PART 11 U.K.Amendment of Part 11 (Pharmacovigilance)

[F1 Amendment of regulation 179 (obligation on licensing authority to operate pharmacovigilance system) U.K.

139A.   In regulation 179—

(a) in paragraph (1), after “pharmacovigilance system” insert “in relation to medicinal products for sale or supply in Great Britain”;

(b) after paragraph (1) insert—

“(1A) The licensing authority must operate a pharmacovigilance system in relation to medicinal products for sale or supply in Northern Ireland.”;

(c) in paragraph (2) for “The pharmacovigilance system” substitute “Each pharmacovigilance system”; and

(d) in paragraph (3)(a) for “the pharmacovigilance system” substitute “each pharmacovigilance system”.]

Textual Amendments

F1 Reg. 139A 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. 108

Commencement Information

I1 Reg. 139A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1