The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 3 U.K. Amendment of Part 3 (manufacture and distribution of medicinal products and active substances)

New regulation B17 and C17 (good manufacturing practice and good distribution practice) U.K.

13.  After regulation A17 M1 insert—

“Chapter 1A U.K. Good manufacturing practice and good distribution practice

Regulations on good manufacturing practice

B17.— (1) The [F1 Secretary of State] may by regulations [F2 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 [F3 or EU marketing authorisation];

(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 [F4 in Great Britain] on and after [F5 IP completion day] as they had effect immediately before [F5 IP completion day], but subject to the modifications specified in Schedule 2A.

(4) The [F6 Secretary of State] may by regulations [F7 in respect of Great Britain] amend or revoke Schedule 2A.

Guidelines on good manufacturing practice and good distribution practice

C17.— (1) The licensing authority may publish [F8 in relation to the manufacture or assembly of a medicinal product in, or import to, Great Britain]—

(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 [F9 IP completion day] M2 , continue to apply on and after [F9 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

F1 Words in reg. 13 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 8(a)(i)(aa)

F2 Words in reg. 13 inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 8(a)(i)(bb)

F3 Words in reg. 13 inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 8(a)(ii)

F4 Words in reg. 13 inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 8(a)(iii)(aa)

F5 Words in reg. 13 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 8(a)(iii)(bb)

F6 Words in reg. 13 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 8(a)(iv)(aa)

F7 Words in reg. 13 inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 8(a)(iv)(bb)

F8 Words in reg. 13 inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 8(b)(i)

F9 Words in reg. 13 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 8(b)(ii)

Commencement Information

I1 Reg. 13 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M1 Regulation A17 was inserted by S.I. 2013/1855.

M2 The principles and guidelines are available at: https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012 and a hard copy may be obtained from the Medicines and Healthcare products Regulatory Agency at the address given in the Explanatory Note.

Amendment of regulation 17 (manufacturing of medicinal products) U.K.

14.—(1) Regulation 17 is amended as follows.

[F10 (2) For paragraph (1) substitute—

“(1) A person may not except in accordance with a licence (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).”.]

F11 (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F12 (4) In paragraph (4), after sub-paragraph (a) insert—

“(aa) a UK marketing authorisation; or”.]

[F13 (5) In paragraph (5) omit “from a state other than an EEA State”.]

[F14 (6) After paragraph (6) insert—

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

(a) special medicinal products, and

(b) medicinal products that have been released for sale, supply or distribution in an EEA State or the United Kingdom before IP completion day.

(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.”.]

Textual Amendments

F10 Reg. 14(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 9(a)

F11 Reg. 14(3) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 9(b)

F12 Reg. 14(4) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 9(c)

F13 Reg. 14(5) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 9(d)

F14 Reg. 14(6) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 9(e)

Commencement Information

I2 Reg. 14 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 18 (wholesale dealing in medicinal products) U.K.

15.—(1) Regulation 18 M3 is amended as follows.

(2) In paragraph (1)—

(a) in sub-paragraph (a), omit “or”;

(b) in sub-paragraph (b) for “distribution.” substitute “ distribution; or ”;

(c) insert at the end—

“(c) import a medicinal product [F15 into Great Britain] from an approved country for import F16 ....”.

[F17 (2A) After paragraph (2) insert—

“(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.”.]

[F18 (3) For paragraph (6) substitute—

“(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, or

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

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

[F19 (4) In paragraph (7) for “paragraph (6)” substitute “paragraph (6)(b)”.]

Textual Amendments

F15 Words in reg. 15(2)(c) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 10(a)(i)

F16 Words in reg. 15(2)(c) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 10(a)(ii)

F17 Reg. 15(2A) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 10(b)

F18 Reg. 15(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 10(c)

F19 Reg. 15(4) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 10(d)

Commencement Information

I3 Reg. 15 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M3 Regulation 18 was substituted by S.I. 2013/1855 and further amended by S.I. 2016/186.

Insertion of new regulation 18A (approved country for import) U.K.

16.  After regulation 18, insert—

“Approved country for import

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.”.

Commencement Information

I4 Reg. 16 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 19 (exemptions from requirement for wholesale dealer's licence) U.K.

17.—(1) Regulation 19 M4 is amended as follows.

[F20 (2) For paragraph (1)(a) substitute—

“(a) the holder of—

(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”) 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), an EU marketing authorisation 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”.]

(3) In paragraph (1)(b), after “or assembled the product” insert “ in the United Kingdom ”.

[F21 (4) At the end insert—

“(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

F20 Reg. 17(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 11(a)

F21 Reg. 17(4) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 11(b)

Commencement Information

I5 Reg. 17 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M4 Regulation 19 was amended by S.I. 2013/1855.

Amendment of Schedule 3 (applications for licences under Part 3) U.K.

18.—(1) Schedule 3 is amended as follows.

[F22 (2) For paragraph 1(2)(g) substitute—

“(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);”.]

[F23 (3) For paragraph 2(1) substitute—

“2.— (1) This paragraph applies to an application for a manufacturer’s licence relating to the import from—

(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.”.]

(4) In paragraph 3—

(a) in sub-paragraph (2)(d) at the end insert “ or the responsible person (import) ”.

(b) in sub-paragraph (3)(b)—

[F24 (i) for paragraph (i) substitute—

“(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,”,]

[F25 (ii) in paragraph (iv) before “an Article” insert “in the case of a product for sale or supply in Northern Ireland,”, and]

(iii) after paragraph (iii) insert—

“(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) in sub-paragraph (3)(d)—

(i) in paragraph (i) omit “or”,

(ii) in paragraph (ii) for “etc);” substitute “ etc), or ”,

(iii) at the end insert—

“(iii) to be distributed by means of export [F26 from Great Britain] to an approved country for import;”; and

(d) for sub-paragraph (4) substitute—

“(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

F22 Reg. 18(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 12(a)

F23 Reg. 18(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 12(b)

F24 Reg. 18(4)(b)(i) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 12(c)(i)

F25 Reg. 18(4)(b)(ii) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 12(c)(ii)

F26 Words in reg. 18(4)(c)(iii) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 12(d)

Commencement Information

I6 Reg. 18 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 23 (grant or refusal of licence) U.K.

19.  In regulation 23(1)(b), omit “and any European Union obligation”.

Commencement Information

I7 Reg. 19 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

[F27 Amendment of regulation 24 (standard provisions of licences) U.K.

19A.   In regulation 24, after paragraph (2) insert—

“(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

F27 Reg. 19A inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 13

Commencement Information

I8 Reg. 19A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of Schedule 4 (standard provisions of licences under Part 3) U.K.

20.—(1) Schedule 4 is amended as follows.

[F28 (2) For paragraph 13(b) substitute—

“(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,”.]

[F29 (2A) After paragraph 14 insert—

“14A.   A licence holder—

(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.”.]

[F30 (3) In the heading of Part 2, after “State Other Than an EEA State” insert “/ Country other than an Approved Country for Import”.]

[F31 (4) In paragraph 15, for “from a state other than an EEA State” substitute—

“from—

(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”.

(4A) In paragraphs 22(1) and 23, for “a state other than an EEA State” substitute “, 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”.

(4B) After paragraph 23, insert—

“23A.   A licence holder—

(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.”].

(5) In paragraph 25(m), for the words “referred to in Article 8(2) of Directive 2004/23/EC”, substitute—

“assigned by a tissue establishment pursuant to—

(a) paragraph 1 of Schedule 3A to the Human Fertilisation and Embryology Act 1990 M5 , 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 M6 , as regards other human tissues and cells.”.

[F32 (6) In paragraph 33, for “another EEA State” substitute “, 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”.]

[F33 (7) After paragraph 41 insert—

“41A.   A licence holder—

(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

F28 Reg. 20(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(a)

F29 Reg. 20(2A) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(b)

F30 Reg. 20(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(c)

F31 Reg. 20(4)-(4B) substituted for reg. 20(4) (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(d)

F32 Reg. 20(6) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(e)

F33 Reg. 20(7) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(f)

Commencement Information

I9 Reg. 20 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M5 1990 c. 37. Schedule 3A was inserted by the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007/1522, regulation 30.

M6 S.I. 2007/1523.

Amendment of regulation 26 (general power to suspend, revoke or vary licences) U.K.

[F34 21.   For regulation 26(5)(a) substitute—

“(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”), 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) or a THR(UK), an EU marketing authorisation or an Article 126a authorisation (an “authorisation”),

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

Textual Amendments

F34 Reg. 21 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 15

Commencement Information

I10 Reg. 21 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of Schedule 5 (review upon oral representations) U.K.

22.—(1) Schedule 5 M7 is amended as follows.

(2) In paragraph 1(2)(e), 3(11)(b) and 5(2)(d) after—

(a) “UK marketing authorisation,” in each place it appears, insert “ parallel import licence, ”; and

(b) “an authorisation,” or “the authorisation,” in each place it appears, insert “ licence, ”.

(3) In paragraph 3 omit sub-paragraph (11)(b)(iii).

(4) In paragraph 5 omit sub-paragraph (2)(c).

Commencement Information

I11 Reg. 22 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M7 Schedule 5 was amended by S.I. 2013/1855.

Amendment of regulation 29 (variation of licence on the application of the holder) U.K.

23.  In regulation 29(5)—

(a) in sub-paragraph (b) omit “or”;

(b) in sub-paragraph (c) for “granted.” substitute “ granted; or ”; and

(c) at the end insert—

“(d) the responsible person (import) under regulation 45AA.”.

Commencement Information

I12 Reg. 23 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 31 (certification of manufacturer's licence) U.K.

24.—(1) Regulation 31 is amended as follows.

(2) In paragraph (1)(c), for “an EEA State” substitute “ the United Kingdom ”.

[F35 (3) In paragraphs (3)(b), (5)(a) and (5)(b) for “marketing authorisation” substitute “UK marketing authorisation, EU marketing authorisation, Article 126a authorisation”.]

Textual Amendments

F35 Reg. 24(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 16

Commencement Information

I13 Reg. 24 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 33 (offence concerning data for advanced therapy medicinal products) U.K.

25.—(1) Regulation 33 is amended as follows.

(2) In paragraph (1)(a)—

(a) for “Article 15(1) of Regulation 1394/2007” substitute “ paragraph 8 of Schedule 6 ”; and

(b) for “Article 15(4) of that Regulation” substitute “ paragraph 9 of that Schedule ”.

(3) In paragraph (1)(b), for “Article 15(1)” substitute “ paragraph 8 ”.

(4) In paragraph (2) for “Article 15(4)” substitute “ paragraph 9 ”.

Commencement Information

I14 Reg. 25 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of Schedule 6 (manufacturer's and wholesale dealer's licences for exempt advanced therapy medicinal products) U.K.

26.—(1) Schedule 6 is amended as follows.

(2) In paragraph 3, for “Directive 2004/23/EC”, substitute—

“requirements imposed pursuant to—

(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.”.

(3) In paragraph 4, for the words “laid down in” to the end, substitute—

“imposed pursuant to—

(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.”.

(4) In paragraph 5, for the words from “Commission” to the end substitute “ the Blood Quality and Safety Regulations 2005 M8 ”.

(5) In paragraph 11, for the words from “laid down in” to the end, substitute—

“imposed 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 M9 ;

(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;”.

Commencement Information

I15 Reg. 26 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M8 S.I. 2005/50. It was amended by S.I. 2005/1098 and 2898, 2006/2013, 2007/604, 2008/525 and 941, 2009/372 and 3307, 2010/554, 2016/604, 2017/1320 and 2018/231.

M9 Sections 33A to 33D were inserted by the Human Fertilisation and Embryology Act 2008, c. 22.

Amendment of regulation 36 (conditions for manufacturer's licence) U.K.

27.  In regulation 36 [F36 —

(a) in paragraph (4)—.

(i) for “The requirements” substitute “Where a manufacturer’s licence relates to the manufacture or assembly of a medicinal product in, or import of a medicinal product into, Northern Ireland, the requirements”;

(ii) for “provisions of a manufacturer’s” substitute “provisions of that”;

(b) in paragraph (6), after “by way of wholesale dealing” insert “in Northern Ireland”.]

Textual Amendments

F36 Reg. 27(a)(b) substituted for words (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 17

Commencement Information

I16 Reg. 27 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 37 (manufacturing and assembly) U.K.

28.—(1) Regulation 37 M10 is amended as follows.

[F37 (1A) In paragraph (2), after “Good Manufacturing Practice Directive” insert “which apply under or by virtue of regulation B17”.]

[F38 (2) For paragraph (4)(b) substitute—

“(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”.]

[F39 (3) In paragraph (5)(b), after “as described” insert “in the case of a product for sale or supply in Great Britain, in the guidelines which apply under or by virtue of regulation C17 and, in the case of a product for sale or supply in Northern Ireland,]

[F40 (4) For paragraph (6)(b) substitute—

“(b) in the case of a product for sale or supply—

(i) in Great Britain, 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.”.]

(5) In paragraph (9)(a), from “Commission” to the end substitute “ the Blood Quality and Safety Regulations 2005 M11 ; or ”.

(6) In paragraph (11)—

(a) for “competent authority of a member State” substitute “ licensing authority ”; and

(b) insert “ UK ” before “marketing authorisation”.

Textual Amendments

F37 Reg. 28(1A) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 18(a)

F38 Reg. 28(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 18(b)

F39 Reg. 28(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 18(c)

F40 Reg. 28(4) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 18(d)

Commencement Information

I17 Reg. 28 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M10 Regulation 37 was substituted by S.I. 2013/1855.

M11 S.I. 2005/50. It has been amended by S.I. 2005/1098 and 2898, 2006/2013, 2007/604, 2008/525 and 941, 2009/372 and 3307, 2010/554, 2016/604, 2017/1320 and 2018/231.

Amendment of regulation 38 (imports) U.K.

29.—(1) Regulation 38 M12 is amended as follows.

[F41 (2) In the heading, after “states other than EEA states” insert “/ countries other than approved countries for import”.]

[F42 (3) In paragraph (2) for “from a state other than an EEA State” substitute—

“from—

(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”.]

[F43 (4) In paragraph (3)(b) for “a state other than an EEA State” substitute “, 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”.]

Textual Amendments

F41 Reg. 29(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 19(a)

F42 Reg. 29(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 19(b)

F43 Reg. 29(4) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 19(c)

Commencement Information

I18 Reg. 29 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M12 Regulation 38 was amended by S.I. 2015/1503.

Amendment of regulation 39 (further requirements for manufacturer's licence) U.K.

30.— [F44 (a)] In regulation 39(8) M13 , omit “, 43A” [F45 and

(b) after “and (6)” insert “ and, where the product is being distributed in Northern Ireland, regulation 43A, ”.]

Textual Amendments

F44 Words in reg. 30 renumbered as reg. 30(a) (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 20(a)

F45 Reg. 30(b) and word inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 20(b)

Commencement Information

I19 Reg. 30 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M13 Regulation 39 was amended by S.I. 2013/1855, 2015/354 and 2019/62.

Amendment of regulation 42 (conditions for wholesale dealer's licence) U.K.

31.—(1) Regulation 42 M14 is amended as follows.

[F46 (2) In paragraph (1), after “45” insert “(in the case of a wholesale dealer’s licence held in Northern Ireland) or regulations 43 to 45AA (in the case of a wholesale dealer’s licence held in Great Britain)”.]

[F47 (3) In paragraph (4)—

(a) for “The requirements” substitute “Where a wholesale dealer’s licence relates to wholesale dealings in Northern Ireland, the requirements”; and

(b) for “provisions of a wholesale dealer’s” substitute “provisions of that”.]

Textual Amendments

F46 Reg. 31(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 21(a)

F47 Reg. 31(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 21(b)

Commencement Information

I20 Reg. 31 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M14 Regulation 42 was amended by S.I. 2013/1855 and 2019/62.

Amendment of Schedule 7 (qualified persons) U.K.

32.—(1) Schedule 7 M15 is amended as follows.

(2) In Part 1—

(a) in paragraph 3, for “the member State in which it is studied” substitute “ the licensing authority ”;

(b) in paragraph 6, for “the member State in which the courses take place” substitute “ the licensing authority ”.

(3) In Part 3 (obligations of qualified person)—

(a) in paragraph 12—

(i) the existing text becomes sub-paragraph (1),

[F48 (ia) for “The qualified person” substitute “In Great Britain, the qualified person”;]

(ii) in paragraph (a) of that sub-paragraph—

[F49 (zaa) for “the United Kingdom” substitute “Great Britain”;]

(aa) for “marketing authorisation, Article 126a authorisation” substitute “ UK marketing authorisation ”,

(bb) after “herbal registration” insert “ , or an equivalent authorisation, ”, and

(cc) insert “ and ” at the end,

(iii) in paragraph (b) of that sub-paragraph—

(aa) for “medicinal products imported from [F50 a country other than Northern Ireland or] a non-EEA State, irrespective of whether the products have been manufactured in an EEA State” substitute “ medicinal 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 ”, and

(bb) in paragraph (iii), for “marketing authorisation, Article 126a authorisation” substitute “ UK marketing authorisation ”, and

(cc) after “herbal registration” insert “ , or an equivalent authorisation, ”,

(iv) omit paragraph (c) of that sub-paragraph, and

(v) after that sub-paragraph insert—

“(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.”.

[F51 (aa) after paragraph 12 insert—

“12A.— (1) In Northern Ireland, the qualified person is responsible for securing—

(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; and

(c) in the case of medicinal products, other than radiopharmaceuticals, that are required to bear safety features pursuant to Article 54a of the 2001 Directive and not intended to be exported to a country other than an EEA State, that the features specified in paragraph 18A of Schedule 24 have been affixed on the packaging.”.]

[F52 (b) in paragraph 13—

(i) in sub-paragraph (1) after “This paragraph applies” insert “in Northern Ireland”;

(ii) in sub-paragraph (1)(a) for “paragraph 12 in another member State is imported to the United Kingdom” substitute “paragraph 12A in a member State is imported to Northern Ireland”;

(iii) in sub-paragraph (2) for “12” substitute “12A”;]

(c) in paragraph 14—

[F53 (i) in sub-paragraph (1)(a) after “are imported” insert “into Great Britain from a country other than an approved country for import or into Northern Ireland;]

[F54 (ii) for sub-paragraph (1)(b) substitute—

“(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.”.]

[F55 (iia) in paragraph (2) after “paragraph 12” insert “or 12A”.]

(iii) at the end insert—

“(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

F48 Reg. 32(3)(ia) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(a)

F49 Reg. 32(3)(a)(ii)(zaa) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(b)

F50 Words in reg. 32(3)(a)(iii)(aa) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(c)

F51 Reg. 32(3)(aa) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(d)

F52 Reg. 32(3)(b) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(e)

F53 Reg. 32(3)(c)(i) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(f)(i)

F54 Reg. 32(3)(c)(ii) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(f)(ii)

F55 Reg. 32(3)(c)(iia) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(f)(iii)

Commencement Information

I21 Reg. 32 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M15 Schedule 7 was amended by S.I. 2019/62.

Amendment of regulation 43 (obligations of licence holder) U.K.

33.—(1) Regulation 43 M16 is amended as follows.

[F56 (2) For paragraph (1), substitute—

“43.— (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.”.]

[F57 (3) For paragraph (5)(a) substitute—

“(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), and EU marketing authorisation or an Article 126a authorisation (an “authorisation”),

in force in relation to the product; and”.]

(4) In paragraph (6)—

(a) in sub-paragraph (a), insert at the end “ in the United Kingdom ”; and

[F58 (aa) in sub-paragraph (b), after “the export” insert “from Northern Ireland”;]

(b) [F59 after sub-paragraph (b), insert]—

[F60 “(ba)] the export [F61 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.”.

[F62 (c) for sub-paragraph (d) substitute—

“(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.”.]

(5) In paragraph (7)—

(a) in sub-paragraph (b)—

[F63 (i) for sub-paragraph (i) substitute—

“(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”;]

[F64 (ii) for sub-paragraph (ii) substitute—

“(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), EU marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration,

for, the product; and”;]

[F65 (b) in sub-paragraph (c)(vii), before “the batch number” insert “where the receipt, dispatch or brokering of medicinal products takes places in Northern Ireland,”;]

[F66 (5A) In paragraph (8)—

(a) after “A licence holder” insert “in Northern Ireland”;

(b) for “third country” substitute ““country other than an EEA State”.]

(6) [F67 After paragraph (8) insert] —

[F68 “(8A)] [F69 Paragraph (8B)] applies to a person (“P”) who—

(a) imports [F70 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.

[F68 (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.”.

[F71 (7) In paragraph (10), after “The holder” insert “of a licence relating to wholesale dealings in Northern Ireland”.]

[F72 (8) In paragraph (13), for “marketing authorisation holder” substitute “UK marketing authorisation holder or EU marketing authorisation holder”.]

[F73 (9) For paragraph (14) substitute—

“(14) Where 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.”.

(10) In paragraph (15), after “In this regulation” insert “as it applies in the case of a product for sale or supply in Northern Ireland”.]

Textual Amendments

F56 Reg. 33(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(a)

F57 Reg. 33(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(b)

F58 Reg. 33(4)(aa) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(c)

F59 Words in reg. 33(4)(b) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(d)(i)

F60 Words in reg. 33(4)(b) renumbered (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(d)(ii)(aa)

F61 Words in reg. 33(4)(b) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(d)(ii)(bb)

F62 Reg. 33(4)(c) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(e)

F63 Reg. 33(5)(a)(i) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(f)(i)

F64 Reg. 33(5)(a)(ii) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(f)(ii)

F65 Reg. 33(5)(b) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(g)

F66 Reg. 33(5A) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(h)

F67 Words in reg. 33(6) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(i)(i)

F68 Words in reg. 33(6) renumbered (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(i)(ii)

F69 Words in reg. 33(6) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(i)(iii)(aa)

F70 Words in reg. 33(6) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(i)(iii)(bb)

F71 Reg. 33(7) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(j)

F72 Reg. 33(8) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(k)

F73 Reg. 33(9)(10) substituted for reg. 33(9) (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(l)

Commencement Information

I22 Reg. 33 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M16 Regulation 43 was amended by S.I. 2013/1855 and 2016/186.

[F74 Amendment of regulation 43A (requirement for wholesale dealers to decommission the unique identifier) U.K.

34.   In regulation 43A—

(a) in paragraph (2) for “in the United Kingdom” substitute “in Northern Ireland”; and

(b) in paragraph (3)—

(i) in sub-paragraph (g) omit “a police force in England, Wales or Scotland or”; and

(ii) in sub-paragraph (l) for “care” substitute “nursing”.]

Textual Amendments

F74 Reg. 34 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 24

Commencement Information

I23 Reg. 34 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 44 (requirement for wholesale dealers to deal only with specified persons) U.K.

35.—(1) Regulation 44 M17 is amended as follows.

(2) In paragraph (2)—

[F75 (a) in sub-paragraph (b), for “another EEA State” substitute “an 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)”; and]

[F76 (b) for sub-paragraph (c) substitute—

“(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.”.]

[F77 (3) For paragraph (5)(b) substitute—

“(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;”.]

[F78 (4) For paragraph (5)(e) substitute—

“(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.”.]

(5) In paragraph (6)—

(a) insert “ and ” at the end of sub-paragraph (c); and

[F79 (b) in sub-paragraph (e) after “of the 2001 Directive” insert “, in the case of a licence holder in Northern Ireland.”.]

[F80 (6) After paragraph (7) insert—

“(8) A licence holder in Great Britain may only obtain a medicinal product in respect of which a UKMA(GB) 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

F75 Reg. 35(2)(a) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 25(a)(i)

F76 Reg. 35(2)(b) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 25(a)(ii)

F77 Reg. 35(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 25(b)

F78 Reg. 35(4) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 25(c)

F79 Reg. 35(5)(b) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 25(d)

F80 Reg. 35(6) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 25(e)

Commencement Information

I24 Reg. 35 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M17 Regulation 44 was amended by S.I. 2013/1855, 2015/1503 and 2016/186.

Amendment of regulation 45 (requirement as to responsible persons) U.K.

36.—(1) Regulation 45 is amended as follows.

[F81 (2) After paragraph (1) insert—

“(1A) In respect of a licence holder in Great Britain, paragraph (1) is subject to regulation 45AA.”.]

[F82 (3) For paragraph (2)(b) substitute—

“(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, Article 126a authorisations, certificates of registration or traditional herbal registrations,

applicable to those products.”.]

Textual Amendments

F81 Reg. 36(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 26(a)

F82 Reg. 36(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 26(b)

Commencement Information

I25 Reg. 36 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Insertion of new regulations 45AA and 45AB (responsible persons: import) U.K.

37.  After regulation 45, insert—

“Requirement as to responsible persons where licence holder imports from an approved country for import

45AA.— (1) Subject to paragraph (2), this regulation applies [F83 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; F84 ...

(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 [F85 ; 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.

Register for responsible persons (import)

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

F83 Words in reg. 37 inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 27(a)

F84 Word in reg. 37 omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 27(b)

F85 Words in reg. 37 inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 27(c)

Commencement Information

I26 Reg. 37 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Amendment of regulation 45A (brokering in medicinal products) U.K.

38.—(1) Regulation 45A M18 is amended as follows.

[F86 (2) For paragraph (1) substitute—

“(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—

(i) under Regulation (EC) No 726/2004,

(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.”.]

[F87 (3) In paragraph (2)—

(a) after “paragraph (1)(b)” insert “or (1A)(b)”;

(b) in sub-paragraphs (a) and (c), after “competent authority of a member State” insert “or the licensing authority (as appropriate)”.]

(4) Omit paragraph (3).

Textual Amendments

F86 Reg. 38(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 28(a)

F87 Reg. 38(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 28(b)

Commencement Information

I27 Reg. 38 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M18 Regulation 45A was inserted by S.I. 2013/1855.

Amendment of regulation 45D (grant or refusal of a broker's registration) U.K.

39.  In regulation 45D(1)(b) M19 omit sub-paragraph (ii) (and “and” immediately preceding it).

Commencement Information

I28 Reg. 39 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M19 Regulation 45D was inserted by S.I. 2013/1855.

Amendment of regulation 45E (criteria of broker's registration) U.K.

40.  M20 In regulation 45E(3) —

[F88 (a) for sub-paragraph (b)(i) substitute—

“(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”;]

[F89 (b) in sub-paragraph (d)(iii), before “the batch number” insert “where the sale or supply of the medicinal product is in Northern Ireland,”.]

Textual Amendments

F88 Reg. 40(a) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 29(a)

F89 Reg. 40(b) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 29(b)

Commencement Information

I29 Reg. 40 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M20 Regulation 45E was inserted by S.I. 2013/1855.

Amendment of regulation 45F (provision of information) U.K.

41.  In regulation 45F(1) M21 for sub-paragraph (b) substitute—

[F90 “(b) in the case of a broker in—

(i) Great Britain, either—

(aa) the UK marketing authorisation holder, or

(bb) where applicable, 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) Northern Ireland, either—

(aa) the UK marketing authorisation holder, or

(bb) where applicable, the EU marketing authorisation holder,”].

Textual Amendments

F90 Words in reg. 41 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 30

Commencement Information

I30 Reg. 41 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M21 Regulation 45F was inserted by S.I. 2013/1855.

Amendment of regulation 45M (criteria for importation, manufacture or distribution of an active substance) U.K.

42.—(1) Regulation 45M M22 is amended as follows.

[F91 (2) For paragraph (2)(a) substitute—

“(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”;]

(3) In paragraph (3), omit “from a state other than an EEA State”.

Textual Amendments

F91 Reg. 42(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 31

Commencement Information

I31 Reg. 42 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M22 Regulation 45M was inserted by S.I. 2013/1855.

Amendment of Schedule 7A (information to be provided for registration as an importer, manufacturer or distributor of active substances) U.K.

43.—(1) Schedule 7A M23 is amended as follows.

(2) In paragraph 13(b), omit “from third countries”.

(3) In paragraph 15(c), omit “to a third country”.

Commencement Information

I32 Reg. 43 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M23 Schedule 7A was inserted by S.I. 2013/1855.

Amendment of regulation 45O (requirements for registration as an importer, manufacturer or distributor of an active substance) U.K.

44.—(1) Regulation 45O M24 is amended as follows.

[F92 (2) For paragraph (1) substitute—

“(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.”.]

[F93 (3) For paragraph (2) substitute—

“(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.”.]

[F94 (4) In paragraph (3)—

(a) for “the UK” substitute “Northern Ireland”;

(b) for “from a third country” substitute “into Northern Ireland from a country other than an EEA State”;

(c) for “exporting third country” in both places it occurs substitute “exporting country”;

(d) in sub-paragraph (c)(ii), for “the Union” substitute “Northern Ireland”.]

[F95 (4A) After paragraph (3) insert—

“(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.”.]

[F96 (5) In paragraph (4)—

(a) for “(3)(c) does” substitute “(3)(c) and (3A)(c) do”;

(b) in sub-paragraph (a), after “Article 111b of the 2001 Directive” insert “(in the case of an import into Northern Ireland) or paragraph (6) (in the case of an import into Great Britain)”;

(c) in sub-paragraph (b)(i), after “competent authority of a member State” insert “or 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)”.]

(6) At the end insert—

“(6) The licensing authority may publish a list of countries which it is satisfied have a regulatory framework applicable to active substances exported to [F97 Great Britain] that is equivalent to the regulatory framework in [F97 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

F92 Reg. 44(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 32(a)

F93 Reg. 44(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 32(b)

F94 Reg. 44(4) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 32(c)

F95 Reg. 44(4A) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 32(d)

F96 Reg. 44(5) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 32(e)

F97 Words in reg. 44(6) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 32(f)

Commencement Information

I33 Reg. 44 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M24 Regulation 45O was inserted by S.I. 2013/1855.