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

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

38.—(1) Regulation 45A M1 is amended as follows.

[F1 (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.”.]

[F2 (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

F1 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)

F2 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

I1 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

M1 Regulation 45A was inserted by S.I. 2013/1855.