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The Human Medicines Regulations 2012

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The Human Medicines Regulations 2012, Cross Heading: Exemptions relating to supply in specific circumstances is up to date with all changes known to be in force on or before 29 March 2024. 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. Help about Changes to Legislation

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Changes and effects yet to be applied to the whole Instrument associated Parts and Chapters:

Whole provisions yet to be inserted into this Instrument (including any effects on those provisions):

  • Sch. 11 para. 1(1)(d)-(f) inserted by S.I. 2019/775 reg. 63(2)(a)(ii) (This amendment not applied to legislation.gov.uk. Reg. 63(2)(a)(ii) substituted immediately before IP completion day by S.I. 2019/1385, reg. 1, Sch. 1 para. 7(2))
  • Sch. 33A para. 57A inserted by S.I. 2019/775, Sch. 7 (as amended) by S.I. 2019/1385 Sch. 1 para. 10(4) (This amendment not applied to legislation.gov.uk. Sch. 1 para. 10(3)(4) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(c))
  • Sch. 33A para. 57(3) substituted by S.I. 2019/775, Sch. 7 (as amended) by S.I. 2019/1385 Sch. 1 para. 10(3)(b) (This amendment not applied to legislation.gov.uk. Sch. 1 para. 10(3)(4) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(c))
  • Sch. 33A para. 57(2) words inserted by S.I. 2019/775, Sch. 7 (as amended) by S.I. 2019/1385 Sch. 1 para. 10(3)(a) (This amendment not applied to legislation.gov.uk. Sch. 1 para. 10(3)(4) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(c))
  • reg. 51(9) words inserted by S.I. 2019/775, reg. 56 (as amended) by S.I. 2019/1385 Sch. 1 para. 5 (This amendment not applied to legislation.gov.uk. Sch. 1 paras. 2-6 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(a))
  • reg. 52(1)(a)(i)(ii) and words substituted by S.I. 2019/775 reg. 57(2) (This amendment not applied to legislation.gov.uk. Reg. 57 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 42)
  • reg. 53(2)-(2C) substituted for reg. 53(2) by S.I. 2019/775 reg. 58(3) (This amendment not applied to legislation.gov.uk. Reg. 58 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 43)
  • reg. 53(2)(a) substituted by S.I. 2019/775, reg. 58(3) (as amended) by S.I. 2019/1385 Sch. 1 para. 6(2) (This amendment not applied to legislation.gov.uk. Sch. 1 paras. 2-6 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(a))
  • reg. 173(e) inserted by S.I. 2017/1322 Sch. 4 para. 2(2)(b) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(i).)
  • reg. 240(2A) words inserted by S.I. 2017/1322 Sch. 4 para. 2(3)(c) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(ii).)
  • reg. 240(6A) inserted by S.I. 2017/1322 Sch. 4 para. 2(3)(g) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(ii).)
  • reg. 247A(7) inserted by S.R. 2024/68 reg. 5(4)
  • reg. 247A(7) inserted by S.I. 2024/344 reg. 5(4)

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,

[F1(vi)a nurse independent prescriber,

(vii)a community practitioner nurse prescriber,

(viii)a podiatrist independent prescriber, F2...

(ix)a physiotherapist independent prescriber]F3...

[F4(x)a therapeutic radiographer independent prescriber][F5, 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

F1Reg. 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

F2Word 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)

F3Word 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)

F4Reg. 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)

F5Reg. 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 [F6product 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

F6Words 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 [F7product 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

F7Words 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.

[F8Sale 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, F9...

(iii)radiographers: diagnostic or therapeutic; or

[F10(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

F9Word 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 [F11and local authorities] U.K.

229.—(1) Regulations 214(1) [F12and (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;

[F13(da)a local authority in the exercise of public health functions (within the meaning of the National Health Service Act 2006); F14...]

[F15(db)Public Health England;

(dc)Public Health Agency; or]

F16(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 [F17[F18an integrated care board], [F19NHS England] or] one of the persons specified in paragraphs (a) [F20to [F21(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 [F22, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber] [F23, paramedic independent prescriber] or pharmacist independent prescriber relating to that person, regardless of whether the directions comply with regulation 217 (requirements for prescriptions).

[F24(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

[F25(f)when the product is supplied [F26, either an authorisation by the licensing authority on a temporary basis under regulation 174 or]

(i)in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), [F27or, 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.]

F28(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F14Word 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)

F15Reg. 229(1)(db)(dc) inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 4(2)(b) and reg. 229(1)(db)(dc) inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 4(2)(b)

F21Word 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)

F22Words 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

F23Words 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[F29, 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 M1, 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.

[F30(8) Condition G is that when the product is supplied or (as the case may be) administered [F31, either an authorisation by the licensing authority on a temporary basis under regulation 174 or]

(a)in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), [F32or, 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.]

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 M2 in respect of one or more of the following regulated activities M3

(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.

[F33(8) Condition G is that when the product is supplied [F34, either an authorisation by the licensing authority on a temporary basis under regulation 174 or]

(a)in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK) [F35or, 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

M3Regulated 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 M4, 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.

[F36(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

M42008 No. 1976 (W. 185).

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,

[F37(iva)[F18an integrated care board],

(ivb)[F19NHS England],

(ivc)a local authority in the exercise of public health functions (within the meaning of the National Health Service Act 2006),]

[F38(ivd)Public Health England,

(ive)Public Health Agency,]

F39(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) [F40to (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.

[F41(7) Condition F is that when the prescription only medicine is supplied or (as the case may be) administered [F42, either an authorisation by the licensing authority on a temporary basis under regulation 174 or]

(a)in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK) [F43or, 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.]

[F44(8) Regulation 220 does not apply to the supply, or administration, of a prescription only medicine used for vaccination or immunisation against coronavirus or influenza virus where paragraph (1)(a) and (b) applies and conditions A to F are met.

F45(9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Textual Amendments

F38Reg. 233(1)(a)(ivd)(ive) inserted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 7(2) and reg. 233(1)(a)(ivd)(ive) inserted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 7(2)

F40Words 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)

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;

[F46(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.

[F47(9) Condition H is that when the product is supplied [F48, either an authorisation by the licensing authority on a temporary basis under regulation 174 or]

(a)in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), [F49or, 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.]

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.

F50(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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