing authority stating the intention to import the product and stating the following particulars—

(a)the brand name, common name or scientific name of the medicinal product and (if different) any name under which the medicinal product is to be sold or supplied in the United Kingdom;

(b)any trademark or the name of the manufacturer of the medicinal product;

(c)in respect of each active constituent of the medicinal product, any international non-proprietary name or the British approved name or the monograph name, or where that constituent does not have any of those, the accepted scientific name or any other name descriptive of the true nature of the constituent;

(d)the quantity of medicinal product to be imported, which must not exceed the quantity specified in sub-paragraph (6); and

(e)the name and address of the manufacturer or assembler of the medicinal product in the form in which it is to be imported and, if the person who will supply the medicinal product for importation is not the manufacturer or assembler, the name and address of the supplier.

(3) The licence holder may not import the special medicinal product if, before the end of 28 days beginning immediately after the date on which the licensing authority sends or gives the licence holder an acknowledgement in writing by the licensing authority that it has received the notice referred to in sub-paragraph (2), the licensing authority has notified the licence holder in writing that the product should not be imported.

(4) The licence holder may import the special medicinal product referred to in the notice where the licence holder has been notified in writing by the licensing authority, before the end of the 28-day period referred to in sub-paragraph (3) that the product may be imported.

(5) Where the licence holder sells or supplies special medicinal products [F1353or EAMS medicinal products], the licence holder must, in addition to any other records which are required by the provisions of the licence, make and maintain written records relating to—

(a)the batch number of the batch of the product from which the sale or supply was made; and

(b)details of any adverse reaction to the product sold or supplied of which the licence holder becomes aware.

(6) The licence holder must not, on any one occasion, import more than such amount as is sufficient for 25 single administrations, or for 25 courses of treatment where the amount imported is sufficient for a maximum of three months' treatment, and must not, on any one occasion, import more than the quantity notified to the licensing authority under sub-paragraph (2)(d).

(7) The licence holder must not publish any advertisement, catalogue or circular relating to a special medicinal product [F1354or EAMS medicinal product] or make any representations in respect of that product.

(8) The licence holder must inform the licensing authority immediately of any matter coming to the licence holder's attention which might reasonably cause the licensing authority to believe that a special medicinal product [F1355or EAMS medicinal product] imported in accordance with this paragraph can no longer be regarded as a product which can safely be administered to human beings or as a product which is of satisfactory quality for such administration.

(9) The licence holder must cease importing or supplying a special medicinal product [F1356or EAMS medicinal product] if the licence holder receives a notice in writing from the licensing authority directing that, from a date specified in the notice, a particular product or class of products may no longer be imported or supplied.

(10) In this paragraph—

“British approved name” means the name which appears in the current edition of the list prepared by the British Pharmacopoeia Commission under regulation 318 (British Pharmacopoeia: lists of names);

“international non-proprietary name” means a name which has been selected by the World Health Organisation as a recommended international non-proprietary name and in respect of which the Director-General of the World Health Organisation has given notice to that effect in the World Health Organisation Chronicle; and

“monograph name” means the name or approved synonym which appears at the head of a monograph in the current edition of the British Pharmacopoeia, the European Pharmacopoeia or a foreign or international compendium of standards and “current” in this definition means current at the time the notice is sent to the licensing authority.

Textual Amendments

23.  The licence holder must take all reasonable precautions and exercise due diligence to ensure that any information provided to the licensing authority which is relevant to an evaluation of the safety, quality or efficacy of a medicinal product for human use which is imported from [F1357, in the case of an import into Great Britain, a country other than Northern Ireland or a country other than an approved country for import and in the case of an import into Northern Ireland, a country other than an EEA State], handled, stored or distributed under the licence is not false or misleading in a material particular.U.K.

Textual Amendments

[F135823ZA.  The licence holder in Great Britain must take all reasonable precautions and exercise due diligence to ensure that any information provided to the licensing authority which is relevant to an evaluation of the safety, quality or efficacy of a product for human use which is supplied from Great Britain into Northern Ireland by virtue of regulation 167A handled, stored or distributed under the licence is not false or misleading in a material particular.]U.K.

Textual Amendments

[F135923A.  A licence holder—U.K.

(a)in Great Britain may only supply a special medicinal product to a person in Northern Ireland, and

(b)in Northern Ireland may only supply a special medicinal product to a person in Great Britain,

in response to an order which satisfies the requirements of regulation 167.]

Textual Amendments

[F136023B.  A licence holder may only import EAMS medicinal products if and to the extent that such products are required for the Early Access to Medicines Scheme.]U.K.

Textual Amendments

PART 3U.K.Manufacturer's licence relating to exempt advanced therapy medicinal products

24.  The provisions of paragraphs 25 to 27 are incorporated as additional standard provisions of a manufacturer's licence relating to the manufacture and assembly of exempt advanced therapy medicinal products.U.K.

25.  The licence holder must ensure that the immediate packaging of an exempt advanced therapy medicinal product is labelled to show the following particulars—U.K.

(a)the name of the exempt advanced therapy medicinal product;

(b)the expiry date in clear terms including the year and month and, if applicable, the day;

(c)a description of the active substance, expressed qualitatively and quantitatively;

(d)where the product contains cells or tissues of human or animal origin—

(i)a statement that the product contains such cells or tissues, and

(ii)a short description of the cells or tissues and of their specific origin;

(e)the pharmaceutical form and the contents by weight, volume or number of doses of the product;

(f)a list of excipients, including preservative systems;

(g)the method of use, application, administration or implantation and, if appropriate, the route of administration, with space provided for the prescribed dose to be indicated;

(h)any special storage precautions;

(i)specific precautions relating to the disposal of the unused product or waste derived from the product and, where appropriate, reference to any appropriate collection system;

(j)the name and address of the holder of the manufacturer's licence;

(k)the manufacturer's licence number;

(l)the manufacturer's batch number;

(m)the unique donation code [F1361assigned by a tissue establishment pursuant to—

(a)paragraph 1 of Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards human gametes and embryos; and

(b)paragraph 1 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other human tissues and cells]; and

(n)where the exempt advanced therapy medicinal product is for autologous use, the unique patient identifier and the words “for autologous use only”.

Textual Amendments

26.  The licence holder must ensure that the package leaflet of the exempt advanced therapy medicinal product shall include the following particulars—U.K.

(a)the name of the exempt advanced therapy medicinal product;

(b)the intended effect of the medicinal product if correctly used, applied, administered or implanted;

(c)where the product contains cells or tissues of human or animal origin—

(i)a statement that the product contains such cells or tissues, and

(ii)a short description of the cells or tissues and, where such cells or tissues are of animal origin, their specific origin;

(d)where the product contains a medical device or an active implantable medical device, a description of that device and, where that device contains cells or tissues of animal origin, their specific origin;

(e)any necessary instructions for use, including—

(i)the posology,

(ii)the method of use, application, administration or implantation and, if appropriate, the route of administration,

(iii)a description of symptoms of overdose,

(iv)action to be taken in the event of overdose, including any emergency procedures,

(v)action to be taken if one or more doses have been missed, and

(vi)a recommendation to consult the doctor or pharmacist for any clarification on the use of the product;

(f)where adverse reactions are known, a description of those which may occur under recommended conditions of use of the product and, if appropriate, an indication of action to be taken in such a case;

(g)an instruction that the patient report any adverse reaction not specified in the package leaflet to the doctor or pharmacist;

(h)the expiry date in clear terms and a warning against using the product after that date;

(i)any special storage precautions;

(j)a description of any visible signs of deterioration;

(k)a complete qualitative and quantitative composition;

(l)the name and address of the holder of the manufacturer's licence; and

(m)the date on which the package leaflet was last revised.

27.  The licence holder must keep the data referred to in paragraph 8 of Schedule 6 for such period, being a period of longer than 30 years, as may be specified by the licensing authority.U.K.

PART 4U.K.Wholesale dealer's licence

All wholesale dealer's licencesU.K.

28.  The provisions of this Part are standard provisions of a wholesale dealer's licence.U.K.

29.  The licence holder must not use any premises for the handling, storage or distribution of medicinal products other than those specified in the licence or notified to the licensing authority from time to time and approved by the licensing authority.U.K.

30.  The licence holder must provide such information as may be requested by the licensing authority concerning the type and quantity of medicinal products which the licence holder handles, stores or distributes.U.K.

31.  The licence holder must take all reasonable precautions and exercise all due diligence to ensure that any information provided by the licence holder to the licensing authority which is relevant to an evaluation of the safety, quality or efficacy of a medicinal product which the licence holder handles, stores or distributes is not false or misleading.U.K.

Wholesale dealer's licence relating to special medicinal productsU.K.

32.  The provisions of paragraphs 33 to 42 are incorporated as additional standard provisions of a wholesale dealer's licence relating to special medicinal products.U.K.

33.  Where and in so far as the licence relates to special medicinal products, the licence holder may only import such products from [F1362, in the case of an import into Great Britain, an approved country for import and in the case of an import into Northern Ireland, an EEA State]—U.K.

(a)in response to an order which satisfies the requirements of regulation 167, and

(b)where the conditions set out in paragraphs 34 to 41 are complied with.

Textual Amendments

[F136333A.  A licence holder may only import EAMS medicinal products if and to the extent that such products are required for the Early Access to Medicines Scheme.]U.K.

Textual Amendments

34.  No later than 28 days prior to each importation of a special medicinal product, the licence holder must give written notice to the licensing authority stating the intention to import the product and stating the following particulars—U.K.

(a)the brand name, common name or scientific name of the medicinal product and (if different) any name under which the medicinal product is to be sold or supplied in the United Kingdom;

(b)any trademark or the name of the manufacturer of the medicinal product;

(c)in respect of each active constituent of the medicinal product, any international non-proprietary name or the British approved name or the monograph name, or where that constituent does not have any of those, the accepted scientific name or any other name descriptive of the true nature of the constituent;

(d)the quantity of medicinal product to be imported, which must not exceed the quantity specified in paragraph 38; and

(e)the name and address of the manufacturer or assembler of the medicinal product in the form in which it is to be imported and, if the person who will supply the medicinal product for importation is not the manufacturer or assembler, the name and address of the supplier.

35.  The licence holder may not import the special medicinal product if, before the end of 28 days beginning immediately after the date on which the licensing authority sends or gives the licence holder an acknowledgement in writing by the licensing authority that it has received the notice referred to in paragraph 34, the licensing authority has notified the licence holder in writing that the product should not be imported.U.K.

36.  The licence holder may import the special medicinal product referred to in the notice where the licence holder has been notified in writing by the licensing authority, before the end of the 28-day period referred to in paragraph 35, that the product may be imported.U.K.

37.  Where the licence holder sells or supplies special medicinal products [F1364or EAMS medicinal products], the licence holder must, in addition to any other records which are required by the provisions of the licence, make and maintain written records relating to—U.K.

(a)the batch number of the batch of the product from which the sale or supply was made; and

(b)details of any adverse reaction to the product sold or supplied of which the licence holder becomes aware.

Textual Amendments

38.  The licence holder must not, on any one occasion, import more than such amount as is sufficient for 25 single administrations, or for 25 courses of treatment where the amount imported is sufficient for a maximum of three months' treatment, and must not, on any one occasion, import more than the quantity notified to the licensing authority under paragraph 34(d).U.K.

39.  The licence holder must inform the licensing authority immediately of any matter coming to the licence holder's attention which might reasonably cause the licensing authority to believe that a special medicinal product [F1365or EAMS medicinal product] imported in accordance with this paragraph can no longer be regarded as a product which can safely be administered to human beings or as a product which is of satisfactory quality for such administration.U.K.

Textual Amendments

40.  The licence holder must not publish any advertisement, catalogue, or circular relating to a special medicinal product [F1366or EAMS medicinal product] or make any representations in respect of that product.U.K.

Textual Amendments

41.  The licence holder must cease importing or supplying a special medicinal product [F1367or EAMS medicinal product] if the licence holder receives a notice in writing from the licensing authority directing that, from a date specified in the notice, a particular product or class of products may no longer be imported or supplied.U.K.

Textual Amendments

[F136841A.  A licence holder—U.K.

(a)in Great Britain may only supply a special medicinal product to a person in Northern Ireland, and

(b)in Northern Ireland may only supply a special medicinal product to a person in Great Britain,

in response to an order which satisfies the requirements of regulation 167.]

Textual Amendments

42.  In this Part—U.K.

“British approved name” means the name which appears in the current edition of the list prepared by the British Pharmacopoeia Commission under regulation 318 (British Pharmacopoeia- lists of names);

“international non-proprietary name” means a name which has been selected by the World Health Organisation as a recommended international non-proprietary name and in respect of which the Director-General of the World Health Organisation has given notice to that effect in the World Health Organisation Chronicle; and

“monograph name” means the name or approved synonym which appears at the head of a monograph in the current edition of the British Pharmacopoeia, the European Pharmacopoeia or a foreign or international compendium of standards, and “current” in this definition means current at the time the notice is sent to the licensing authority.

Wholesale dealer's licence relating to exempt advanced therapy medicinal productsU.K.

43.  The provisions of paragraph 44 are incorporated as additional standard provisions of a wholesale dealer's licence relating to exempt advanced therapy medicinal products.U.K.

44.  The licence holder shall keep the data referred to in paragraph 16 of Schedule 6 for such period, being a period of longer than 30 years, as may be specified by the licensing authority.U.K.

Regulation 27; Schedule 11paragraphs 11(3), 13(3),23(4) and 30(4)

SCHEDULE 5U.K.Review upon oral representations

Application of this ScheduleU.K.

[F13691.—(1) This Schedule applies if a person (“the applicant”) mentioned in sub-paragraph (2) notifies the licensing authority that the applicant wishes the licensing authority to submit the proposal or as the case may be the decision to review upon oral representations under—U.K.

(a)regulation 27(3)(b);

(b)regulation 45H(3)(b);

(c)regulation 45R(3)(b);

(d)regulation 256J(4)(b); or

(e)Part 1, 2 or 3 of Schedule 11.

(2) Those persons are—

(a)in respect of notification under regulation 27(3)(b) the licence holder;

(b)in respect of a notification under regulation 45H(3)(b) the person registered as a broker;

(c)in respect of a notification under regulation 45R(3)(b) the person with an active substance registration;

(d)in respect of a notification under regulation 256J(4)(b) the person on the list in accordance with Part 12A; and

(e)in respect of a notification under Part 1, 2 or 3 of Schedule 11—

(i)an applicant for a UK marketing authorisation, [F1370parallel import licence,] certificate of registration or traditional herbal registration,

(ii)an applicant for the renewal of an authorisation, [F1371licence,] certificate or registration, and

(iii)the holder of an authorisation, [F1371licence,] certificate or registration.]

Textual Amendments

Appointment of reviewersU.K.

2.—(1) The licensing authority must—U.K.

(a)appoint a panel of at least two persons (“the reviewers”) to conduct the review; and

(b)provide facilities for the applicant to have the opportunity to appear before the reviewers.

(2) A person must not be appointed under sub-paragraph (1) if within the period of one year immediately preceding that time the person has been a member of—

(a)the Commission;

(b)an expert committee appointed by the licensing authority;

(c)an expert advisory group;

(d)the British Pharmacopoeia Commission or any of its sub-committees;

(e)the Advisory Board on the Registration of Homoeopathic Products formerly established under section 4 of the Medicines Act 1968; or

(f)the Herbal Medicines Advisory Committee formerly established under section 4 of the Medicines Act 1968.

(3) A person appointed under sub-paragraph (1) must not be an officer or servant of a Minister of the Crown, the Scottish Ministers, the Welsh Ministers or a Northern Ireland Minister.

Procedure before hearingU.K.

3.—(1) The applicant must supply the reviewers with a written summary of the oral representations that the applicant wishes to make and any documents on which the applicant wishes to rely in support of them before the end of the period of three months beginning with the date of the notification mentioned in paragraph 1.U.K.

(2) The reviewers may, at the request of the applicant and after consulting the licensing authority, extend the period mentioned in sub-paragraph (1) up to a maximum of six months beginning with the date of that notification.

(3) The applicant may submit additional written representations or documents after the end of the periods for doing so only with the permission of the reviewers.

(4) In the case of a decision or a proposal by the licensing authority under Part 1, 2 or 3 of Schedule 11, the representations and documents referred to in paragraphs (1) and (3)—

(a)must not be based on any evidence or data that was not available to the licensing authority at the time that the decision or, as the case may be, the proposal that is the subject of the review was notified to the applicant by the licensing authority; unless

(b)the evidence or data is unfavourable in respect of the safety, quality or efficacy of the product concerned.

(5) The reviewers must notify the applicant and the licensing authority of the date of the hearing at least 28 days before that date, unless the applicant and the licensing authority agree to a shorter period of notice.

(6) The reviewers may establish at any stage of the procedures described in this Schedule a date by which all of those procedures, except for the hearing, must be completed, and notify this date to the applicant and to the licensing authority.

(7) The date established under sub-paragraph (6) must not be earlier than whichever is the earlier of—

(a)the first day after the end of the period of three months beginning with the date of the notification mentioned in paragraph 1; or

(b)the first day after the end of the period of 28 days beginning with the date on which the reviewers receive the written summary of the oral representations and supporting documents submitted in accordance with sub-paragraphs (1) and (3) of this paragraph,

and in any case not earlier than the first day after the period of seven days beginning on the day after the notification under sub-paragraph (6).

(8) A date established under sub-paragraph (6) may be varied or withdrawn on the application of the applicant or of the licensing authority.

(9) In the case of a decision or a proposal by the licensing authority under Part 1, 2 or 3 of Schedule 11, the reviewers must not take into account any documents or other evidence, or any representations based on such documents or evidence, in the conduct of the hearing if it thinks that the data or evidence on which the documents or representations are based, or the evidence that is presented, were not available to the licensing authority at the time when the decision or, as the case may be, the proposal that is the subject of the review was notified to the applicant by the licensing authority, unless the evidence or data is unfavourable in respect of the safety, quality or efficacy of the product concerned.

(10) The reviewers may give such other directions as they think fit for the conduct of the hearing, including—

(a)the postponing or adjournment of the hearing for such period as it may decide; and

(b)establishing a list of documents that will be taken into account in the conduct of the hearing.

(11) If the applicant fails to comply with a time limit under sub-paragraph (1), (2) or (6)—

(a)the applicant may not appear before the reviewers; and

(b)the licensing authority must decide whether—

(i)to proceed with its proposal to revoke, vary or suspend the licence,

(ii)to confirm or alter its decision,

F1372(iii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iv)to grant or renew the UK marketing authorisation, [F1373parallel import licence,] certificate of registration or traditional herbal registration or to do so otherwise than in accordance with the application, F1374...

(v)to revoke, vary or suspend the authorisation, [F1375licence,] certificate or registration,

[F1376(vi)to proceed to suspend, vary or remove the person’s broker registration,

(vii)ro proceed to suspend, vary or remove the person’s active substance registration, or

(viii)to proceed to suspend, vary or remove the person’s entry on the list,]

as the case may be.

(12) The licensing authority must notify the applicant of its decision.

Textual Amendments

F1374Word in Sch. 5 para. 3(11)(b)(iv) omitted (20.8.2013) by virtue of The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 32(b)(i)

F1376Sch. 5 para. 3(11)(b)(vi)-(viii) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 32(b)(ii)

Procedure at hearingU.K.

4.—(1) Both the applicant and the licensing authority may make representations at the hearing.U.K.

(2) The hearing must be in public if the applicant so requests.

(3) If the applicant fails to appear at the hearing, the reviewers may conduct the review on the basis of the applicant's written summary of the oral representations and supporting documents submitted in accordance with sub-paragraphs (1), (2) and (3) of paragraph 3.

Procedure following hearingU.K.

5.—(1) After the hearing the reviewers must provide a report to the licensing authority and to the applicant either—U.K.

(a)by the end of the period of 60 days beginning with the day after the conclusion of the hearing; or

(b)within such further period as the reviewers may notify to the licensing authority and to the applicant within that 60 day period.

(2) The licensing authority must take the report into account and decide whether—

(a)to proceed with its proposal to revoke, vary or suspend the licence;

(b)to confirm or alter its decision;

F1377(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)to grant or renew the UK marketing authorisation, [F1378parallel import licence,] certificate of registration or traditional herbal registration or to do so otherwise than in accordance with the application; F1379...

[F1380(e)to revoke, vary or suspend the authorisation, certificate or registration;

(f)to proceed to suspend, vary or remove a person’s broker registration;

(g)to proceed to suspend, vary or remove a person’s active substance registration; or

(h)to proceed to suspend, vary or remove a person’s entry on the list,]

as the case may be.

(3) The licensing authority must notify the applicant of its decision.

Textual Amendments

F1379Word in Sch. 5 para. 5(2)(d) omitted (20.8.2013) by virtue of The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 32(c)(i)

F1380Sch. 5 para. 5(2)(e)-(h) substituted for Sch. 5 para. 5(2)(e) (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 32(c)(ii)

Regulations 36(3) and 42(3)

SCHEDULE 6U.K.Manufacturer's and wholesale dealer's licences for exempt advanced therapy medicinal products

PART 1U.K.Manufacturer's licences

1.  The requirements in paragraphs 2 to 12 apply to a manufacturer's licence insofar as it relates to the manufacture and assembly of exempt advanced therapy medicinal products.U.K.

2.  The licence holder must inform the licensing authority of any adverse reaction or suspected adverse reaction of which the holder is aware within the period of 15 days beginning on the day following the first day on which the holder knew about the reaction.U.K.

3.  The licence holder must ensure, if using human cells or tissues in an exempt advanced therapy medicinal product, that the donation, procurement and testing of those cells or tissues is in accordance with [F1381requirements imposed pursuant to—U.K.

(a)paragraphs 6 to 9 of Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards gametes and embryos; and

(b)paragraphs 9 to 12 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other tissues and cells.]

Textual Amendments

4.  The licence holder must ensure that any human tissue or cell component imported into the United Kingdom and used by the holder as a starting material or raw material in the manufacture of an exempt advanced therapy medicinal product shall meet equivalent standards of quality and safety to those [F1382imposed pursuant to—U.K.

(a)Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards gametes and embryos; and

(b)Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other tissues and cells.]

Textual Amendments

5.  The licence holder must ensure that any blood or blood component imported into the United Kingdom and used by the manufacturer's licence holder as a starting material or raw material in the manufacture of an exempt advanced therapy medicinal product meets equivalent standards of quality and safety to those laid down in [F1383the Blood Quality and Safety Regulations 2005].U.K.

Textual Amendments

6.  Where the holder of a manufacturer's licence distributes by way of wholesale dealing any exempt advanced therapy medicinal product manufactured or assembled pursuant to the licence that person must comply with—U.K.

(a)the requirements of paragraphs 15, 16, 18 and 19; and

(b)the guidelines on good distribution practice published by the European Commission in accordance with Article 84 of the 2001 Directive;

as if that person were the holder of a wholesale dealer's licence.

7.  The licence holder must, at the written request of the licensing authority, set up a risk management system designed to identify, characterise, prevent or minimise risks related to the exempt advanced therapy medicinal product.U.K.

8.  The licence holder must establish and maintain a system ensuring that the exempt advanced therapy medicinal product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the establishment where the product is used.U.K.

9.  The licence holder must, subject to paragraph 27 of Schedule 4, keep the data referred to in paragraph 8 for a minimum of 30 years after the expiry date of the exempt advanced therapy medicinal product.U.K.

10.  The licence holder must secure that the data referred to in paragraph 8 will, in the event that—U.K.

(a)the licence is suspended, revoked or withdrawn; or

(b)the licence holder becomes bankrupt or insolvent,

be held available to the licensing authority by the holder of a manufacturer's licence for the period described in paragraph 9 or such longer period as may be required pursuant to paragraph 27 of Schedule 4.

11.  The licence holder must, where an exempt advanced therapy medicinal product contains human cells or tissues, ensure that the traceability system established in accordance with paragraph 8 is complementary to and compatible with the requirements [F1384imposed pursuant to—U.K.

(a)as regards gametes and embryos, sections 12(3), and 33A to 33D of, and paragraph 1 of Schedule 3A to, the Human Fertilisation and Embryology Act 1990;

(b)as regards blood cells, regulations 8, 9(e) and 14 of the Blood Safety and Quality Regulations 2005; and

(c)as regards other cells and tissues, regulations 13 and 16 of, and paragraph 1 of Schedule 2 to, the Human Tissue (Quality and Safety for Human Application) Regulations 2007].

Textual Amendments

12.  The licence holder must not import or export any exempt advanced therapy medicinal product.U.K.

PART 2U.K.Wholesale dealer's licences

13.  The requirements in paragraphs 14 to 20 apply to a wholesale dealer's licence insofar as it relates to exempt advanced therapy medicinal products.U.K.

14.  The licence holder must obtain supplies of exempt advanced therapy medicinal products only from—U.K.

(a)the holder of a manufacturer's licence in respect of those products; or

(b)the holder of a wholesale dealer's licence in respect of those products.

15.  The licence holder must distribute an exempt advanced therapy medicinal product by way of wholesale dealing only to—U.K.

(a)the holder of a wholesale dealer's licence in respect of those products; or

(b)a person who—

(i)may lawfully administer those products, and

(ii)solicited the product for an individual patient.

16.  The licence holder must establish and maintain a system ensuring that the exempt advanced therapy medicinal product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the establishment where the product is used.U.K.

17.  The licence holder must inform the licensing authority of any adverse reaction to any exempt advanced therapy medicinal product supplied by the holder of the wholesale dealer's licence of which the holder is aware.U.K.

18.  The licence holder must, subject to paragraph 44 of Schedule 4, keep the data referred to in paragraph 16 for a minimum of 30 years after the expiry date of the exempt advanced therapy medicinal product.U.K.

19.  The licence holder must secure that the data referred to in paragraph 16 will, in the event that—U.K.

(a)the licence is suspended, revoked or withdrawn; or

(b)the licence holder becomes bankrupt or insolvent,

be held available to the licensing authority by the holder of a wholesale dealer's licence for the period described in paragraph 18 or such longer period as may be required pursuant to paragraph 44 of Schedule 4.

20.  The licence holder must not import or export any exempt advanced therapy medicinal product.U.K.

Regulation 41

SCHEDULE 7U.K.Qualified persons

PART 1U.K.Qualification requirements for qualified person

1.  A person must satisfy the requirements in paragraphs 2 and 8 or, alternatively, the requirements in paragraphs 7 and 8, of this Schedule before acting as a qualified person (but this is subject to Part 2).U.K.

2.  The person must have a degree, diploma or other formal qualification which satisfies the requirements of this Part, in one of the following subjects—U.K.

(a)pharmacy;

(b)medicine;

(c)veterinary medicine;

(d)chemistry;

(e)pharmaceutical chemistry and technology; or

(f)biology,

but this paragraph is subject to paragraph 7.

3.  A qualification satisfies the requirements of this Part if it is awarded on completion of a university course of study, or a course recognised as equivalent by [F1385the licensing authority], which—U.K.

(a)satisfies the minimum requirements specified in paragraph 4; and

(b)extends over a period of at least four years of theoretical and practical study of a subject specified in paragraph 2 (but this is subject to paragraphs 5 and 6).

Textual Amendments

4.—(1) A course should include at least the following core subjects—U.K.

(a)experimental physics;

(b)general and inorganic chemistry;

(c)organic chemistry;

(d)analytical chemistry;

(e)pharmaceutical chemistry, including analysis of medicinal products;

(f)general and applied medical biochemistry;

(g)physiology;

(h)microbiology;

(i)pharmacology;

(j)pharmaceutical technology;

(k)toxicology; and

(l)pharmacognosy.

(2) The subjects mentioned in sub-paragraph (1) should be balanced in such a way as to enable the person to fulfil the obligations specified in Part 3 of this Schedule.

5.  If the course referred to in paragraph 3 is followed by a period of theoretical and practical training of at least one year, including a training period of at least six months in a pharmacy open to the public and a final examination at university level, the minimum duration of the course is three and a half years.U.K.

6.  If two university courses, or courses recognised as of university equivalent standard, co-exist, one of which extends over four years and the other over three years, the three-year course is to be treated as fulfilling the condition as to the duration of the course in paragraph 3, provided that [F1386the licensing authority] recognises the formal qualifications gained from each course as being equivalent.U.K.

Textual Amendments

7.  If the person's formal qualifications do not satisfy the requirements of this Part, the person may act as a qualified person if the licensing authority is satisfied, on the production of evidence, that the person has adequate knowledge of the subjects specified in paragraph 4(1).U.K.

8.—(1) The person must (subject to sub-paragraph (2)) have at least two years' practical experience in an undertaking authorised to manufacture medicinal products of—U.K.

(a)qualitative analysis of medicinal products;

(b)quantitative analysis of active substances; and

(c)the testing and checking necessary to ensure the quality of medicinal products.

(2) But—

(a)if the person has completed a university course lasting at least five years, the minimum period of practical experience under this paragraph is one year; and

(b)if the person has completed a university course lasting at least six years, the minimum period of practical experience under this paragraph is six months.

PART 2U.K.Qualified persons with long experience

9.—(1) This paragraph applies to a person who has acted as a qualified person since the coming into force of Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products M78.U.K.

(2) A person to whom this paragraph applies may continue to act as a qualified person.

Marginal Citations

M78OJ No L 147, 9.6.1975, p.13, no longer in force.

10.—(1) This paragraph applies to a person who—U.K.

(a)holds a degree, diploma or other formal qualification in a scientific discipline awarded on completion of a university course or course recognised as equivalent; and

(b)began the course before 21 May 1975.

(2) A person to whom this paragraph applies may act as a qualified person provided that sub-paragraph (3) (and, where applicable, paragraph 11) is satisfied.

(3) This sub-paragraph is satisfied if, for at least two years before 21 May 1985, the person has carried out one of the following activities in an undertaking authorised to manufacture medicinal products—

(a)production supervision;

(b)qualitative and quantitative analysis of active substances; or

(c)testing and checking, under the direct supervision of the qualified person in respect of the undertaking, to ensure the quality of the medicinal products.

11.  If a person to whom paragraph 10 applies acquired the practical experience mentioned in paragraph 10(3) before 21 May 1965, the person must complete a further one year's practical experience of the kind specified in that paragraph immediately before the person may act as a qualified person.U.K.

PART 3U.K.Obligations of qualified person

12.—[F1387(1)] [F1388In Great Britain, the qualified person] is responsible for securing—

(a)that each batch of medicinal products manufactured in [F1389Great Britain] has been manufactured and checked in accordance with these Regulations and the requirements of the [F1390UK marketing authorisation], certificate of registration or traditional herbal registration [F1391, or an equivalent authorisation,] relating to those products; F1392... [F1393and]

(b)in the case of [F1394medicinal products imported from a country other than approved country for import, irrespective of whether the products have been manufactured in the United Kingdom or an approved country for import], that each batch has undergone—

(i)a full qualitative analysis,

(ii)a quantitative analysis of all the active substances, and

(iii)all other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the [F1395UK marketing authorisation], certificate of registration or traditional herbal registration [F1396, or an equivalent authorisation,] relating to those products; [F1397and]

F1398(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F1399(2) In this paragraph “equivalent authorisation” means, in respect of a medicinal product that does not have a UK marketing authorisation, certificate of registration or traditional herbal registration, such equivalent authorisation or registration granted by an appropriate authority for the licensing of medicinal products in an approved country for import.]

Textual Amendments

F1392Word in Sch. 7 para. 12(a) omitted (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 17(a) and word in Sch. 7 para. 12(a) omitted (N.I.) (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 17(a)

F1397Sch. 7 para. 12(c) and preceding word inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 17(b) and Sch. 7 para. 12(c) and preceding word inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 17(b)

[F140012A.—(1) In Northern Ireland, the qualified person is responsible for securing—U.K.

(a)that each batch of medicinal products manufactured in Northern Ireland has been manufactured and checked in accordance with these Regulations and the requirements of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to those products; and

(b)in the case of medicinal products imported from a country other than an EEA State, irrespective of whether the products have been manufactured in Northern Ireland or an EEA State, that each batch has undergone—

(i)a full qualitative analysis,

(ii)a quantitative analysis of all the active substances, and

(iii)all other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to those products[F1401.]

F1402(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F1403(2) This paragraph does not apply in relation to listed NIMAR products in Northern Ireland.]]

Textual Amendments

[F140412B.  In the case of an MM medicinal product or a POC medicinal product, the obligations in paragraphs 12(1)(a) and 12A(1)(a) may be satisfied by securing that each product has been manufactured and checked in accordance with these Regulations and the requirements of the marketing authorisation relating to the product.]U.K.

Textual Amendments

13.—(1) This paragraph applies [F1405in Northern Ireland] where—U.K.

(a)a medicinal product which has undergone the controls referred to in [F1406paragraph 12A in a member State is imported to Northern Ireland]; and

(b)each batch of the product is accompanied by control reports signed by another qualified person in respect of the medicinal product.

(2) Where this paragraph applies, the qualified person is not responsible for carrying out the controls referred to in paragraph [F140712A].

Textual Amendments

14.—(1) This paragraph applies where—U.K.

(a)medicinal products are imported [F1408into Great Britain from a country other than an approved country for import or into Northern Ireland] from a country other than an EEA State; and

[F1409(b)appropriate arrangements have been made, in the case of import into Great Britain by the licensing authority with the country from which those products are imported and, in the case of a product for import into Northern Ireland by the European Union with that country, to ensure that—

(i)the manufacturer of the medicinal products applies standards of good manufacturing practice at least equivalent to those laid down—

(aa)in the case of a product for sale or supply in Great Britain, in the Good Manufacturing Practice Directive, as supplemented by the guidelines and principles which apply under, or by virtue of, regulation C17, and

(bb)in the case of a product for sale or supply in Northern Ireland, by the European Union;

(ii)the controls referred to in paragraph 12(b) or 12A(b) (as appropriate) have been carried out in that country.]

(2) Where this paragraph applies, the qualified person is not responsible for carrying out the controls referred to in paragraph 12 [F1410or 12A].

[F1411(3) The licensing authority must publish a list of the countries with whom it has made appropriate arrangements under sub-paragraph (1)(b) (“approved country for batch testing list”).

(4) A country may be included in the approved country for batch testing list subject to any condition or restriction that the licensing authority considers appropriate, including as to categories of medicinal product, and any such condition or restriction must be included in the list.

(5) In order to satisfy itself of the matters specified in sub-paragraph (1)(b)(i) and (ii), the licensing authority may, in particular, take into account—

(a)the country's rules for good manufacturing practice;

(b)the regularity of inspections to verify compliance with good manufacturing practice;

(c)the effectiveness of enforcement of good manufacturing practice;

(d)the regularity and rapidity of information provided by that country relating to non-compliant manufacturers;

(e)any on-site review of that country's regulatory system undertaken by the licensing authority;

(f)any on-site inspection of a manufacturing site in that country observed by the licensing authority;

(g)any other relevant documentation available to the licensing authority.

(6) The licensing authority must—

(a)review any appropriate arrangements it has made under sub-paragraph (1)(b) to determine if that country still satisfies the requirements of sub-paragraph (1)(b)(i) and (ii), and whether any condition or restriction in those arrangements remains appropriate;

(b)if it is not so satisfied, remove that country from the approved country for batch testing list or, as the case may be, amend or remove that condition or restriction; and

(c)undertake such a review at least every three years beginning with the date on which the country is included in that list.]

Textual Amendments

15.—(1) The qualified person is responsible for ensuring, in relation to a medicinal product, that documentary evidence is produced that each batch of the product satisfies the requirements of paragraph 12.U.K.

(2) The documentary evidence referred to in sub-paragraph (1) must be kept up to date and must be available for inspection by the licensing authority for a period of at least five years.

Regulation 45N(5)(b)

[F1412SCHEDULE 7AU.K.Information to be provided for registration as an importer, manufacturer or distributor of active substances

Textual Amendments

1.  The name and address of the applicant.U.K.

2.  The name and address of the person (if any) making the application on the applicant’s behalf.U.K.

3.  The address of each of the premises where any operations to which the registration relates are to be carried out.U.K.

4.  The address of any premises not mentioned by virtue of the above requirement, where—U.K.

(a)the applicant proposes to keep any living animals, from which substance(s) used in the production of the active substance(s) to which the application relates are to be derived;

(b)materials of animal origin from which an active substance is to be derived, as mentioned in the above sub-paragraph, are to be kept.

5.  The address of each of the premises where active substances are to be stored, or from which active substances are to be distributed.U.K.

6.  The address of each of the premises where any testing associated with the manufacture or assembly of active substances to which the registration relates.U.K.

7.  The name, address, qualifications and experience of the person whose duty it will be to supervise any manufacturing operations, and the name and job title of the person to whom they report.U.K.

8.  The name, address, qualifications and experience of the person who will have responsibility for the quality control of active substances, and the name and job title of the person to whom they report.U.K.

9.  The name, address, qualifications and experience of the person whose duty it will be to supervise any importation, storage or distribution operations, and the name and job title of the person to whom they report.U.K.

10.  The name, address and qualifications of the person to be responsible for any animals kept as mentioned in paragraph 4(a).U.K.

11.  The name, address and qualifications of the person to be responsible for the culture of any living tissue for use in the manufacture of an active substance.U.K.

12.  For each active substance to be manufactured, imported, or distributed—U.K.

(a)the CAS registration number assigned to that active substance by the Chemical Abstracts Service, a division of the American Chemical Society;

(b)where applicable, the Anatomical Therapeutic Category code assigned to that active substance under the Anatomical Therapeutic Chemical Classification System used for the classification of drugs by the World Health Organisation’s Collaborating Centre for Drug Statistics Methodology;

(c)either—

(i)the International Union of Pure and Applied Chemistry nomenclature, or

(ii)the common name; and

(d)the intended quantities of each active substance to be manufactured, imported or distributed.

13.  Details of the operations to which the registration relates, including a statement of whether they include—U.K.

(a)the manufacture of active substances;

(b)the importation of active substances F1413...;

(c)the storage of active substances; or

(d)the distribution of active substances.

Textual Amendments

14.  A statement of the facilities and equipment available at each of the premises where active substances are to be manufactured, stored or distributed.U.K.

15.  A statement as to whether the particular active substances are intended for—U.K.

F1414(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)use in a special medicinal product; or

(c)export F1415....

Textual Amendments

16.  A separate statement in respect of each of the premises mentioned in the application of—U.K.

(a)the manufacturing, storage or distribution operations carried out at those sites, and the specific active substances to which those activities relate; and

(b)the equipment available at those premises for carrying out those activities.

17.  A statement of the authority conferred on the person responsible for quality control to reject unsatisfactory active substances.U.K.

18.  A description of the arrangements for the identification and storage of materials before and during the manufacture of active substances.U.K.

19.  A description of the arrangements for the identification and storage of active substances.U.K.

20.  A description of the arrangements at each of the premises where the applicant proposes to store active substances for ensuring, as far as practicable, the turn-over of stocks of active substances.U.K.

21.  A description of the arrangements for maintaining—U.K.

(a)production records, including records of manufacture and assembly;

(b)records of analytical and other tests used in the course of manufacture or assembly for ensuring compliance of materials use in manufacture, or of active substances, with the specification for such materials or active substances;

(c)records of importation;

(d)records of storage and distribution.

22.  A description of the arrangements for keeping reference samples of—U.K.

(a)materials used in the manufacture of active substances; and

(b)active substances.

23.  Where the application relates to active substances intended for use in an advanced therapy medicinal product, an outline of the arrangements for maintaining records to allow traceability containing sufficient detail to enable the linking of an active substance to the advanced therapy medicinal product it was used in the manufacture of and vice versa.U.K.

24.  Details of—U.K.

(a)any manufacturing, importation, storage or distribution operations, other than those to which the application for registration relates, carried on by the applicant on or near each of the premises, and

(b)the substances or articles to which those operations relate.]

Regulation 50(1)

SCHEDULE 8U.K.Material to accompany an application for a UK marketing authorisation

PART 1U.K.General requirements

1.  The name or corporate name and permanent address of the applicant and (where applicable) of the manufacturer of the medicinal product.U.K.

2.  The name of the medicinal product. This may be—U.K.

(a)an invented name that is not liable to confusion with the product's common name; or

(b)a common or scientific name accompanied by a trademark or by the name of the person who is to be the marketing authorisation holder.

3.  Qualitative and quantitative particulars of the constituents of the medicinal product, including—U.K.

(a)where there is an international non-proprietary name recommended by the World Health Organisation for a constituent, a reference to that name; or

(b)otherwise, a reference to the relevant chemical name.

4.  An evaluation of the potential environmental risks posed by the medicinal product, including an assessment of its environmental impact and a description of the proposed arrangements for limiting that impact on a case by case basis.U.K.

5.  A description of the methods of manufacturing the medicinal product.U.K.

6.  The therapeutic indications and contra-indications for the medicinal product and the adverse reactions associated with it.U.K.

7.  The posology and pharmaceutical form of the medicinal product, its method and route of administration and its expected shelf life.U.K.

8.  The reasons for any precautionary and safety measures to be taken for—U.K.

(a)the storage of the medicinal product;

(b)the administration of the medicinal product to patients; and

(c)the disposal of the medicinal product and any waste products,

with an indication of the potential risks presented by the medicinal product for the environment.

9.  A description of the control methods employed by the manufacturer.U.K.

[F14169A.  [F1417Except in the case of an active substance that contains human cells or tissues, or that is part of a medicinal product which is (or is in a form which means a dose or part of it is) to be administered immediately after manufacture,] a written confirmation that the manufacturer of the medicinal product has verified compliance of the manufacturer of the active substance with the principles and guidelines of good manufacturing practice by conducting audits, in accordance with regulation 37(5)(a) and containing—U.K.

(a)information about the date of the audit; and

(b)a declaration that the outcome of the audit confirms that the manufacturing complies with the principles and guidelines of good manufacturing practice.]

Textual Amendments

10.  The results of the following in relation to the medicinal product and its constituent active substances—U.K.

(a)pharmaceutical (physico-chemical, biological or microbiological) tests;

(b)pre-clinical (toxicological and pharmacological) tests; and

(c)clinical trials.

11.  A detailed summary of those results prepared and signed by an expert with appropriate technical or professional qualifications, which must be set out in a brief curriculum vitae.U.K.

12.  A summary of the applicant's pharmacovigilance system which shall include the following elements—U.K.

(a)proof that the applicant has at the applicant's disposal an appropriately qualified person responsible for pharmacovigilance [F1418who is ordinarily resident, and operates, in the United Kingdom or a member State];

[F1419(b)the country (which must be either the United Kingdom or a member State) in which the appropriately qualified person resides and carries out his or her tasks;]

(c)the contact details of the appropriately qualified person;

(d)a statement signed by the applicant to the effect that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Part 11; and

[F1420(e)a reference to the physical location where the pharmacovigilance system master file for the medicinal product can be accessed electronically, which must be in the United Kingdom.]

Textual Amendments

13.  The risk management plan, together with a summary, that—U.K.

(a)describes the risk management system which the applicant will introduce for the medicinal product concerned; and

(b)shall be proportionate to the identified risks and the potential risks of the medicinal product, and the need for post-authorisation safety data.

14.  Where any clinical trials have been carried out outside the European Union, a statement to the effect that the trials met the ethical requirements of the Clinical Trials Directive.U.K.

15.  A summary of the product characteristics for the medicinal product in accordance with Part 2 of this Schedule.U.K.

[F142116.—(1) Subject to sub-paragraph (2), a mock-up, in accordance with Part 13 (packaging and leaflets) of—U.K.

(a)the outer packaging of the medicinal product;

(b)the immediate packaging of the medicinal product; and

(c)the package leaflet for the medicinal product.

(2) Sub-paragraph (1)(a) and (b) does not apply to an application for a marketing authorisation for a POC medicinal product which is (or is in a form which means a dose or part of it is) to be administered immediately after manufacture.]

Textual Amendments

17.  A document showing that the manufacturer of the medicinal product is authorised to produce medicinal products in the manufacturer's own country.U.K.

[F142218.   Where—U.K.

F1423(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)F1424... an application for authorisation for the medicinal product to be placed on the market is under consideration in a country other than the United Kingdom, or by the EMA, notification of that fact.]

Textual Amendments

19.  Where an authorisation for the medicinal product to be placed on the market has been granted by [F1425, in the case of a medicinal product for sale or supply in Northern Ireland, a member State or by a country other than an EEA State, or in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom or by the European Commission]—U.K.

(a)a copy of that authorisation;

(b)a summary of the safety data, including the data contained in the periodic safety update reports, where available; and

(c)any suspected adverse reaction reports.

Textual Amendments

20.  Where [F1426, in the case of a medicinal product for sale or supply in Northern Ireland,] an authorisation for the medicinal product to be placed on the market has been granted by a member State in accordance with the 2001 Directive, a copy of—U.K.

(a)the summary of the product characteristics approved by the competent authority of the member State; and

(b)the package leaflet approved by that competent authority.

Textual Amendments

[F142721.  Where an authorisation for the medicinal product to be placed on the market has been refused—U.K.

(a)in the case of a medicinal product for sale or supply in Northern Ireland, by a member State or by a country other than an EEA State, or

(b)in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom,

details of that decision and of the reasons for it.]

Textual Amendments

22.  [F1428 In the case of a medicinal product for sale or supply in Northern Ireland, a copy of any] designation of the medicinal product as an orphan medicinal product under Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products M79 together with a copy of the relevant Agency opinion.

Textual Amendments

Marginal Citations

M79OJ No L 18, 22.1.2000, p.1, as amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p.14.

PART 2U.K.Summary of the product characteristics

The summary of the product characteristics must contain the following information in the following order—

[F142923.  For medicinal products included on the list referred to—U.K.

(a)in the case of a [F1430UKMA(NI) or a UKMA(UK)(Category 2)], in Article 23 of Regulation (EC) No 726/2004, the symbol and statement “▼ This medicinal product is subject to additional monitoring”, or

(b)in the case of a [F1431UKMA(GB) or a UKMA(UK)(Category 1)], in regulation 202A, the symbol and statement “▼ This medicinal product is subject to additional monitoring”.]

Textual Amendments

24.  The name of the medicinal product followed by its strength and pharmaceutical form.U.K.

25.  The qualitative and quantitative composition, using the usual common name or chemical description, of the medicinal product in terms of—U.K.

(a)the active substances; and

(b)those excipients of which knowledge is essential for proper administration of the medicinal product.

[F143225A.  In the case of an advanced therapy medicinal product F1433... which contains cells or tissues, a detailed description of those cells or tissues and of their specific origin, including the species of animal in cases of non-human origin.]U.K.

Textual Amendments

26.  The pharmaceutical form of the medicinal product.U.K.

27.  Clinical particulars in relation to the medicinal product, covering—U.K.

(a)therapeutic indications;

(b)posology and method of administration for adults and, where necessary, for children;

therapeutic indications;

(c)contra-indications;

(d)special warnings and precautions for use and, in the case of immunological medicinal products any special precautions to be taken by persons handling such products and administering them to patients, together with any precautions to be taken by the patient;

(e)interaction with other medicinal products and other forms of interactions;

(f)use during pregnancy and lactation;

(g)effects on ability to drive and to use machines;

(h)other undesirable effects; and

(i)information on overdose (including symptoms, emergency procedures and antidotes).

28.  The pharmacological properties of the medicinal product, covering—U.K.

(a)pharmacodynamic properties;

(b)pharmacokinetic properties; and

(c)pre-clinical safety data.

29.  Pharmaceutical particulars in relation to the medicinal product, covering—U.K.

(a)a list of excipients;

(b)major incompatibilities;

(c)shelf life after reconstitution of the medicinal product or when the immediate packaging is opened for the first time (as appropriate);

(d)special precautions for storage;

(e)nature and contents of container; and

(f)special precautions for disposal of the used medicinal product or waste materials derived from the medicinal product (as appropriate).

30.  The holder of the UK marketing authorisation.U.K.

31.  The number of the UK marketing authorisation.U.K.

32.  The date of the first UK marketing authorisation or, where the UK marketing authorisation has been renewed, the date of the last renewal.U.K.

33.  The date of any revisions of the text of the summary of the product characteristics.U.K.

34.  For radiopharmaceuticals, full details of internal radiation dosimetry.U.K.

35.  For radiopharmaceuticals, additional detailed instructions for extemporaneous preparation and quality control of such preparation and, where appropriate, maximum storage time during which any intermediate preparation such as an eluate or the ready-to-use pharmaceutical will conform with its specifications.U.K.

[F143436.  In the case of an advanced therapy medicinal product for sale or supply in Great Britain—U.K.

(a)references in this Part of this Schedule to administration of a product include references to the advanced therapy medicinal product's use, application or implantation; and

(b)descriptions, instructions and warnings must include explanatory drawings and pictures where necessary.]

Textual Amendments

Regulation 50(1A)

[F1435SCHEDULE 8AU.K.Material to accompany an application for a parallel import licence

Textual Amendments

1.  The name or corporate name and permanent address of the applicant.U.K.

2.  The name of the medicinal product. This may be—U.K.

(a)an invented name that is not liable to confusion with the product’s common name; or

(b)a common or scientific name accompanied by a trademark or by the name of the person who is to be the parallel import licence holder.

3.  Details of the product to be imported if requested by the licensing authority.U.K.

4.  Details of the UK reference product.U.K.

5.  If requested by the licensing authority, an evaluation of the potential environmental risks posed by the medicinal product, including an assessment of its environmental impact and a description of the proposed arrangements for limiting that impact on a case by case basis.U.K.

6.  If requested by the licensing authority, a summary of the applicant’s pharmacovigilance system which shall include the following elements—U.K.

(a)proof that the applicant has at the applicant’s disposal an appropriately qualified person responsible for pharmacovigilance [F1436who resides and operates in the United Kingdom];

F1437(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)the contact details of the appropriately qualified person;

(d)a statement signed by the applicant to the effect that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Part 11; and

(e)a reference to the location where the pharmacovigilance system master file for the medicinal product is kept [F1438or, if kept in electronic form, from which it can be accessed, which in either case, must be in the United Kingdom].

Textual Amendments

7.  If requested by the licensing authority, the risk management plan, together with a summary, that—U.K.

(a)describes the risk management system which the applicant will introduce for the medicinal product concerned; and

(b)shall be proportionate to the identified risks and the potential risks of the medicinal product, and the need for post-authorisation safety data.

8.  If requested by the licensing authority, a summary of the product characteristics for the medicinal product in accordance with Part 2 of Schedule 8.U.K.

9.  A mock-up, in accordance with Part 13 (packaging and leaflets) of—U.K.

(a)the outer packaging of the medicinal product;

(b)the immediate packaging of the medicinal product; and

(c)the package leaflet for the medicinal product.]

Regulation 8(1)

[F1439SCHEDULE 8BU.K.Modifications of Annex I to the 2001 Directive

Textual Amendments

Provision of Annex IModification subject to which that provision is to be read
Paragraph (1) of the Introduction and general principlesThe reference to “Articles 8 and 10(1)” is to be read as a reference to regulation 50 of the Human Medicines Regulations 2012.
Paragraphs (1) and (2) of the Introduction and general principlesIf the licensing authority has published guidelines under regulation 50(5B)(a) of the Human Medicines Regulations 2012, the reference to “the rules governing medicinal products in the European Community, Volume 2B, Notice to applicants, medicinal products for human use, presentation and content of the dossier, Common Technical Document” is to be read as a reference to that guidance.
Paragraph (4) of the Introduction and general principlesIf the licensing authority has published guidelines under regulation 50(5B)(b) of the Human Medicines Regulations 2012, the reference to “the scientific guidelines relating to the quality, safety and efficacy of medicinal products for human use as adopted by the Committee for Proprietary Medicinal Products (CPMP) and the European Medicines Evaluation Agency (EMEA) and the other pharmaceutical Community guidelines published by the Commission in the different volumes of the rules governing medicinal products in the European Community” is to be read as a reference to those guidelines.
Paragraph (6) of the Introduction and general principlesThe reference to “the requirements of Commission Directive 91/356/EEC laying down the principles of and guidelines of Good Manufacturing Practice for medicinal products for human use” is to be read as a reference to the Good Manufacturing Practice Directive, as defined in regulation 8(1) of the Human Medicines Regulations 2012.
Paragraph (6) of the Introduction and general principlesIf the licensing authority has published principles and guidelines under regulation C17(1) of the Human Medicines Regulations 2012, the reference to “the principles and guidelines on GMP published by the Commission in the rules governing medicinal products in the European Community, Volume 4” is to be read as a reference to those principles and guidelines.
Paragraph (8) of the Introduction and general principlesReferences to “the European Community” are to be read as references to the United Kingdom.
Paragraph (8) of the Introduction and general principlesThe references to “Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use” are to be read as references to the Medicinal Products for Human Use (Clinical Trials) Regulations 2004.
Paragraph (9) of the Introduction and general principlesThe reference to “Council Directives 87/18/EEC on the harmonisation of regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests in chemical substances and 88/320/EEC on the inspection and verification of good laboratory practice” is to be read as a reference to the Good Laboratory Practice Regulations 1999.
Paragraph (10) of the Introduction and general principlesThe reference to “Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulation and administrative provisions of the Member States regarding the protection of animals for experimental and other scientific purposes” is to be read as a reference to the Animals (Scientific Procedures) Act 1986.
Paragraph (11) of the Introduction and general principlesThe paragraph is to be read as follows: “In order to monitor the benefit/risk assessment, any new information not in the original application and all pharmacovigilance information shall be submitted to the licensing authority. After a marketing authorisation has been granted, any change to the data in the dossier shall be submitted to the licensing authority in accordance with the requirements of Schedule 10A to the Human Medicines Regulations 2012, as well as the requirements of Schedule 12A to those Regulations.”
Part I, paragraph 1.2, fourth paragraphThis paragraph is to be read as follows: “Annexed to the administrative data shall be copies of the manufacturing authorisation as defined in regulation 17 of the Human Medicines Regulations 2012.”
Part I, paragraph 1.3.1The reference to “Article 11” is to be read as a reference to Part 2 of Schedule 8 to the Human Medicines Regulations 2012.
Part I, paragraph 1.3.2The reference to “Title V” is to be read as a reference to Part I3 of the Human Medicines Regulations 2012, and the references to Articles 63 and 59 are to be read as references to regulations 260 and 266 of the Human Medicines Regulations 2012.
Part I, paragraph 1.3.4This paragraph is to be read as omitted.
Part I, paragraph 1.4The reference to “Article 12.2” is to be read as a reference to paragraph 11 of Schedule 8 to the Human Medicines Regulations 2012.
Part I, paragraph 2, first paragraphThe reference to “Article 12” is to be read as a reference to paragraph 11 of Schedule 8 to the Human Medicines Regulations 2012.
Part I, paragraph 3.2(5), first paragraphThe reference to a “Member State” is to be read as including the United Kingdom.
Part I, paragraph 3.2(5), second paragraphThe references to “the national pharmacopoeia of a Member State” are to be read as including references to the British Pharmacopoeia.
Part I, paragraph 3.2(6)The reference to “the pharmacopoeia of a Member State” is to be read as including a reference to the British Pharmacopoeia.
Part I, paragraph 3.2(12)The words “which is required by Community legislation” are to be read as omitted.
Part I, paragraph 3.2.1.2If the licensing authority has published guidelines under regulation 50(5B)(c) of the Human Medicines Regulations 2012, the reference to “guidelines published by the Agency” is to be read as a reference to those guidelines.
Part I, paragraph 3.2.2.1, second paragraphThe reference to “Article 8(3)(c)” is to be read as a reference to paragraph 3 of Schedule 8 to the Human Medicines Regulations 2012.
Part I, paragraph 3.2.2.1, second paragraph, first indentThe reference to “the national pharmacopoeia of one of the Member States” is to be read as including the British Pharmacopoeia.
Part I, paragraph 3.2.2.1, fifth paragraphThe reference to “any Member State” is to be read as a reference to the United Kingdom and the reference to “the Member States” is to be read as a reference to the United Kingdom.
Part I, paragraph 3.2.2.3(a)The reference to “Article 8(3)(d)” is to be read as a reference to paragraph 5 of Schedule 8 to the Human Medicines Regulations 2012.
Part I, paragraph 4.2.2, fifth paragraphThe reference to “this Directive” is to be read as a reference to the Human Medicines Regulations 2012.
Part I, paragraph 5.2(a)The reference to “the clinical particulars provided pursuant to Articles 8(3)(i) and 10(1)” is to be read as a reference to those particulars provided pursuant to paragraph 10 of Schedule 8 to, and regulations 51A, 52A, 53A and 54 to 56 of, the Human Medicines Regulations 2012.
Part I, paragraph 5.2(c)The references to “the European Community” are to be read as references to the United Kingdom.
Part I, paragraph 5.2(c), fifth paragraphThe reference to “Directive 2001/20/EC and implementing detail guidelines” is to be read as a reference to the Medicinal Products for Human Use (Clinical Trials) Regulations 2004.
Part I, paragraph 5.2.1, second paragraphThe reference to “Article 10(1)(a)” is to be read as a reference to regulation 51A of the Human Medicines Regulations 2012.
Part II, paragraph 1, first paragraphThe reference to “Article 10(1)(a)(ii)” is to be read as a reference to regulation 54 of the Human Medicines Regulations 2012.
Part II, paragraph 2(a)The reference to “Article 10(1)(a)(i)” is to be read as a reference to regulation 56 of the Human Medicines Regulations 2012.
Part II, paragraph 2(b)The reference to “Article 10(1)(a)(ii)” is to be read as a reference to regulation 51A of the Human Medicines Regulations 2012.
Part II, paragraph 4, first paragraphThe first sentence is to be read as omitted and the words “in accordance with regulation 53A of the Human Medicines Regulations 2012” are to be read as added at the end of the second sentence.
Part II, paragraph 5, first paragraphThe reference to “Article 10(1)(b)” is to be read as a reference to regulation 55 of the Human Medicines Regulations 2012.
Part II, paragraph 6, first paragraphThe reference to “Article 22” is to be read as a reference to regulation 60 of the Human Medicines Regulations 2012.
Part III, paragraph 1.1(a), first indentThe reference to “Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EC as regards medical devices incorporating stable derivatives of human blood or blood plasma” is to be read as a reference to the Medical Devices Regulations 2002.
Part III, paragraph 1.1(a), third indentThe reference to “the Agency or the competent authority” is to be read as a reference to the licensing authority.
Part III, paragraph 1.1(a), fourth indentThis indent is to be read as omitted.
Part III, paragraph 1.1(b)The reference to “Article 109, as amended by Directive 2002/98/EC” is to be read as a reference to the Blood Safety and Quality Regulations 2005.
Part III, paragraph 1.1(b)(3), second paragraphThe reference to “medicinal products referred to in Article 2 of Directive 2001/20/EC of the European Parliament and of the Council relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use” is to be read as a reference to investigational medicinal products.
Part III, paragraph 1.1.(c), second indentThis indent is to be read as follows: “The Plasma Master File is subject to a scientific and technical evaluation by the licensing authority.”
Part III, paragraph 1.1(c), fourth indentThis indent is to be read as follows: “Changes subsequently introduced to the terms of a Plasma Master File must follow the variation procedure in Schedule 10A to the Human Medicines Regulations 2012.”
Part III, paragraph 1.1(c), final indentThis indent is to be read as omitted.
Part III, paragraph 1.2(c), first indentThe references to “a competent authority” and to “the Agency” are to be read as references to the licensing authority and the final two sentences are to be read as omitted.
Part III, paragraph 1.2(c), second indentThe reference to “the Community” is to be read as a reference to the United Kingdom.
Part III, paragraph 1.2(c), third indentThis indent is to be read as follows: “Changes in the content of a Vaccine Antigen Master File must follow the variation procedure in Schedule 10A to the Human Medicines Regulations 2012.”
Part III, paragraph 1.2(c), fourth indentThis indent is to be read as omitted.
Part III, paragraph 1.2(c), fifth indentThis indent is to be read as omitted.
Part III, paragraph 2.1The reference to “applications based on Articles 6(2) and 9” is to be read as a reference to applications in relation to radionuclide generators, radionuclide kits, radionuclide precursors and radiopharmaceuticals.
Part III, paragraph 2.2, fourth paragraphThe reference to “Council Directives 87/18/EEC and 88/320/EEC” is to be read as a reference to the Good Laboratory Practice Regulations 1999.
Part III, paragraph 3, second paragraphThe reference to “Article 15” is to be read as a reference to regulation 103 of the Human Medicines Regulations 2012, the reference to “Article 14(1)” is to be read as a reference to regulation 102 of the Human Medicines Regulations 2012 and the words “referred to in Article 16(1)” are to be read as “which are not registerable homoeopathic medicinal products”.
Part III, paragraph 3(a)The reference to “an official pharmacopoeia of a Member State” is to be read as including the British Pharmacopoeia and any pharmacopoeia used officially in a country that is included in a list published by the licensing authority for that purpose, and the reference to “the traditional names used in each Member State” is to be read as including the traditional name used in the United Kingdom.
Part III, paragraph 3(b), final paragraphThe reference to “an official pharmacopoeia of a Member State” is to be read as including the British Pharmacopoeia.
Part III, paragraph 3, penultimate paragraphThe reference to “Article 14(1)” is to be read as a reference to regulation 102 of the Human Medicines Regulations 2012.
Part III, paragraph 5, first indentThe reference to “an orphan medicinal product in the meaning of Regulation (EC) No 141/2000” is to be read as a reference to a medicinal product to which the orphan criteria are claimed to apply.
Part III, paragraph 5, second indentThe reference to “Article 10(1)(a)(ii)” is to be read as a reference to regulation 54 of the Human Medicines Regulations 2012 and the reference to “Article 5” is to be read as a reference to regulation 167 of the Human Medicines Regulations 2012.
Part IV, paragraph 1, first paragraphThe reference to “point (a) of Article 2(1) of Regulation (EC) No 1394/2007” is to be read as a reference to regulation 2A of the Human Medicines Regulations 2012.
Part IV, paragraph 2This paragraph is to be read as omitted.
Part IV, paragraph 3.1, second paragraphThe reference to “Directive 2004/23/EC” is to be read as a reference to the Human Fertilisation and Embryology Act 1990and the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the reference to “Directive 2002/98/EC” is to be read as a reference to the Blood Safety and Quality Regulations 2005.
Part IV, paragraph 3.3.2.1(a)The reference to “Directive 2004/23/EC” is to be read as a reference to the Human Fertilisation and Embryology Act 1990 and the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
Part IV, paragraph 3.4.1, headingThe reference to “devices as referred to in Article 7 of Regulation (EC) No 1394/2007” is to be read as a reference to medical devices, bio-materials, scaffolds or matrices.
Part IV, paragraph 3.4.2, headingThe reference to “Article 2(1)(d) of Regulation (EC) No 1394/2007” is to be read as a reference to regulation 2A(10) of the Human Medicines Regulations 2012.
Part IV, paragraph 3.4.2(c)The reference to “Commission Directive 2003/32/EC” is to be read as a reference to the Medical Devices Regulations 2002.
Part IV, paragraph 3.4.2(d)The reference to “Directive 93/42/EEC or Directive 90/385/EEC” is to be read as a reference to the Medical Devices Regulations 2002.
Part IV, paragraph 3.4.2, final paragraphThe first sentence is to be read as follows: “The applicant shall make available on request of the licensing authority any information related to the assessment by the notified body which has carried out the assessment referred to in point (d) of this section.”]

Regulation 50(1)

[F1440SCHEDULE 8CU.K.Material to accompany an application for a UK marketing authorisation under the unfettered access route

Textual Amendments

1.  A copy of the application submitted in connection with the granting of the F1441... UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland.U.K.

Textual Amendments

2.  A copy of all material submitted in support of the application for the F1442... UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland.U.K.

Textual Amendments

3.  A copy of the F1443... UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland.]U.K.

Textual Amendments

Regulation 50(4)

SCHEDULE 9U.K.Undertakings by non- [F1444United Kingdom] manufacturers

Textual Amendments

1.  The manufacturer must provide and maintain such staff, premises and plant as are necessary for the carrying out in accordance with the [F1445UK] marketing authorisation of such stages of the manufacture and assembly of the medicinal products to which the authorisation relates as are undertaken by the manufacturer.U.K.

Textual Amendments

2.  The manufacturer must provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of the medicinal products to which the [F1445UK] marketing authorisation relates and which the manufacturer handles, stores or distributes as are necessary to avoid deterioration of the medicinal products.U.K.

Textual Amendments

3.  The manufacturer must provide and maintain a designated quality control department having authority in relation to quality control and being independent of all other departments.U.K.

4.  The manufacturer must conduct all manufacture and assembly operations in such a way as to ensure that the medicinal products to which the [F1445UK] marketing authorisation relates conform with the standards of strength, quality and purity applicable to them under the [F1445UK] marketing authorisation.U.K.

Textual Amendments

5.  The manufacturer must maintain an effective pharmaceutical quality assurance system involving the active participation of the management and personnel of the different services involved.U.K.

6.  Where animals are used in the production of any medicinal product and the [F1445UK] marketing authorisation contains provisions relating to them the manufacturer must arrange for the animals to be housed in premises of such a nature and to be managed in such a way as will facilitate compliance with such provisions.U.K.

Textual Amendments

7.  The manufacturer must make such adequate and suitable arrangements as are necessary for carrying out in accordance with the [F1445UK] marketing authorisation any tests of the strength, quality or purity of the medicinal products to which the [F1445UK] marketing authorisation relates.U.K.

Textual Amendments

8.  The manufacturer must inform the holder of the [F1445UK] marketing authorisation of any material alteration in the premises or plant used in connection with the manufacture or assembly of the medicinal products to which the [F1445UK] marketing authorisation relates or in the operations for which such premises or plant are so used, and of any change since the granting of the relevant [F1445UK] marketing authorisation in respect of any person—U.K.

(a)responsible for supervising the production operations;

(b)responsible for quality control of the medicinal products to which the [F1445UK] marketing authorisation relates;

(c)in charge of the animals from which are derived any substance used in the production of the medicinal products to which the [F1445UK] marketing authorisation relates; or

(d)responsible for the culture of any living tissues used in the manufacture of the medicinal products to which the [F1445UK] marketing authorisation relates.

Textual Amendments

9.—(1) The manufacturer shall keep readily available for inspection by a person authorised by the licensing authority durable records of—U.K.

(a)the details of manufacture and assembly of each batch of the medicinal product to which the [F1445UK] marketing authorisation relates; and

(b)the tests carried out on the product,

in such a form that the records will be easily identifiable from the number of the batch as shown on each container in which the medicinal product is exported from the country where it has been manufactured or assembled.

(2) The manufacturer shall permit the person authorised to take copies of or make extracts from such records.

(3) Such records shall not be destroyed for a period of five years from the date of release of the batch concerned, or one year after the expiry date of the batch, whichever is the later.

Textual Amendments

10.  The manufacturer must keep readily available for examination by a person authorised by the licensing authority samples of—U.K.

(a)each batch of finished products for at least a period of one year after their expiry date; and

(b)starting materials (other than solvents, gases or water) for at least a period of two years after release of the medicinal product of which those materials formed part,

except where the manufacturer is authorised by the licensing authority to destroy such samples earlier.

11.—(1) The manufacturer must implement a system for recording and reviewing complaints in relation to medicinal products to which a [F1445UK] marketing authorisation relates, together with an effective system for recalling promptly and at any time the medicinal products in the distribution network.U.K.

(2) The manufacturer must record and investigate all complaints described in sub-paragraph (1) and must immediately inform the licensing authority of any defect which could result in a recall from sale, supply or export or in an abnormal restriction on such sale, supply or export.

Textual Amendments

12.  The manufacturer must inform the holder of the [F1445UK] marketing authorisation of any material change since the day upon which the authorisation was granted in respect of—U.K.

(a)the facilities and equipment available at each of the premises of the manufacturer for carrying out any stage of the manufacture or assembly of the medicinal products to which the [F1445UK] marketing authorisation relates;

(b)the facilities and equipment available at each of the premises of the manufacturer for the storage of the medicinal products to which the [F1445UK] marketing authorisation relates on, and the distribution of the products from or between, such premises;

(c)any manufacturing operations, not being operations in relation to the medicinal products to which the [F1445UK] marketing authorisation relates, which are carried on by the manufacturer on or near any of the premises on which medicinal products to which the [F1445UK] marketing authorisation relates are manufactured or assembled, and the substances or articles in respect of which such operations are carried on;

(d)the arrangements for the identification and storage of materials and ingredients before and during manufacture or assembly of the medicinal products to which the [F1445UK] marketing authorisation relates and the arrangements for the storage of the products after they have been manufactured or assembled;

(e)the arrangements for ensuring a satisfactory turnover of stocks of medicinal products to which the [F1445UK] marketing authorisation relates;

(f)the arrangements for maintaining production records and records of analytical and other testing procedures applied in the course of manufacture or assembly of the medicinal products to which the [F1445UK] marketing authorisation relates; or

(g)the arrangements for keeping reference samples of materials used in the manufacture of the medicinal products to which the [F1445UK] marketing authorisation relates and reference samples of the medicinal products themselves.

Textual Amendments

Regulation 50G(4)

[F1446SCHEDULE 9AU.K.Meaning of terms used in the orphan criteria and in regulation 58D

Textual Amendments

Prevalence of a condition in [F1447the United Kingdom] U.K.

1.—(1) The following provisions apply for the purposes of establishing, pursuant to regulation 50G(2)(a) and (b)(i), that a medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in [F1448the United Kingdom].

(2) The material provided pursuant to regulation 50G(3) must include—

(a)material which demonstrates that the disease or condition for which the medicinal product would be authorised affects not more than five in 10,000 persons in [F1449the United Kingdom] at the time at which the application for an orphan marketing authorisation is submitted, where this is available;

(b)details of the condition intended to be treated and a justification of the life-threatening or chronically debilitating nature of the condition, supported by scientific or medical references; and

(c)copies of, or references to, relevant scientific literature, as well as copies of information from relevant databases in [F1450the United Kingdom], where available.

(3) If there are no databases as referred to in paragraph (2)(c), information from relevant databases in other countries may be supplied, provided appropriate extrapolations are made.

Textual Amendments

Potential for return on investmentU.K.

2.—(1) The following provisions apply for the purposes of establishing, pursuant to regulation 50G(2)(a) and (b)(ii), that a medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition in [F1451the United Kingdom] and that the medicinal product is unlikely, when marketed, to generate sufficient financial return to justify the necessary investment.

(2) The material provided pursuant to regulation 50G(3) must include—

(a)details of the condition intended to be treated and a justification of the life-threatening or chronically debilitating nature of the condition, supported by scientific or medical references;

(b)details of the costs incurred in connection with the development of the medicinal product;

(c)details of any grants, tax incentives or other cost recovery provisions received in [F1452the United Kingdom] or any other country in relation to the development of the medicinal product;

(d)where the medicinal product is already authorised in [F1453the United Kingdom] for any indication, or where the product is under investigation for one or more other indications, an explanation of, and justification for, the method that is used to apportion the development costs among the various indications;

(e)a statement of and justification for all development costs that the applicant expects to incur after the submission of the application for a UK marketing authorisation;

(f)a statement of and justification for all production and marketing costs that the applicant has incurred in the past and expects to incur in the first ten years that the medicinal product is authorised;

(g)an estimate of and justification for the expected revenues from sales of the medicinal product in [F1454the United Kingdom] and elsewhere during the first ten years that the medicinal product is authorised; and

(h)information on the prevalence and incidence in [F1455the United Kingdom] of the condition for which the medicinal product would be authorised at the time at which the application for an orphan marketing authorisation application is submitted.

(3) The information concerning costs and revenue referred to in sub-paragraph (2) must be determined in accordance with generally accepted accounting principles and must be certified by a person who is a member of a body of accountants which is established in the United Kingdom and which is approved by the licensing authority for the purposes of this paragraph.

Textual Amendments

Existence of other methods of diagnosis, prevention or treatmentU.K.

3.—(1) The following provisions apply for the purposes of establishing, pursuant to regulation 50G(2)(c), that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in [F1456the United Kingdom], or if such method exists, that the medicinal product will be of significant benefit to those affected by the condition.

(2) The material provided pursuant to regulation 50G(3) must include—

(a)details of any existing methods of diagnosis, prevention or treatment of the condition in question that have been authorised in [F1457the United Kingdom], making reference to scientific or medical literature or other relevant information, including information relating to authorised medicinal products, medical devices or other methods of diagnosis, prevention or treatment which are used in [F1457the United Kingdom]; and

(b)a justification as to why either—

(i)the methods referred to in paragraph (a) are not considered satisfactory; or

(ii)the medicinal product for which an orphan marketing authorisation is sought will be of significant benefit to those affected by the condition.

(3) In this paragraph, “significant benefit” means a clinically relevant advantage or a major contribution to patient care.

Textual Amendments

Increased safety or effectiveness and clinical superiorityU.K.

4.—(1) The following provisions apply for the purposes of establishing, pursuant to regulation 58D(6)(c), that a second medicinal product is similar to a medicinal product to which an orphan marketing authorisation relates or is safer or more effective than, or clinically superior to, that product.

(2) The following definitions apply for the purposes of this paragraph—

“clinically superior”, in relation to a medicinal product, means that it is shown to provide a significant therapeutic or diagnostic advantage over and above that provided by an authorised orphan medicinal product in one or more of the following ways—

(a)

greater efficacy;

(b)

greater safety in a substantial portion of the target population, as evidenced where appropriate through comparative clinical trials; or

(c)

in exceptional cases, where neither greater safety nor greater efficacy has been shown, a demonstration that the medicinal product otherwise makes a major contribution to diagnosis or to patient care;

“similar active substance” means an identical active substance, or an active substance with the same principal molecular structural features, but not necessarily all of the same molecular structural features, and which acts via the same mechanism, however, in the case of advanced therapy medicinal products, for which the principal molecular structural features cannot be fully defined, the similarity between two active substances is to be assessed on the basis of the biological and functional characteristics;

“similar medicinal product” means a medicinal product containing a similar active substance or substances as contained in a currently authorised orphan medicinal product, and which is intended for the same therapeutic indication.

(3) For the purposes of the definition of “clinically superior” in relation to a medicinal product which shows that superiority by means of greater efficacy, this is to be assessed by the effect on a clinically meaningful endpoint in adequate and well controlled clinical trials, representing the same kind of evidence needed to support a comparative efficacy claim for two different medicinal products.

(4) The clinical trials referred to in paragraph (3) should be direct comparative clinical trials, unless comparisons based on other endpoints, including surrogate endpoints, can be justified.

(5) Paragraphs 5 to 8 make further provision about the definition of “similar active substance” in relation to certain types of product.

5.—(1) This paragraph applies for the purposes of the definition of “similar active substance” in relation to chemical medicinal products.U.K.

(2) The principal molecular structural features are the relevant structural components of an active substance, which may be the whole or part of the molecule.

(3) Whether the principal molecular structural features are the same between two or more molecules will be identified by comparison of their structures.

(4) Isomers, mixtures of isomers, complexes, esters, ethers, salts and derivatives of the original active substance, or an active substance that differs from the original active substance only with respect to minor changes in the molecular structure, such as a structural analogue, are to be considered similar.

(5) Synthetic polynucleotide substances, single or double stranded, consisting of two or more distinct nucleotides where—

(a)the difference in the nucleotide sequence of the purine and pyrimidine bases or their derivatives is not major, are to be considered similar, therefore for antisense or interfering nucleotide substances, addition, substitution or deletion of a nucleotide not significantly affecting the kinetics of hybridisation to the target are usually to be considered similar; and

(b)the difference in structure related to modifications of the ribose or deoxyribose backbone sugars or to the replacement of the backbone sugars by synthetic analogues usually result in substances being considered similar, and for antisense or interfering nucleotide substances, changes in the ribose or deoxyribose backbone sugars not significantly affecting the kinetics of hybridisation to the target are usually to be considered similar.

6.—(1) This paragraph applies for the purposes of the definition of “similar active substance” in relation to biological medicinal products other than advanced therapy medicinal products.U.K.

(2) The principal molecular structural features are the structural components of an active substance that are relevant for the functional characteristics of that substance.

(3) The principal molecular structural features may be composed of a therapeutic moiety or a therapeutic moiety in combination with an additional structural element significantly contributing to the functional characteristics of the active substance.

(4) An additional structural element as described in paragraph (3) may be conjugated, fused or linked by other means to the therapeutic moiety or may be an extension of the therapeutic moiety protein backbone by additional amino acids.

(5) Substances with structural elements for which similar methods of modification or conjugation technology are used usually result in similar substances.

(6) Biological active substances which differ from the original biological substance only with respect to minor changes in the molecular structure are to be considered similar.

(7) In relation to proteinaceous substances—

(a)if the difference in structure between them is due to post-translational events, such as different glycosylation patterns, substances are usually to be considered similar; however, exceptionally some post-translational modifications may result in a non-similar substance if there is significant effect on the functional characteristics of the substance;

(b)if the difference in the amino acid sequence is not major, substances are usually to be considered similar; therefore two pharmacologically related protein substances of the same group, for example, having differences related to N-terminal methionine, naturally extracted as opposed to recombinant nucleic acid-derived proteins or other minor variants, are usually to be considered similar; however, the addition of a structural element may result in substances not being considered similar if this significantly affects the functional characteristics of the substance;

(c)monoclonal antibodies binding to the same target epitope are usually to be considered similar; however, two monocloncal antibody conjugates or fusion proteins may be considered not to be similar if either the Complementary Determining Region sequences of the antibody or the additional structural element of the conjugated monoclonal antibody is different.

(8) In relation to polysaccharide substances—

(a)if the substances have identical saccharide repeating units, even if the number of units varies, the substances are usually to be considered similar; and

(b)a conjugated polysaccharide vaccine compared to a non-conjugated polysaccharide vaccine containing the same antigen is considered not to be similar.

7.—(1) This paragraph applies for the purposes of the definition of “similar active substance” in relation to advanced therapy medicinal products.U.K.

(2) In relation to cell-based advanced therapy medicinal products, these are not to be considered similar if—

(a)there are differences in starting materials or the final composition of the product which have a significant impact on the biological characteristics or biological activity relevant for the intended therapeutic effect or safety attributes of the product, and the different source of the starting materials, such as in the case of autologous advanced therapy medicinal products, is not sufficient to support a claim that two products are not similar; or

(b)there are differences in the manufacturing technology having a significant impact on the biological characteristics or the biological activity relevant for the intended therapeutic effect or safety attributes of the product.

(3) In relation to gene therapy medicinal products—

(a)two gene therapy medicinal products are not to be considered similar when there are differences in the therapeutic sequence, viral vector, transfer system, regulatory sequences or manufacturing technology which significantly affect the biological characteristics or biological activity relevant for the intended therapeutic effect or safety attributes of the product; and

(b)differences in the therapeutic sequence with a significant impact on the intended therapeutic effect are not sufficient to support a claim that two gene therapy medicinal products are not similar.

(4) The considerations in paragraphs (2) and (3) also apply in relation to genetically modified cells.

8.—(1) This paragraph applies for the purposes of the definition of “similar active substance” in relation to radiopharmaceuticals.U.K.

(2) The same radiopharmaceutical active substance, or one differing from the original in radionuclide, ligand, site of labelling or molecule-radionuclide coupling mechanism linking the molecule and radionuclide which acts via the same mechanism, are to be considered similar substances.]

Regulations 50(6)(g) and 64(5)(b)

SCHEDULE 10U.K.National homoeopathic products

Meaning of “national homoeopathic product”U.K.

1.—(1) In this Schedule “national homoeopathic product” means a homoeopathic medicinal product that—U.K.

(a)is not a registrable homoeopathic medicinal product; and

(b)is indicated for the relief or treatment of minor symptoms or minor conditions in human beings.

(2) For this purpose symptoms or conditions are minor if they can ordinarily and with reasonable safety be relieved or treated without the supervision or intervention of a doctor.

General requirements for applicationU.K.

2.—(1) An application for the grant of a UK marketing authorisation for a national homoeopathic product does not need be made in accordance with, and an applicant for such an authorisation does not need to comply with—U.K.

(a)paragraphs (b) and (c) of paragraph 10 of Schedule 8 (requirement to submit results of pre-clinical tests and clinical trials);

(b)the guidance referred to in paragraph (1) in the “Introduction and general principles” of Annex 1 to the 2001 Directive in so far as it relates to the requirement to submit the results of pre-clinical tests and clinical trials; or

(c)the following provisions of Part 1 of that Annex—

(i)sections 2.4 to 2.7 (non-clinical and clinical overview and non-clinical and clinical summaries),

(ii)section 4 (Module 4: non-clinical reports), or

(iii)section 5 (Module 5: clinical study reports).

(2) The applicant must submit with the application—

(a)particulars and documents relating to the safety of the product in accordance with paragraph 3 (subject to paragraph 4); and

(b)particulars and documents relating to the efficacy of the product in accordance with paragraph 5.

(3) References in Annex 1 to the 2001 Directive to non-clinical reports, non-clinical documentation and non-clinical data apply in relation to the application as if they were references to the particulars and documents referred to in paragraph 3.

(4) References in that Annex to clinical study reports, clinical documentation and clinical data apply in relation to the application as if they were references to the particulars and documents referred to in paragraph 5.

Requirement to submit safety dataU.K.

3.—(1) The applicant must submit data as to the safety of the product unless paragraph 4 applies.U.K.

(2) The data must include information about the following aspects of the safety of the product—

(a)pharmacology;

(b)pharmacokinetics; and

(c)toxicology, including its toxicity, genotoxicity, reproductive and developmental toxicity and local tolerance.

(3) The data must be scientific data unless sub-paragraph (5) applies.

(4) For this purpose “scientific data” means—

(a)study reports in relation to the product;

(b)published scientific data; or

(c)a combination of data within paragraph (a) and data within paragraph (b).

(5) The applicant may submit other data in relation to an aspect of the safety of the product if having made reasonable attempts to obtain scientific data in relation to that aspect—

(a)the applicant is satisfied that no such scientific data is available; or

(b)the applicant thinks that such scientific data as is available may be inadequate to demonstrate an acceptable level of safety in relation to that aspect.

(6) The applicant must include with the data—

(a)a table of contents; and

(b)an evaluation of the scientific data, including an explanation of how it demonstrates an acceptable level of safety.

(7) If the applicant submits data other than scientific data, the applicant must include—

(a)a statement that sub-paragraph (5) applies; and

(b)an explanation of why an acceptable level of safety can be demonstrated despite the lack of scientific data.

Exceptions to requirement to submit safety dataU.K.

4.—(1) The applicant does not need to submit data as to the safety of the product if—U.K.

(a)condition A, B or C is met; and

(b)the application is accompanied by a written statement that the condition is met.

(2) Condition A is that the product—

(a)is derived from a homoeopathic stock that is commonly present in food; and

(b)is intended to be administered orally.

(3) For this purpose “food” has the meaning given by Council Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety M80.

(4) Condition B is that—

(a)the product is derived from a homoeopathic stock from which is derived a medicinal product that has a [F1458UK] marketing authorisation, certificate of registration or traditional herbal registration (“the source product”);

(b)the source product is subject to general sale within the meaning of regulation 5(1); and

(c)the product has the same route of administration and the same degree of dilution as the source product.

(5) Condition C is that the product is derived from a homoeopathic stock that—

(a)is diluted to at least 1 in 1024 of the stock; and

(b)is not a material derived from a human or animal source.

Textual Amendments

Marginal Citations

M80OJ No L 31, 1.2.2002, p.1, as last amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p. 14).

Requirement to submit efficacy dataU.K.

5.—(1) The applicant must submit data as to the efficacy of the product.U.K.

(2) The data must consist of at least one the following—

(a)study reports in relation to the product;

(b)published scientific literature; or

(c)the results of investigations (commonly known as homoeopathic provings) consisting of the administration of a substance to a human subject to ascertain the symptoms it produces.

(3) The applicant must include with the data—

(a)a table of contents; and

(b)an evaluation of the data, including an explanation of how the data establishes that the product has a recognised level of efficacy in the therapeutic indication for which authorisation is sought.

Regulation 65C(2)

[F1459SCHEDULE 10AU.K.Variations to a UK marketing authorisation

Textual Amendments

InterpretationU.K.

1.  In this Schedule—

“change of, or addition of a new, route of administration”, in relation to parenteral administration, includes any change or addition as between intra-arterial, intra-venous, intramuscular, subcutaneous and any other route;

“extension of a UK marketing authorisation” or “extension” means a variation which consists of—

(a)

a change to one or more active substances that involves—

(i)

replacement of a chemical active substance by a different salt, ester, complex or derivative, with the same therapeutic moiety, where the efficacy and safety characteristics are not significantly different,

(ii)

replacement by a different isomer, a different mixture of isomers, of a mixture by an isolated isomer (for example, racemate by a single enantiomer), where the efficacy and safety characteristics are not significantly different,

(iii)

replacement of a biological active substance with one of a slightly different molecular structure where the efficacy and safety characteristics are not significantly different, with the exception of changes to the active substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza,

(iv)

modification of the vector used to produce the antigen or the source material, including a new master cell bank from a different source, where the efficacy and safety characteristics are not significantly different,

(v)

a new ligand or coupling mechanism for a radiopharmaceutical, where the efficacy and safety characteristics are not significantly different, or

(vi)

change to the extraction solvent or the ratio of herbal drug to herbal drug preparation where the efficacy and safety characteristics are not significantly different; or

(b)

a change to strength, pharmaceutical form and route of administration that involves—

(i)

change of bioavailability,

(ii)

change of pharmacokinetics, for example change in rate of release,

(iii)

change or addition of a new strength or potency,

(iv)

change or addition of a new pharmaceutical form, or

(v)

change or addition of a new route of administration;

“holder” means UK marketing authorisation holder;

“major variation of type II” means a variation which is not an extension and which may have a significant impact on the quality, safety or efficacy of the medicinal product concerned namely—

(a)

variations related to the addition of a new therapeutic indication or to the modification of an existing one;

(b)

variations related to significant modifications of the summary of product characteristics due in particular to new quality, pre-clinical, clinical or pharmacovigilance findings;

(c)

variations related to changes outside the range of approved specifications, limits or acceptance criteria;

(d)

variations related to substantial changes to the manufacturing process, formulation, specifications or impurity profile of the active substance or finished medicinal product which may have a significant impact on the quality, safety or efficacy of the medicinal product;

(e)

variations related to modifications in the manufacturing process or sites of the active substance for a biological medicinal product;

(f)

variations related to the introduction of a new design space or the extension of an approved one, where the design space has been developed in accordance with international scientific guidelines; or

(g)

variations related to changes to the active substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza;

“minor variation of type IA” means a variation which has only a minimal impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned namely—

(a)

variations of purely administrative nature that are related to the identity and contact details of—

(i)

the holder,

(ii)

the manufacturer or supplier of any starting material, reagent, intermediate, active substance used in the manufacturing process or finished product;

(b)

variations related to the identity, location and contact details of the qualified person for pharmacovigilance, or the location of the pharmacovigilance system master file;

(c)

variations related to the deletion of any manufacturing site, including for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place;

(d)

variations related to minor changes to an approved physico-chemical test procedure, where the updated procedure is demonstrated to be at least equivalent to the former test procedure, appropriate validation studies have been performed and the results show that the updated test procedure is at least equivalent to the former;

(e)

variations related to changes made to the specifications of the active substance or of an excipient in order to comply with an update of the relevant monograph of the European Pharmacopoeia or of the British Pharmacopoeia, where the change is made exclusively to comply with the pharmacopoeia and the specifications for product specific properties are unchanged;

(f)

variations related to changes in the packaging material not in contact with the finished product, which do not affect the delivery, use, safety or stability of the medicinal product;

(g)

variations related to the tightening of specification limits, where the change is not a consequence of any commitment from previous assessment to review specification limits and does not result from unexpected events arising during manufacture;

“minor variation of type IB” means a variation which is not a minor variation of type IA, a major variation of type II nor an extension; and

“urgent safety restriction” means an interim change in the terms of the UK marketing authorisation due to new information having a bearing on the safe use of the medicinal product.

Classification of variationsU.K.

2.—(1) Except where sub-paragraph (2) applies, a variation which is not an extension, and whose classification is undetermined after—

(a)application of the provisions in this Schedule; and

(b)taking into account—

(i)the guidance referred to in regulation 65C(4) or (6) as the case may be), and

(ii)where relevant, any recommendations delivered pursuant to paragraph 3,

is to be treated by the licensing authority as a minor variation of type IB.

(2) The licensing authority must treat a variation that would otherwise fall within sub-paragraph (1) as a major variation of type II in the following cases—

(a)upon request from the holder when submitting the variation; or

(b)where the licensing authority concludes, following the assessment of validity of a notification in accordance with paragraph 7(1), and taking into account the recommendations given under paragraph 3, that the variation may have a significant impact on the quality, safety or efficacy of the medicinal product concerned.

Licensing authority recommendation on unclassified variationsU.K.

3.—(1) Prior to the submission of a variation whose classification is not provided for in this Schedule—

(a)the holder may request a recommendation on the classification of the variation from the licensing authority; and

(b)the licensing authority must notify the holder of its recommendation within 45 days of that request, beginning with the date on which the request is received by the licensing authority.

(2) The 45-day period referred to in sub-paragraph (1)(b) may be extended by 25 days where the licensing authority deems it necessary.

Variations leading to the revision of product informationU.K.

4.  Where a variation leads to the revision of the summary of product characteristics, labelling or the package leaflet, the revision must be considered by the licensing authority as part of that variation.

Grouping of variationsU.K.

5.—(1) Except where sub-paragraph (2) applies, where several variations are notified or applied for, a separate notification or application in accordance with paragraph 6, 7, 8 or 11 of this Schedule is to be submitted in respect of each variation sought.

(2) This sub-paragraph applies—

(a)where one or more of the same minor variations of type IA to the terms of one or more UK marketing authorisations owned by the same holder are notified at the same time to the licensing authority, in which case a single notification as referred to in paragraph 6 may cover all such variations;

(b)where several variations to the terms of the same UK marketing authorisation are submitted at the same time, a single submission may cover all such variations provided that the variations concerned fall within one of the relevant circumstances specified in sub-paragraph (3);

(c)where one or more of the same variation to the terms of one or more UK marketing authorisations held by the same holder are submitted at the same time and the variations do not fall within paragraph (a) or (b), a single submission may cover all such variations provided that the licensing authority agrees to such single submission.

(3) The relevant circumstances are—

(a)one of the variations in the group is an extension of the UK marketing authorisation;

(b)one of the variations in the group is a major variation of type II, but all other variations in the group are variations which are consequential to this major variation of type II;

(c)one of the variations in the group is a minor variation of type IB, but all other variations in the group are minor variations which are consequential to this minor variation of type IB;

(d)all variations in the group relate solely to changes of an administrative nature to the summary of product characteristics, labelling and package leaflet or insert;

(e)all variations in the group are changes to an Active Substance Master File, Vaccine Antigen Master File or Plasma Master File;

(f)all variations in the group relate to a project intended to improve the manufacturing process and the quality of the medicinal product concerned or one or more of its active substances;

(g)all variations in the group are changes affecting the quality of a human pandemic influenza vaccine;

(h)all variations in the group are changes to the pharmacovigilance system referred to in paragraph 12 of Schedule 8;

(i)all variations in the group are consequential to a given urgent safety restriction and submitted in accordance with paragraph 14;

(j)all variations in the group relate to the implementation of a given class labelling;

(k)all variations in the group are consequential to the assessment of a given periodic safety update report;

(l)all variations in the group are consequential to a given post-authorisation study conducted under the supervision of the holder;

(m)all variations in the group are consequential to a condition imposed under regulation 59(4C) or (4D).

(4) The submission referred to in sub-paragraph (2)(b) and (c) must be made by means of the following—

(a)a single notification in accordance with paragraph 7 where at least one of the variations is a minor variation of type IB and the remaining variations are minor variations;

(b)a single application in accordance with paragraph 8 where at least one of the variations is a major variation of type II and none of the variations is an extension; or

(c)a single application in accordance with paragraph 11 where at least one of the variations is an extension.

Notification procedure for minor variations of type IAU.K.

6.—(1) Subject to sub-paragraph (2), where a minor variation of type IA is made, the holder must submit to the licensing authority a notification containing the elements listed in paragraph 9 within 12 months, beginning with the date on which the variation is implemented by the holder.

(2) The notification referred to in sub-paragraph (1) must be submitted immediately after the implementation of the variation in the case of minor variations requiring immediate notification for the continuous supervision of the medicinal product concerned.

(3) Within 30 days beginning with the date on which the licensing authority receives a notification under this paragraph, the measures provided for in paragraph 10 are to be taken.

Notification procedure for minor variations of type IBU.K.

7.—(1) The holder must for minor variations of type IB submit to the licensing authority a notification containing the elements listed in paragraph 9, and if the notification contains those elements, the licensing authority must acknowledge receipt of a valid notification.

(2) If within 30 days beginning with the date on which the licensing authority acknowledges receipt of a valid notification, the licensing authority has not sent the holder an unfavourable opinion, the notification is deemed to be accepted by the licensing authority.

(3) Where the notification is accepted by the licensing authority, the measures provided for in paragraph 10 are to be taken.

(4) Where the licensing authority is of the opinion that the notification cannot be accepted, it must inform the holder, stating the grounds on which its unfavourable opinion is based.

(5) Within 30 days beginning with the date on which the holder receives the unfavourable opinion, the holder may submit to the licensing authority an amended notification in order to take due account of the grounds laid down in that opinion.

(6) If the holder does not amend the notification in accordance with sub-paragraph (5), the notification is deemed to be rejected.

(7) Where an amended notification has been submitted, the licensing authority must assess it within 30 days beginning with the date on which it receives the amended notification, and the measures provided for in paragraph 10 are to be taken.

(8) This paragraph does not apply where—

(a)a type IB variation request is submitted in a grouping that includes a variation type II and does not contain an extension: in such a case, the prior approval procedure in paragraph 8 applies; or

(b)a type IB variation request is submitted in a grouping that includes an extension: in such a case, the procedure in paragraph 11 applies.

Prior approval procedure for major variations of type IIU.K.

8.—(1) The holder must submit to the licensing authority an application containing the elements listed in paragraph 9, and if the application contains those elements, the licensing authority must acknowledge receipt of a valid application.

(2) Subject to sub-paragraph (3), within 60 days beginning with the date on which the licensing authority acknowledges receipt of a valid application under sub-paragraph (1), the licensing authority must conclude the assessment.

(3) The licensing authority may—

(a)reduce the period referred to in sub-paragraph (2), having regard to the urgency of the matter; or

(b)extend it to 90 days for—

(i)variations concerning a change to, or addition of, therapeutic indications, or

(ii)grouping of variations in accordance with paragraph 5(2)(c).

(4) Within the periods referred to in sub-paragraph (2) or (3), the licensing authority may request the holder to provide supplementary information within a time limit that it specifies, in which case—

(a)the procedure is suspended from the date on which such a request is made until the date on which that supplementary information has been provided; and

(b)the licensing authority may extend the period referred to in sub-paragraph (2) by the period for which the procedure is so suspended.

(5) Within 30 days beginning with the date on which the licensing authority concludes its assessment of the application, the measures provided for in paragraph 10 are to be taken.

(6) This paragraph does not apply where a type II variation request is submitted in a grouping that includes an extension: in such case, the procedure in paragraph 11 applies.

Elements to be submittedU.K.

9.  An application or notification under this Schedule must include—

(a)a list of all the UK marketing authorisations affected by the notification or application;

(b)a description of all the variations submitted, including—

(i)in the case of minor variations of type IA, the date of implementation for each variation described,

(ii)in the case of minor variations of type IA which do not require immediate notification, a description of all minor variations of type IA made in the last 12 months to the terms of any affected UK marketing authorisation, such period beginning with the day on which the application or notification is submitted, and which have not been already notified,

(iii)any documents specified in guidance published under regulation 65C(4) or (6) (as the case may be), insofar as relevant to the type of variation notified or applied for,

(iv)where a variation leads to or is the consequence of other variations to the terms of the same UK marketing authorisation, a description of the relationship between those variations, and

(v)the relevant fee provided for in the Fees Regulations.

Measures to close the procedures specified in paragraphs 6 to 8U.K.

10.  Where reference is made to this paragraph, the licensing authority must take the following measures—

(a)inform the holder as to whether the variation is accepted or rejected;

(b)where the variation is rejected, inform the holder of the grounds for the rejection; and

(c)where necessary, amend the decision granting the UK marketing authorisation in accordance with the accepted variation within the time limit laid down in paragraph 15.

Extensions of marketing authorisationsU.K.

11.—(1) An application for an extension of a UK marketing authorisation must be assessed by the licensing authority in accordance with the same or equivalent procedure that applied under Part 5 to the initial UK marketing authorisation to which it relates.

(2) An extension must either be granted a UK marketing authorisation in accordance with the same or equivalent procedure as for the granting of the initial UK marketing authorisation to which it relates, or be included in that initial UK marketing authorisation.

Human influenza vaccinesU.K.

12.—(1) By way of exception from paragraph 8, the procedure laid down in sub-paragraphs (2) to (4) applies to the examination of variations concerning changes to the active substance for the purposes of the annual update of a human influenza vaccine.

(2) The holder must submit to the licensing authority an application containing the elements listed in paragraph 9, and if it does so, the licensing authority must acknowledge receipt of a valid application.

(3) The licensing authority must assess the application submitted, and where it deems it necessary, the licensing authority may request additional data from the holder in order to complete its assessment.

(4) The licensing authority must—

(a)adopt a decision within 45 days, beginning with the date on which it receives a valid application; and

(b)take the measures provided for in paragraph 10.

(5) The 45-day period referred to in sub-paragraph (4) is to be suspended from the date on which the additional data referred to in sub-paragraph (3) is requested until the date on which that data is received by the licensing authority.

Pandemic situation with respect to human influenzaU.K.

13.—(1) By way of exception to the provisions of this Schedule, where a pandemic situation with respect to human influenza is duly recognised by the World Health Organisation, or the licensing authority, the licensing authority may exceptionally and temporarily accept a variation to the terms of a UK marketing authorisation for a human influenza vaccine, where certain non-clinical or clinical data are missing.

(2) Where a variation is accepted pursuant to sub-paragraph (1), the holder must submit the missing non-clinical and clinical data within a time limit set by the licensing authority.

Urgent safety restrictionsU.K.

14.—(1) Where, in the event of a risk to public health, the holder takes urgent safety restrictions on its own initiative, it must forthwith notify the licensing authority.

(2) If the licensing authority has not raised objections within 24 hours following receipt of that information, the urgent safety restrictions are deemed to be accepted.

(3) In the event of a risk to public health in relation to a medicinal product, the licensing authority may impose urgent safety restrictions on the holder of the UK marketing authorisation in respect of that product.

(4) Where an urgent safety restriction is taken by the holder, or imposed by the licensing authority, the holder must submit the corresponding application for variation within 15 days beginning with the date on which that restriction is initiated.

Amendments to the decision granting the marketing authorisationU.K.

15.—(1) Amendments to the decision granting the UK marketing authorisation resulting from the procedures laid down in this Schedule must be made by the licensing authority—

(a)in the case of major variations of type II, within two months, beginning with the date on which the information referred to in paragraph 10(a) is sent to the holder; or

(b)in the other cases, within six months, beginning with the date on which the information referred to in paragraph 10(a) is sent to the holder,

and the licensing authority must notify the holder of the amended decision without delay.

(2) The statement indicating compliance with the agreed completed paediatric investigation plan provided for under regulation 58A(2)(a) must be included within the technical dossier of the UK marketing authorisation, and the licensing authority must confirm to the holder that it is so included when it notifies the holder under paragraph 10(a).

Implementation of variationsU.K.

16.—(1) Minor variations of type IA may be implemented any time before completion of the procedures laid down in paragraph 6.

(2) Where a notification concerning one or several minor variations of type IA is rejected, the holder must cease to apply the rejected variation immediately after receipt of the information referred to in paragraph 10(a).

(3) Minor variations of type IB may only be implemented after the licensing authority has informed the holder that it has accepted the notification pursuant to paragraph 7, or after the notification is deemed accepted pursuant to paragraph 7(2).

(4) Major variations of type II may only be implemented after the licensing authority has informed the holder that it has accepted the variation pursuant to paragraph 10.

(5) An extension may only be implemented after the licensing authority has amended the decision granting the marketing authorisation and notified the holder accordingly.

(6) Urgent safety restrictions, and variations which are related to safety issues, must be implemented within a time frame agreed by the holder and the licensing authority.

Continuous monitoringU.K.

17.  Where requested to do so by the licensing authority, the holder must supply to the licensing authority without delay any information related to the implementation of a given variation.]

Regulations 58(5);59(7); 60(11);66(8); 68(12); 104(4);105(9); 108(8); 110(9);130(11); 133(8); and 137

SCHEDULE 11U.K.Advice and representations

PART 1U.K.General procedures

Application of this PartU.K.

1.—(1) This Part of this Schedule applies to—U.K.

(a)an application for the grant of a UK marketing authorisation, certificate of registration or traditional herbal registration;

(b)an application to renew a UK marketing authorisation, certificate of registration or traditional herbal registration; F1460...

(c)a proposal to revoke, vary or suspend a UK marketing authorisation, certificate of registration or traditional herbal registration (including variation by the variation or removal of a condition to which a UK marketing authorisation or a certificate of registration is subject) other than a proposal to vary the authorisation, certificate or registration on the application of or by agreement with its holder [F1461; and

(d)a proposal to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.]

[F1462(1A) Paragraphs 12 and 13 of this Part also apply to—

(a)an application for the grant of a parallel import licence;

(b)an application to renew a parallel import licence;

(c)a proposal to revoke, vary or suspend a parallel import licence (including variation by the variation or removal of a condition to which a parallel import licence is subject) other than a proposal to vary the licence on the application of or by agreement with its holder; and

(d)a refusal to vary a parallel import licence following an application for a variation by the holder.]

[F1463(2) In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.]

Textual Amendments

Requirement to consult the appropriate committeeU.K.

2.—(1) The licensing authority must consult the appropriate committee if the authority proposes on grounds relating to safety, quality or efficacy—U.K.

(a)to refuse to grant or renew a UK marketing authorisation or traditional herbal registration in response to the application; or

(b)to revoke, vary or suspend a UK marketing authorisation or traditional herbal registration.

(2) The licensing authority must consult the appropriate committee if the authority proposes on grounds relating to safety or quality—

(a)to refuse to grant or renew a certificate of registration in response to the application; or

(b)to revoke, vary or suspend a certificate of registration.

[F1464(2A) The licensing authority must consult the appropriate committee if the authority proposes to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.]

(3) This paragraph is subject to paragraphs 3 and 4 (exceptions to requirement to consult).

(4) In this Schedule “the appropriate committee” in relation to any function means whichever of the bodies listed in paragraph (5) the licensing authority considers to be the appropriate body to perform that function.

(5) Those bodies are—

(a)the Commission; and

(b)any expert committee appointed by the licensing authority.

Textual Amendments

Exceptions to requirement to consultU.K.

3.—(1) Paragraph 2 does not apply to a proposal to refuse to grant or renew a UK marketing authorisation, certificate of registration or traditional herbal registration [F1465, or to a proposal to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation,] if—U.K.

(a)the licensing authority has asked the applicant to supply information that the licensing authority thinks is relevant to enable the application to be determined [F1466or the decision to be made]; and

(b)the information has not been supplied to the authority within the relevant period.

(2) The relevant period is—

(a)where the licensing authority has completed its initial full assessment of the application, the period of six months beginning with the date when the authority asked the applicant to supply the information mentioned in sub-paragraph (1); or

(b)where the licensing authority has completed its assessment of any supplemental information, the period of three months beginning with the date when the authority asked the applicant to supply the information mentioned in sub-paragraph (1).

(3) The licensing authority may extend the relevant period if—

(a)the applicant asks it to do so;

(b)the applicant provides the grounds for that request; and

(c)the licensing authority thinks that the grounds are exceptional.

Textual Amendments

4.—(1) Paragraph 2 does not apply to a proposal to suspend a UK marketing authorisation, certificate of registration or traditional herbal registration if the licensing authority thinks that, in the interests of safety, it is necessary to suspend the authorisation, certificate or registration with immediate effect for not more than three months.U.K.

(2) In that event the licensing authority must report the suspension to the appropriate committee forthwith.

(3) Sub-paragraph (4) applies if, following a suspension to which this paragraph applies—

(a)the licensing authority thinks that the authorisation, certificate or registration should be further suspended, or varied or revoked; or

(b)the appropriate committee advises that the authorisation, certificate or registration should be further suspended, or varied or revoked.

(4) The provisions of this Part of this Schedule (including this paragraph) apply accordingly to the suspension, variation or revocation.

Provisional opinion against authorisationU.K.

5.—(1) If the appropriate committee is consulted under paragraph 2(1) it may give a provisional opinion that on grounds relating to safety, quality or efficacy—U.K.

(a)it may be unable to advise the licensing authority to grant or renew the UK marketing authorisation or traditional herbal registration;

(b)it may be unable to advise the licensing authority to grant the authorisation or registration unless—

(i)it contains terms other than those in the application, or

(ii)it is granted subject to conditions; or

(c)it may have to advise the licensing authority to revoke, vary or suspend the authorisation or registration.

(2) If the Commission is consulted under paragraph 2(2), it may give a provisional opinion that, on grounds relating to safety or quality—

(a)it may be unable to advise the licensing authority to grant or renew the certificate of registration;

(b)it may be unable to advise the licensing authority to grant the certificate unless—

(i)it contains terms other than those in the application, or

(ii)it is granted subject to conditions; or

(c)it may have to advise the licensing authority to revoke, vary or suspend the certificate.

[F1467(2A) If the appropriate committee is consulted under paragraph 2(2A), it may give a provisional opinion that it may be unable to advise the licensing authority to decide that the orphan criteria are met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.]

(3) The appropriate committee must notify the applicant for the grant or renewal [F1468 , the applicant intending to demonstrate that the orphan criteria are met in relation to a medicinal product,] or (as the case may be) the holder of the authorisation, certificate or registration in writing of its provisional opinion.

Textual Amendments

Opportunity to make representationsU.K.

6.—(1) An applicant or holder notified under paragraph 5 may, by notice in writing to the appropriate committee, request the opportunity to make written or oral representations to the appropriate committee.U.K.

(2) The applicant or holder must make the request within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

Written representationsU.K.

7.—(1) If the applicant or holder requests the opportunity to make written representations, the applicant or holder must provide the appropriate committee with those representations and any documents on which the applicant or holder wishes to rely in support of them—U.K.

(a)before the end of the period of six months beginning with the date of the request; or

(b)before the end of such shorter period as the appropriate committee may specify in the notification under paragraph 5.

(2) The appropriate committee may at the request of the applicant or holder extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 6.

(3) The applicant or holder may submit additional representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) The appropriate committee must—

(a)take the representations made under this paragraph into account; and

(b)report its findings and advice to the licensing authority together with the reasons for that advice.

Oral representationsU.K.

8.—(1) If the applicant or holder requests the opportunity to make oral representations, the applicant or holder must provide the appropriate committee with a written summary of those representations and any documents on which the applicant or holder wishes to rely in support of them—U.K.

(a)before the end of the period of six months beginning with the date of the request; or

(b)before the end of such shorter period as the appropriate committee may specify in the notification under paragraph 5.

(2) The appropriate committee may at the request of the applicant or holder extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 6.

(3) The applicant or holder may submit additional written representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) After receiving the summary and any other documents provided under this paragraph, the appropriate committee must arrange for the applicant or holder to make oral representations at a hearing before the committee.

(5) The appropriate committee must—

(a)take the representations made under this paragraph into account; and

(b)report its findings and advice to the licensing authority together with the reasons for that advice.

Other decisions of the appropriate committeeU.K.

9.—(1) This paragraph applies if the applicant or holder—U.K.

(a)does not request the opportunity to make written or oral representations to the appropriate committee within the period mentioned in paragraph 6;

(b)requests the opportunity to make written representations, but fails to make those written representations within the period for doing so; or

(c)requests the opportunity to make oral representations, but—

(i)fails to provide a summary of those representations or the documents in support of them within the period for doing so, or

(ii)fails to make oral representations at a hearing before the appropriate committee.

(2) The appropriate committee must notify the licensing authority of that fact.

Decision of licensing authorityU.K.

10.—(1) After receiving the appropriate committee's report under paragraph 7 or 8 or notification under paragraph 9 the licensing authority must—U.K.

(a)decide whether to grant or renew the UK marketing authorisation, certificate of registration or traditional herbal registration;

(b)decide whether to grant or renew the authorisation, certificate or registration in accordance with the application; F1469...

(c)decide whether to proceed with its proposal to revoke, vary or suspend the authorisation, certificate or registration [F1470; or

(d)decide whether to proceed with its proposal to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation,]

as the case may be.

(2) If the appropriate committee has given a report under paragraph 7 or 8, the licensing authority must take the report into account in making its decision.

(3) The licensing authority must notify the applicant or holder of—

(a)its decision; and

(b)any advice given to it by the appropriate committee and the reasons for that advice.

Textual Amendments

Right to review after paragraph 10 notificationU.K.

11.—(1) A person to whom a notification is given under paragraph 10 may notify the licensing authority in writing that the person wishes the licensing authority to submit the decision to review upon oral representations.U.K.

(2) The person must give the notification within the period of 28 days beginning with the day on which the notification under paragraph 10 is given or such longer period as the licensing authority may allow.

(3) The review must be conducted in accordance with Schedule 5.

(4) This paragraph does not apply if—

(a)the person has not made any representations in accordance with paragraph 7 or 8; and

(b)the decision of the licensing authority is in accordance with the advice of the appropriate committee.

Licensing authority decisions in other casesU.K.

12.—(1) This paragraph applies if the appropriate committee has not been consulted under paragraph 2(1) because the licensing authority proposes on grounds not relating to safety, quality or efficacy—U.K.

(a)to refuse to grant or renew a UK marketing authorisation [F1471, parallel import licence] or traditional herbal registration in response to the application;

(b)to grant or renew a UK marketing authorisation [F1471, parallel import licence] or traditional herbal registration otherwise than in accordance with the application; or

(c)to revoke, vary or suspend a UK marketing authorisation [F1471, parallel import licence] or traditional herbal registration.

(2) This paragraph also applies if, having been consulted under paragraph 2(1), the appropriate committee has not given a provisional opinion in the terms described in paragraph 5(1), and the licensing authority proposes—

(a)to determine the application for the UK marketing authorisation or traditional herbal registration in a way that differs from the appropriate committee's advice;

(b)to revoke, vary or suspend the authorisation or registration against such advice; or

(c)on grounds not relating to safety, quality or efficacy—

(i)to refuse to grant or renew the authorisation or registration,

(ii)to grant or renew the authorisation or registration otherwise than in accordance with the application, or

(iii)to revoke, vary or suspend the authorisation or registration.

(3) This paragraph also applies if the appropriate committee has not been consulted under paragraph 2(2) because the licensing authority proposes on grounds not relating to safety or quality—

(a)to refuse to grant or renew a certificate of registration in response to the application;

(b)to grant or renew a certificate of registration otherwise than in accordance with the application; or

(c)to revoke, vary or suspend a certificate of registration.

(4) This paragraph also applies if, having been consulted under paragraph 2(2), the appropriate committee has not given a provisional opinion in the terms described in paragraph 5(2), and the licensing authority proposes—

(a)to determine the application for the certificate of registration in a way that differs from the appropriate committee's advice;

(b)to revoke, vary or suspend the authorisation against such advice; or

(c)on grounds not relating to safety or quality—

(i)to refuse to grant or renew the certificate,

(ii)to grant or renew the certificate otherwise than in accordance with the application, or

(iii)to revoke, vary or suspend the certificate.

[F1472(4A) This paragraph also applies if, having been consulted under paragraph 2(2A), the appropriate committee has not given a provisional opinion in the terms described in paragraph 5(2A) and the licensing authority proposes to decide, against that committee's advice, that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.]

(5) The licensing authority must notify the applicant for the grant or renewal or (as the case may be) the holder of the authorisation [F1473, licence], certificate or registration in writing of its proposal.

(6) The notification must state—

(a)the reasons for the proposal; and

(b)any advice of the appropriate committee and any reasons it has given for that advice.

Textual Amendments

Right to review or representations after paragraph 12 notificationU.K.

13.—(1) A person to whom a notification is given under paragraph 12 may—U.K.

(a)notify the licensing authority in writing that the person wishes the licensing authority to submit the proposal to review upon oral representations, or

(b)make representations in writing to the licensing authority with respect to the proposal.

(2) The person must give the notification or make the representations within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

(3) A review in accordance with sub-paragraph (1)(a) must be conducted in accordance with Schedule 5.

(4) If the person makes written representations in accordance with sub-paragraph (1)(b) the licensing authority must take them into account before determining the matter.

[F1474PART 1AU.K.Paediatric Decisions

Textual Amendments

Application of this PartU.K.

13A.  This Part applies to a proposed decision by the licensing authority—

(a)to refuse to agree a paediatric investigation plan (including a waiver or deferral proposed to be included in that plan), or to agree such a plan otherwise than in accordance with the request for agreement;

(b)to refuse to agree a modification to a paediatric investigation plan (including a waiver or deferral which is, or is proposed to be, included in that plan), or to agree such a modification otherwise than in accordance with the request for the modification;

(c)to impose, revoke or refuse to grant a waiver of the obligation under regulation 50A(3) to provide to the licensing authority the results of all studies performed, and details of all information collected, in compliance with an agreed paediatric investigation plan; or

(d)to revoke a waiver which was agreed as part of an agreed paediatric investigation plan.

Opportunity to make representationsU.K.

13B.—(1) If the licensing authority proposes to make a decision to which this Part applies, the licensing authority must notify the person to whom the proposed decision would be addressed (“the applicant”).

(2) The applicant may, by notice in writing to the licensing authority, request the opportunity to make written or oral representations to the appropriate committee.

(3) The applicant must make the request before the end of the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

(4) The licensing authority must inform the appropriate committee of the applicant's request.

Written representationsU.K.

13C.—(1) If the applicant requests the opportunity to make written representations, the applicant must provide the appropriate committee with those representations and any documents on which the applicant wishes to rely in support of them—

(a)before the end of the period of 28 days beginning with the date of the request; or

(b)before the end of such shorter period as the licensing authority may specify in the notification under paragraph 13B.

(2) The appropriate committee may at the request of the applicant extend the period mentioned in sub-paragraph (1) up to a maximum of 56 days beginning with the date of the request under paragraph 13B.

(3) The applicant may submit additional representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) The appropriate committee must—

(a)take the representations made under this paragraph into account; and

(b)report its findings and advice to the licensing authority together with the reasons for that advice.

Oral representationsU.K.

13D.—(1) If the applicant requests the opportunity to make oral representations, the applicant must provide the appropriate committee with a written summary of those representations and any documents on which the applicant wishes to rely in support of them—

(a)before the end of the period of 28 days beginning with the date of the request; or

(b)before the end of such shorter period as the licensing authority may specify in the notification under paragraph 13B.

(2) The appropriate committee may, at the request of the applicant, extend the period mentioned in sub-paragraph (1) up to a maximum of 56 days beginning with the date of the request under paragraph 13B.

(3) The applicant may submit additional representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) After receiving the summary and any other documents provided under this paragraph, the appropriate committee must arrange for the applicant to make oral representations at a hearing before the committee.

(5) The appropriate committee must—

(a)take the representations made under this paragraph into account; and

(b)report its findings and advice to the licensing authority together with the reasons for that advice.

Other decisions of the appropriate committeeU.K.

13E.—(1) This paragraph applies if the applicant—

(a)requests the opportunity to make written representations, but fails to make those representations within the period for doing so; or

(b)requests the opportunity to make oral representations, but—

(i)fails to provide a summary of those representations or the documents in support of them within the period for doing so, or

(ii)fails to make oral representations at a hearing before the appropriate committee.

(2) The appropriate committee must notify the licensing authority of that fact.

Decision of licensing authorityU.K.

13F.—(1) The licensing authority must decide whether to proceed with its proposed decision—

(a)if the applicant requested the opportunity to make written or oral representations, after receiving the appropriate committee's report under paragraph 13C or 13D or notification under paragraph 13E; or

(b)if the applicant did not request the opportunity to make written or oral representations, after the expiry of the period of time for notifying a request for that opportunity.

(2) If the appropriate committee gives a report under paragraph 13C or 13D, the licensing authority must take that into account in making its decision.

(3) The licensing authority must notify the applicant of—

(a)its decision; and

(b)any advice given to it by the appropriate committee and the reasons for that advice.

Right to review after paragraph 13F notificationU.K.

13G.—(1) This paragraph applies if the licensing authority notifies the applicant of its decision under paragraph 13F.

(2) The applicant may notify the licensing authority in writing that the applicant wishes the licensing authority to submit the decision to review upon oral representations.

(3) The applicant must give the notification before the end of the period of 28 days beginning with the day on which the notification is given to the applicant under paragraph 13F or such longer period as the licensing authority may allow.

(4) The review must be conducted in accordance with Schedule 5.

(5) This paragraph does not apply if the applicant has not made any representations in accordance with paragraph 13C or 13D.]

PART 2U.K.Type II variation applications, complex variation applications and new excipient variation applications

Application of this PartU.K.

14.  This Part applies—U.K.

(a)to an application (a “Type II variation application”) to vary a UK marketing authorisation if the variation is a major variation of Type II within the meaning of Article 2(3) of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products M81 [F1475or paragraph 1 of Schedule 10A]; and

(b)to an application to vary a traditional herbal registration that is—

(i)a complex variation application, or

(ii)a new excipient variation application.

Textual Amendments

Marginal Citations

M81OJ No L 334, 12.12.2008, p.7.

15.—(1) In paragraph 14(b)(i) “complex variation application” means an application by the holder of the registration to vary it so that one or more of the following changes can be made to the product to which it relates—U.K.

(a)a change in the product's active ingredients by the addition of an active ingredient from a new source;

(b)a change in the product's excipients by the addition of a TSE risk excipient from a new source; or

(c)a change by the addition of a vitamin or mineral from a new source, where no European Pharmacopoeia certificate of suitability for the vitamin or mineral is submitted with the application.

(2) For the purpose of sub-paragraph (1), an ingredient, vitamin or mineral is “from a new source” if its manufacturer as named in the application has not been named as its manufacturer in a [F1476UK] marketing authorisation or traditional herbal registration granted for a medicinal product including the ingredient, vitamin or mineral.

(3) For the purpose of sub-paragraph (1), an excipient is a “TSE risk excipient from a new source” if—

(a)it has been manufactured from raw materials of ruminant origin or such raw materials have been used in its manufacture; and

(b)its manufacturer as named in the application has not been named as its manufacturer in a [F1477UK] marketing authorisation or traditional herbal registration granted for a medicinal product that includes the excipient.

Textual Amendments

16.—(1) In paragraph 14(b)(ii) “new excipient variation application” means an application (other than a complex variation application) by the holder of the registration to vary it so that the formulation of the medicinal product to which it relates can be changed by the addition of a new excipient.U.K.

(2) For the purpose of sub-paragraph (1) “new excipient” means, subject to paragraphs (3) and (4), an ingredient of a medicinal product that is not an active ingredient and that has not been included in a medicinal product—

(a)intended to be administered by the same route as the product to which the application relates; and

(b)for which a [F1478UK] marketing authorisation (other than a product licence of right) or traditional herbal registration has been granted.

(3) In the application of sub-paragraph (1) to a medicinal product intended to be administered orally, the reference to a new excipient does not include any ingredient specified in an enactment as an approved ingredient or additive in food or in a food product.

(4) In the application of sub-paragraph (1) to a medicinal product intended for external use only, the reference to a new excipient does not include any ingredient specified in an enactment as an approved ingredient or additive in a cosmetic product.

(5) In this paragraph “enactment” includes an enactment comprised in subordinate legislation F1479....

Textual Amendments

[F148017.  In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.]U.K.

Textual Amendments

Opportunity to make representationsU.K.

18.—(1) This paragraph applies if the licensing authority notifies the applicant for a variation to which this Part applies that it has decided, on grounds relating to safety, quality or efficacy—U.K.

(a)to refuse to grant the application, or

(b)to grant it otherwise than in accordance with the application.

(2) The applicant may by notice in writing to the licensing authority request the opportunity to make written or oral representations to the appropriate committee.

(3) The applicant must make the request within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

(4) The licensing authority must inform the appropriate committee of the applicant or holder's request.

Written representationsU.K.

19.—(1) If the applicant requests the opportunity to make written representations, the applicant must provide the appropriate committee with those representations and any documents on which the applicant wishes to rely in support of them—U.K.

(a)before the end of the period of six months beginning with the date of the request; or

(b)before the end of such shorter period as the licensing authority may specify in the notification under paragraph 18.

(2) The appropriate committee may, at the request of the applicant, extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 18.

(3) The applicant may submit additional representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) The appropriate committee must—

(a)take the representations made under this paragraph into account; and

(b)report its findings and advice to the licensing authority together with the reasons for that advice.

Oral representationsU.K.

20.—(1) If the applicant requests the opportunity to make oral representations, the applicant must provide the appropriate committee with a written summary of those representations and any documents on which the applicant wishes to rely in support of them—U.K.

(a)before the end of the period of six months beginning with the date of the request; or

(b)before the end of such shorter period as the licensing authority may specify in the notification under paragraph 18.

(2) The appropriate committee may, at the request of the applicant, extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 18.

(3) The applicant may submit additional written representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) After receiving the summary and any other documents provided under this paragraph, the appropriate committee must arrange for the applicant to make oral representations at a hearing before the committee.

(5) The appropriate committee must—

(a)take the representations made under this paragraph into account; and

(b)report its findings and advice to the licensing authority together with the reasons for that advice.

Other decisions of the appropriate committeeU.K.

21.—(1) This paragraph applies if the applicant—U.K.

(a)requests the opportunity to make written representations, but fails to make those written representations within the period for doing so; or

(b)requests the opportunity to make oral representations, but—

(i)fails to provide a summary of those representations or the documents in support of them within the period for doing so, or

(ii)fails to make oral representations at a hearing before the appropriate committee.

(2) The appropriate committee must notify the licensing authority of that fact.

Decision of licensing authority following reportU.K.

22.—(1) After receiving the appropriate committee's report under paragraph 19 or 20 or notification under paragraph 21 the licensing authority must confirm or alter its decision.U.K.

(2) If the appropriate committee gives a report under paragraph 19 or 20, the licensing authority must take that into account in making its decision.

(3) The licensing authority must notify the applicant or holder of—

(a)its decision; and

(b)any advice given to it by the appropriate committee and the reasons for that advice.

Right to review after paragraph 22 notificationU.K.

23.—(1) This paragraph applies if the licensing authority notifies the applicant of its decision under paragraph 22—U.K.

(a)to refuse the application; or

(b)to grant it otherwise than in accordance with the application.

(2) The applicant may notify the licensing authority in writing that the person wishes the licensing authority to submit the decision to review upon oral representations.

(3) The applicant must give the notification within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

(4) The review must be conducted in accordance with Schedule 5.

(5) This paragraph does not apply if the person has not made any representations in accordance with paragraph 19 or 20.

PART 3U.K.Referral to the [F1481appropriate committee for traditional herbal registrations]

Textual Amendments

Application of this PartU.K.

24.—(1) This Part applies if the licensing authority proposes to refer an application for a traditional herbal registration to the [F1482appropriate committee in accordance with regulation 130A(1)].U.K.

[F1483(2) In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.]

Textual Amendments

Opportunity to make representationsU.K.

25.—(1) The licensing authority must notify the applicant of the authority's proposal.U.K.

(2) The applicant may by notice in writing to the licensing authority request the opportunity to make written or oral representations to the appropriate committee.

(3) The applicant must make the request within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

(4) The licensing authority must inform the appropriate committee of the applicant or holder's request.

Written representationsU.K.

26.—(1) If the applicant requests the opportunity to make written representations, the applicant must provide the appropriate committee with those representations and any documents on which the applicant wishes to rely in support of them—U.K.

(a)before the end of the period of six months beginning with the date of the request; or

(b)before the end of such shorter period as the licensing authority may specify in the notification under paragraph 25.

(2) The appropriate committee may, at the request of the applicant, extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 25.

(3) The applicant may submit additional representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) The appropriate committee must—

(a)take the representations made under this paragraph into account; and

(b)report its findings and advice to the licensing authority together with the reasons for that advice.

Oral representationsU.K.

27.—(1) If the applicant requests the opportunity to make oral representations, the applicant must provide the appropriate committee with a written summary of those representations and any documents on which the applicant wishes to rely in support of them—U.K.

(a)before the end of the period of six months beginning with the date of the request; or

(b)before the end of such shorter period as the licensing authority may specify in the notification under paragraph 25.

(2) The appropriate committee may, at the request of the applicant, extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 24.

(3) The applicant may submit additional written representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) After receiving the summary and any other documents provided under this paragraph, the appropriate committee must arrange for the applicant to make oral representations at a hearing before the appropriate committee.

(5) The appropriate committee must—

(a)take the representations made under this paragraph into account; and

(b)report its findings and advice to the licensing authority together with the reasons for that advice.

Other decisions of the appropriate committeeU.K.

28.—(1) This paragraph applies if the applicant—U.K.

(a)requests the opportunity to make written representations, but fails to make those written representations within the period for doing so; or

(b)requests the opportunity to make oral representations, but—

(i)fails to provide a summary of those representations or the documents in support of them within the period for doing so, or

(ii)fails to make oral representations at a hearing before the appropriate committee.

(2) The appropriate committee must notify the licensing authority of that fact.

Decision of licensing authority following reportU.K.

29.—(1) After receiving the appropriate committee's report under paragraph 26 or 27 or notification under paragraph 28 the licensing authority must decide whether to [F1484grant or refuse the application].U.K.

(2) If the appropriate committee gives a report under paragraph 26 or 27, the licensing authority must take that into account in making its decision.

(3) The licensing authority must notify the applicant or holder of—

(a)its decision; and

(b)any advice given to it by the appropriate committee and the reasons for that advice.

Textual Amendments

Right to review after paragraph 29 notificationU.K.

30.—(1) This paragraph applies if the licensing authority notifies the applicant of its decision under paragraph 29 to refer the applicant to the Committee on Herbal Medicinal Products as proposed.U.K.

(2) The applicant may notify the licensing authority in writing that the person wishes the licensing authority to submit the decision to review upon oral representations.

(3) The applicant must give the notification within the period of 28 days beginning with the day on which the licensing authority's notification is given or such longer period as the licensing authority may allow.

(4) The review must be conducted in accordance with Schedule 5.

(5) This paragraph does not apply if the person has not made any representations in accordance with paragraph 26 or 27.

PART 4U.K.Exceptions to Schedule

F148531.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

Textual Amendments

32.  This Schedule does not apply to an application for the grant of a UK marketing authorisation, certificate of registration or traditional herbal registration if the application has been submitted to the licensing authority in accordance with Article 28 of the 2001 Directive.U.K.

33.  This Schedule ceases to apply if at any time the matter in question is referred to the Committee for Medicinal Products for Human Use or the Committee for Herbal Medicinal Products under Article 30 or 31 of the 2001 Directive for the application of the procedure laid down in Articles 32 to 34 of that Directive.U.K.

F148634.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

Textual Amendments

F148735.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

Textual Amendments

36.  This Schedule does not apply if the application or proposal relates to the renewal, revocation, suspension or variation of a UK marketing authorisation that—U.K.

(a)was granted in accordance with the provisions of Chapter 4 of Title III to the 2001 Directive (mutual recognition procedure and decentralised procedure);

(b)was granted before 1st January 1995 by member States in accordance with Article 4 of Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology M82; or

(c)was subject to the procedure laid down in Articles 32 to 34 of the 2001 Directive following a referral under Article 30 or 31 of that Directive, unless the procedure was limited to certain specific parts of the authorisation.

Marginal Citations

M82OJ No L 15, 17.1.1987. p.38.

F148837.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

Textual Amendments

F148938.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

Textual Amendments

39.  This Schedule does not apply if—U.K.

(a)the licensing authority refuse to grant an application for a traditional herbal registration;

(b)the application was referred to the Committee for Herbal Medicinal Products in accordance with Article 16c(4) of the 2001 Directive; and

(c)the Committee for Herbal Medicinal Products did not support the grant of the application.

Regulation 128(1)

SCHEDULE 12U.K.Material to accompany an application for a traditional herbal registration

PART 1U.K.General requirements

1.  The name or corporate name and permanent address of the applicant and (where applicable) of the manufacturer of the medicinal product.U.K.

2.  The name of the medicinal product. This may be—U.K.

(a)an invented name that is not liable to confusion with the product's common name; or

(b)a common or scientific name accompanied by a trademark or by the name of the person who is to be the holder of the traditional herbal registration.

3.  Qualitative and quantitative particulars of the constituents of the medicinal product, including—U.K.

(a)where there is an international non-proprietary name recommended by the World Health Organisation for a constituent, a reference to that name; or

(b)otherwise, a reference to the relevant chemical or botanical name.

4.  An evaluation of the potential environmental risks posed by the medicinal product, including an assessment of its environmental impact and a description of the proposed arrangements for limiting that impact on a case by case basis.U.K.

5.  A description of the methods of manufacturing the medicinal product.U.K.

6.  The therapeutic indications and contra-indications for the medicinal product and the adverse reactions associated with it.U.K.

7.  The posology and pharmaceutical form of the medicinal product, its method and route of administration and its expected shelf life.U.K.

8.  The reasons for any precautionary and safety measures to be taken for—U.K.

(a)the storage of the medicinal product;

(b)the administration of the medicinal product to patients; and

(c)the disposal of the medicinal product and any waste products,

with an indication of the potential risks presented by the medicinal product for the environment.

9.  A description of the control methods employed by the manufacturer.U.K.

10.  Results of pre-clinical (toxicological and pharmacological) tests in relation to the medicinal product and its constituent active substances.U.K.

11.  A detailed summary of those results prepared and signed by an expert with appropriate technical or professional qualifications, which must be set out in a brief curriculum vitae.U.K.

12.  A summary of the product characteristics for the medicinal product in accordance with Part 2 of this Schedule.U.K.

13.  A mock-up, in accordance with Part 13 (packaging and leaflets) of—U.K.

(a)the outer packaging of the medicinal product;

(b)the immediate packaging of the medicinal product; and

(c)the package leaflet for the medicinal product.

14.  A document showing that the manufacturer of the medicinal product is authorised to produce medicinal products in the manufacturer's own country.U.K.

15.  Where the medicinal product consists of a combination of one or more herbal substances and one or more herbal preparations, or the medicinal product contains one or more vitamins or minerals—U.K.

(a)data on the traditional use of the medicinal product as a whole; and

(b)if any of the medicinal product's individual active ingredients are not sufficiently known, data on the traditional use of those active ingredients.

This covers (in particular)—

(c)evidence that the product is not harmful in the specified conditions of use; and

(d)evidence as to the pharmacological effects or efficacy of the product on the basis of long-standing use and experience.

16.  Details of any authorisation or registration obtained by the applicant in [F1490a country other than the United Kingdom] allowing the medicinal product to be placed on the market.U.K.

Textual Amendments

17.  Details of any decision in [F1491a country other than the United Kingdom] to refuse to grant an authorisation or registration allowing the medicinal product to be placed on the market, with the reasons for any such decision.U.K.

Textual Amendments

18.  Bibliographical or expert evidence of the traditional use of the medicinal product or a product corresponding to the medicinal product.U.K.

For this purpose a product (“A”) corresponds to a medicinal product (“B”) if—

(a)product A has the same active ingredients as product B (regardless of the excipients used in either product);

(b)product A's intended purpose is the same as or similar to product B's intended purpose;

(c)product A has a strength and dosage equivalent to that of product B; and

(d)product A's route of administration is the same as or similar to product B's route of administration.

19.  A bibliographic review of safety data.U.K.

20.  An expert report on safety.U.K.

PART 2U.K.Summary of the product characteristics

The summary of the product characteristics must contain the following information in the following order—

21.  For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004 [F1492or regulation 202A, as the case may be], the [F1493symbol and] statement “[F1494▼] This medicinal product is subject to additional monitoring”.U.K.

Textual Amendments

22.  The name of the medicinal product followed by its strength and pharmaceutical form.U.K.

23.  The qualitative and quantitative composition, using the usual common name or chemical description, of the medicinal product in terms of—U.K.

(a)the active substances; and

(b)those excipients of which knowledge is essential for proper administration of the medicinal product.

24.  The pharmaceutical form of the medicinal product.U.K.

25.  The pharmacological properties of the medicinal product, covering—U.K.

(a)pharmacodynamic properties;

(b)pharmacokinetic properties; and

(c)pre-clinical safety data.

26.  Pharmaceutical particulars of the medicinal product, covering—U.K.

(a)a list of excipients;

(b)major incompatibilities;

(c)shelf life after reconstitution of the medicinal product or when the immediate packaging is opened for the first time (as appropriate);

(d)special precautions for storage;

(e)nature and contents of the container; and

(f)special precautions for disposal of the used medicinal product or waste materials derived from the medicinal product (as appropriate).

27.  The holder of the traditional herbal registration.U.K.

28.  The number of the traditional herbal registration.U.K.

29.  The date of the first traditional herbal registration or, where the traditional herbal registration has been renewed, the date of the last renewal.U.K.

30.  The date of any revisions of the text of the summary of the product characteristics.U.K.

Regulation 205A

[F1495SCHEDULE 12AU.K.Further provision as to the performance of pharmacovigilance activities

Textual Amendments

PART 1U.K.Pharmacovigilance system master file

Structure of the pharmacovigilance system master fileU.K.

1.—(1) The information in the pharmacovigilance system master file must be accurate and reflect the pharmacovigilance system in place.

(2) The holder may, where appropriate, use separate pharmacovigilance systems for different categories of medicinal products and if it does so, each such system must be described in a separate pharmacovigilance system master file.

(3) All medicinal products for which the holder obtained a UKMA(GB) [F1496or a UKMA(UK)(Category 1)] in accordance with these Regulations must be covered by a pharmacovigilance system master file.

Textual Amendments

Content of the pharmacovigilance system master fileU.K.

2.  The pharmacovigilance system master file must, as a minimum, contain—

(a)the following information relating to the qualified person responsible for pharmacovigilance—

(i)a description of the responsibilities demonstrating that the qualified person for pharmacovigilance has sufficient authority over the pharmacovigilance system in order to promote, maintain and improve compliance with pharmacovigilance tasks and responsibilities,

(ii)a summary curriculum vitae of the qualified person responsible for pharmacovigilance,

(iii)contact details of the qualified person for pharmacovigilance,

(iv)details of back-up arrangements to apply in the absence of the qualified person responsible for pharmacovigilance, and

(v)responsibilities and contact details of the nominated person (where a person is nominated under regulation 182(2A));

(b)a description of the organisational structure of the holder, including the list of each site where one or more of the following pharmacovigilance activities are undertaken—

(i)individual case safety report collection and evaluation,

(ii)safety database case entry,

(iii)periodic safety update report production,

(iv)signal detection and analysis,

(v)risk management plan management,

(vi)pre and post-authorisation study management, and

(vii)management of safety variations to the terms of a UK marketing authorisation;

(c)a description of the location of, functionality of and operational responsibility for computerised systems and databases used to receive, collate, record and report safety information, and an assessment of their fitness for purpose;

(d)a description of data handling and recording and of the process used for each of the following pharmacovigilance activities—

(i)the continuous monitoring of the risk-benefit balance of each medicinal product, the result of that monitoring and the decision-making process for taking appropriate measures,

(ii)operation of each risk management system and of the monitoring of the outcome of risk minimisation measures,

(iii)collection, assessment and reporting of individual case safety reports,

(iv)drafting and submission of periodic safety update reports, and

(v)procedures for communicating safety concerns and safety variations to the summary of product characteristics and package leaflet to healthcare professionals and the general public;

(e)a description of the quality system for the performance of pharmacovigilance activities, including—

(i)a description of—

(aa)the organisational structure for the performance of pharmacovigilance activities,

(bb)a summary description of the training concept, including a reference to the location of training files and qualifications records, and

(cc)instructions on critical processes,

(ii)a description of the record management system referred to in paragraph 12, including the location of the documents used for pharmacovigilance activities,

(iii)a description of the system for monitoring the performance of the pharmacovigilance system; and

(f)where applicable, a description of the activities or services subcontracted by the holder.

Content of the Annex to the pharmacovigilance system master fileU.K.

3.  The pharmacovigilance system master file must have an Annex containing the following documents—

(a)a list of medicinal products covered by the pharmacovigilance system master file, including the name of each medicinal product, the international non-proprietary name (INN) of each active substance and the countries other than the United Kingdom in which the products covered are authorised to be marketed;

(b)a list of written policies and procedures for the purpose of complying with Part 11 of these Regulations;

(c)the list of any sub-contracts falling within paragraph 6(1);

(d)a list of the tasks that have been delegated by the qualified person for pharmacovigilance;

(e)a list of all scheduled and completed audits;

(f)where applicable, a list of the performance indicators that support the quality system for pharmacovigilance specified in paragraph 2(e);

(g)where applicable, a list of other pharmacovigilance system master files held by the same holder; and

(h)a logbook containing a record of any alteration of the content of the pharmacovigilance system master file made within the preceding 5 year period, except any alteration of the content that is specified in of paragraph 2(a)(ii) to (iv) or this paragraph.

Maintenance of the pharmacovigilance system master fileU.K.

4.—(1) The holder must keep the pharmacovigilance system master file up to date and, where necessary, revise it to take account of experience gained, and of technical and scientific progress.

(2) The pharmacovigilance system master file and its Annex must be subject to version control and, in particular, must indicate the date when it was last updated by the holder.

(3) Any deviations from the pharmacovigilance procedures, their impact and their management must be documented in the pharmacovigilance system master file until resolved.

Form of the documents contained in the pharmacovigilance system master fileU.K.

5.—(1) The pharmacovigilance system master file documents must be complete and legible.

(2) Subject to sub-paragraph (1), in the pharmacovigilance system master file—

(a)where appropriate, information may be provided in the form of charts or flow diagrams;

(b)all documents must be indexed and archived so as to ensure their accurate and ready retrieval throughout the period for record-keeping; and

(c)the particulars and documents may be presented in modules in accordance with the system delineated in detail in the guidance on good pharmacovigilance practices which applies by virtue of regulation 205B.

(3) The pharmacovigilance system master file may be stored in electronic form provided that the media used for storage remain readable over time, and a clearly arranged printed copy can be made available for audits and inspections.

SubcontractingU.K.

6.—(1) The holder may subcontract certain activities of the pharmacovigilance system to third parties, but if it does so it must nevertheless retain full responsibility for the completeness and accuracy of the pharmacovigilance system master file.

(2) The holder must draw up a list of the existing subcontracts between it and the third parties referred to in sub-paragraph (1), specifying each product and each country concerned.

Availability and location of the pharmacovigilance system master fileU.K.

7.—(2) The holder must ensure that the qualified person and nominated person (where a person is nominated under regulation 182(2A)) for pharmacovigilance have permanent access to the pharmacovigilance system master file.

(3) For the purposes of regulation 182(2)(b), the licensing authority may limit its request to specific parts or modules of the pharmacovigilance system master file and the holder is to bear the costs of submitting the copy of the pharmacovigilance system master file.

(4) The licensing authority may request the holder to submit a copy of the logbook referred to in paragraph 3(h) at regular intervals.

PART 2U.K.Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority and holders

Quality systemU.K.

8.—(1) Any holder, and the licensing authority, must establish and use a quality system that is adequate and effective for the performance of their pharmacovigilance activities.

(2) The quality system must cover organisational structure, responsibilities, procedures, processes and resources, appropriate resource management, compliance management and record management.

(3) The quality system must be based on all of the following activities—

(a)quality planning: establishing structures and planning integrated and consistent processes;

(b)quality adherence, namely carrying out tasks and responsibilities in accordance with quality requirements;

(c)quality control and assurance, namely monitoring and evaluating how effectively the structures and processes have been established and how effectively the processes are being carried out; and

(d)quality improvements, namely correcting and improving the structures and processes where necessary.

(4) All elements, requirements and provisions adopted for the quality system must be documented in a systematic and orderly manner in the form of written policies and procedures, such as quality plans, quality manuals and quality records.

(5) All persons involved in the procedures and processes of the quality systems established by the licensing authority for the performance of pharmacovigilance activities shall be responsible for the good functioning of those quality systems, and must ensure a systematic approach towards quality and towards the implementation and maintenance of the quality system.

Performance indicatorsU.K.

9.—(1) The holder and the licensing authority may use performance indicators to continuously monitor the good performance of pharmacovigilance activities.

(2) The licensing authority may publish a list of performance indicators.

PART 3U.K.Minimum requirements for the quality systems for the performance of pharmacovigilance activities by holders

Management of human resourcesU.K.

10.—(1) The holder must have sufficient competent and appropriately qualified and trained personnel available for the performance of pharmacovigilance activities.

(2) For the purposes of sub-paragraph (1), the holder must—

(a)ensure that the qualified person responsible for pharmacovigilance has acquired adequate theoretical and practical knowledge for the performance of pharmacovigilance activities; and

(b)where the qualified person has not completed basic medical training in accordance with Article 24 of Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications, ensure that the qualified person responsible for pharmacovigilance is assisted by a medically trained person, with such assistance being duly documented.

(3) The duties of the managerial and supervisory staff, including the qualified person responsible for pharmacovigilance, must be defined in job descriptions and their hierarchical relationships must be defined in an organisational chart.

(4) The holder must ensure that the qualified person responsible for pharmacovigilance has sufficient authority to influence the performance of the quality system and the pharmacovigilance activities of the holder.

(5) All personnel involved in the performance of pharmacovigilance activities must receive initial and continued training in relation to their role and responsibilities, and the holder must keep training plans and records for documenting, maintaining and developing the competences of personnel and make them available for audit or inspection.

(6) The holder must provide appropriate instructions on the processes to be used in case of urgency, including business continuity.

Compliance managementU.K.

11.—(1) Specific quality system procedures and processes must be in place in order to ensure the following—

(a)the continuous monitoring of pharmacovigilance data, the examination of options for risk minimisation and prevention and that appropriate measures are taken by the holder;

(b)the scientific evaluation by the holder of all information on the risks of medicinal products, as referred to in regulation 182(4)(a);

(c)the submission of accurate and verifiable data on serious and non-serious adverse reactions to the licensing authority within the time limits provided for in regulation 188(1)(a) or (b);

(d)the quality, integrity and completeness of the information submitted on the risks of medicinal products, including processes to avoid duplicate submissions;

(e)effective communication by the holder with the licensing authority, including communication on—

(i)new risks or changed risks,

(ii)the pharmacovigilance system master file,

(iii)risk management systems,

(iv)risk minimisation measures,

(v)periodic safety update reports,

(vi)corrective and preventive actions, and

(vii)post-authorisation studies;

(f)the update of product information by the holder in the light of scientific knowledge, including the assessments and recommendations made public via the UK web-portal, and on the basis of a continuous monitoring by the holder of information published on that web-portal; and

(g)appropriate communication by the holder of relevant safety information to healthcare professionals and patients.

(2) Where a holder has subcontracted some of its pharmacovigilance tasks, it must retain responsibility for ensuring that an effective quality system is applied in relation to those tasks.

Record management and data retentionU.K.

12.—(1) A holder must record all pharmacovigilance information and ensure that it is handled and stored so as to allow for accurate reporting, interpretation and verification of that information.

(2) A holder must put in place a record management system for all documents used for pharmacovigilance activities that ensures—

(a)the retrievability of those documents; and

(b)the traceability of the measures taken to investigate safety concerns, of the timelines for those investigations and of decisions on safety concerns, including their date and the decision-making process.

(3) A holder must establish mechanisms enabling the traceability and follow-up of adverse reaction reports.

(4) A holder must arrange for the elements referred to in sub-paragraph (2) to be kept for at least five years, beginning with the day after the system as described in the pharmacovigilance system master file has been formally terminated by the holder.

(5) Pharmacovigilance data and documents relating to individual authorised medicinal products must be retained as long as the product is authorised and for at least 10 years, beginning with the date on which the UKMA(GB) [F1497or the UKMA(UK)(Category 1), as the case may be,] ceased to exist.

Textual Amendments

AuditU.K.

13.—(1) Risk-based audits of the quality system must be performed at regular intervals to ensure that the quality system complies with the quality system requirements set out in paragraphs 8, 10, 11 and 12, and to determine its effectiveness.

(2) The audits referred to in sub-paragraph (1) must be conducted by individuals who have no direct involvement in or responsibility for the matters or processes being audited.

(3) Following a risk-based audit—

(a)any corrective action, including a follow-up audit of deficiencies, must be taken where necessary;

(b)a report on the results of the audit must be drawn up for each audit and follow-up audit;

(c)the audit report must be sent to the management responsible for the matters audited; and

(d)the dates and results of audits and follow-up audits must be documented in accordance with regulation 184(1)(b).

PART 4U.K.Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority

Management of human resourcesU.K.

14.—(1) The licensing authority must have sufficient competent and appropriately qualified and trained personnel available for the performance of pharmacovigilance activities: the organisational structures and the distribution of tasks and responsibilities must be clear and, to the extent necessary, accessible.

(2) Named contact points in the licensing authority for pharmacovigilance activities must be established.

(3) The licensing authority must ensure that—

(a)all of its personnel involved in the performance of pharmacovigilance activities receive initial and continued training;

(b)it keeps training plans and records for documenting, maintaining and developing the competences of personnel; and

(c)such plans and records are available for audit.

(4) The licensing authority must ensure that it provides to its personnel performing pharmacovigilance activities appropriate instructions on the processes to be used in case of urgency, including business continuity.

Compliance managementU.K.

15.  The licensing authority must establish specific procedure