The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 No. 775

PART 17 U.K. Amendment of Part 16 (enforcement)

Amendment of regulation 331 (findings and reports of inspections) U.K.

222.—(1) Regulation 331 is amended as follows.

[F1 (2) In paragraph (1)—

(a) for “marketing authorisation” substitute “UK marketing authorisation, EU marketing authorisation”;

(b) in sub-paragraph (c), at the beginning, insert “in the case of a product authorised under a UKMA(NI) or UKMA(UK),”.]

[F2 (3) In paragraph (4)—

(a) for sub-paragraph (b) substitute—

“(b) the guidelines on good distribution practice—

(i) in the case of Great Britain, published under, or that apply by virtue of, regulation C17;

(ii) in the case of Northern Ireland, published by the European Commission in accordance with Article 84 of the 2001 Directive;”;

(b) after sub-paragraph (c) insert—

“(d) Schedule 12A; and

(e) the Implementing Regulation (as defined in regulation 177(5)).”.]

Textual Amendments

F1 Reg. 222(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. 181(a)

F2 Reg. 222(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. 181(b)

Commencement Information

I1 Reg. 222 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1