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

Amendment of regulation 205 (obligations on holders in relation to public announcements) U.K.

166.—(1) Regulation 205 is amended as follows.

(2) In paragraph (2), [F1 after “bodies listed in paragraph (3)” insert “where the product is subject to a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation, or the licensing authority where the product is subject to a UKMA(GB) or THR(GB),”]

F2 (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Words in reg. 166(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. 133(a)

F2 Reg. 166(3) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 133(b)

Commencement Information

I1 Reg. 166 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1