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

Amendment of regulation 192 (obligation to submit periodic safety reports: derogation from general requirements) U.K.

152.—(1) Regulation 192 is amended as follows.

(2) In paragraph (1)(a), insert “ UK ” before “marketing authorisation”.

(3) In paragraph (3), [F1 after “EMA” insert “and the licensing authority or, in the case of a holder of a UKMA(GB), to the licensing authority only,]

[F2 (4) In paragraph (9), after “paragraph (3)(a)” insert “from the holder of a UKMA(UK), UKMA(NI), THR(UK), THR(NI) or Article 126a authorisation”.]

Textual Amendments

F1 Words in reg. 152(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. 119(a)

F2 Reg. 152(4) 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. 119(b)

Commencement Information

I1 Reg. 152 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1