The Human Medicines Regulations 2012

[F1Brokering in medicinal productsU.K.

This section has no associated Explanatory Memorandum

45A.—[F2(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—

F3(i). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(ii)by the licensing authority, or

(iii)by a competent authority of a member State, and

(b)that person—

(i)is validly registered as a broker with the licensing authority or a competent authority of a member State,

(ii)except where the person is validly registered with the competent authority of an EEA State, has a permanent address in the United Kingdom, and

(iii)complies with the guidelines on good distribution practice published by the European Commission in accordance with Article 84 of the 2001 Directive insofar as those guidelines apply to brokers.]

(2) A person is not validly registered for the purpose of paragraph (1)(b) [F4or (1A)(b)] if—

(a)the person’s permanent address is not entered into a register of brokers kept by a competent authority of a member State [F5or the licensing authority (as appropriate)];

(b)the registration is suspended; or

(c)the person has notified the competent authority of a member State [F6or the licensing authority (as appropriate)] to remove that person from the register.

F7(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Textual Amendments

F2Reg. 45A(1)(1A) substituted for reg. 45A(1) (31.12.2020) by S.I. 2019/775, regs. 1, 38(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 28(a))