The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 No. 1488

SCHEDULES

SCHEDULE 2 U.K. Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 10 U.K. Amendment of Part 11 (amendment of Part 11 (Pharmacovigilance))

124.  In regulation 156 (substitution of regulation 196 (urgent action))— U.K.

(a) for the heading to the regulation, substitute “ Insertion of new regulation 196A (major safety review by the licensing authority) ”;

(b) for “For regulation 196 and the italic heading immediately preceding it, substitute” substitute “ After regulation 196 insert ”;

(c) in the text to be inserted by that regulation—

(i) omit the italic heading “Major safety review”;

(ii) renumber the regulation as regulation 196A.

Commencement Information

I1 Sch. 2 para. 124 in force at 31.12.2020 immediately before IP completion day, see reg. 1