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

Amendment of regulation 45 (requirement as to responsible persons) U.K.

36.—(1) Regulation 45 is amended as follows.

[F1 (2) After paragraph (1) insert—

“(1A) In respect of a licence holder in Great Britain, paragraph (1) is subject to regulation 45AA.”.]

[F2 (3) For paragraph (2)(b) substitute—

“(b) ensuring that the quality of medicinal products handled by the licence holder is being maintained in accordance with the requirements of—

(i) in the case of a licence holder in Great Britain, the UK marketing authorisations, certificates of registration or traditional herbal registrations, and

(ii) in the case of a licence holder in Northern Ireland, the marketing authorisations, Article 126a authorisations, certificates of registration or traditional herbal registrations,

applicable to those products.”.]

Textual Amendments

F1 Reg. 36(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. 26(a)

F2 Reg. 36(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. 26(b)

Commencement Information

I1 Reg. 36 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1