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

PART 14 U.K. Amendment of Part 13 (packaging and leaflets)

Amendment of regulation 268 (offence relating to packaging and package leaflets) U.K.

207.—(1) Regulation 268 M1 is amended as follows.

[F1 (1A) In the heading to the regulation, after “packaging and package leaflets” insert “in Great Britain”.]

[F2 (2) In paragraph (1)—

(a) for “marketing authorisation, Article 126a authorisation” substitute “UKMA(UK), UKMA(GB)”;

(b) after “the purpose of sale or supply” insert “, in Northern Ireland”.]

(3) In paragraph (2)(a)—

(a) for “Article 28 or 32 of the Paediatric Regulation” substitute “ regulation 50C(4), 50D(8) or 58A(2)(b) ”; and

(b) omit “, Article 9 of Commission Regulation 2016/161”.

Textual Amendments

F1 Reg. 207(1A) inserted (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. 161(a)

F2 Reg. 207(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. 161(b)

Commencement Information

I1 Reg. 207 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 268 was amended by S.I. 2019/62.