PART 3 U.K.Amendment of Part 3 (manufacture and distribution of medicinal products and active substances)

Amendment of regulation 45E (criteria of broker's registration) U.K.

40.  M1 In regulation 45E(3) —

[F1 (a) for sub-paragraph (b)(i) substitute—

“(i) ordered by—

(aa) in the case of a broker in Great Britain, the licensing authority or by an appropriate authority responsible for the licensing of medicinal products in an approved country for import, or

(bb) in the case of a broker in Northern Ireland, the licensing authority or by the competent authority of any EEA State, or”;]

[F2 (b) in sub-paragraph (d)(iii), before “the batch number” insert “where the sale or supply of the medicinal product is in Northern Ireland,”.]

Textual Amendments

F1 Reg. 40(a) 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. 29(a)

F2 Reg. 40(b) 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. 29(b)

Commencement Information

I1 Reg. 40 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 45E was inserted by S.I. 2013/1855.