The Human Medicines Regulations 2012

Exemption for supply etc under a PGD by independent hospitals etc U.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 M1 in respect of one or more of the following regulated activities M2 —

(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.

[F1 (8) Condition G is that when the product is supplied [F2 , 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) [F3 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 Reg. 231(8) substituted (31.12.2020) by S.I. 2019/775, reg. 189 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 143)

F2 Words in reg. 231(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), 7 and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(3), 7

F3 Words in reg. 231(8)(a) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 19

Marginal Citations

M1 2008 c.14.

M2 Regulated 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.