The Human Medicines Regulations 2012

Exemption for supply etc under a PGD to assist doctors or dentists U.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[F1 , 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.

[F2 (8) Condition G is that when the product is supplied or (as the case may be) administered [F3 , 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), [F4 or, 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

F1 Words in reg. 230(6)(a) substituted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(4) (with Sch. 3 para. 28)

F2 Reg. 230(8) substituted (31.12.2020) by S.I. 2019/775, reg. 188 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 142)

F3 Words in reg. 230(8) inserted (31.12.2020 immediately after S.I. 2019/775 comes into force) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(3), 6 and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(3), 6

F4 Words in reg. 230(8)(a) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 18

Marginal Citations

M1 1978 c.29.