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))

134.  In regulation 167 (insertion of regulation 205A (further obligations in respect of pharmacovigilance activities)), in the inserted regulation 205A— U.K.

(a) in paragraph (1), after “Schedule 12A” insert “ applies in relation to medicinal products for sale or supply under a UKMA(GB) or THR(GB) and ”;

(b) in paragraph (2)—

(i) for “The Ministers” substitute “ The Secretary of State ”;

(ii) after “by regulations” insert “ in respect of Great Britain ”.

Commencement Information

I1 Sch. 2 para. 134 in force at 31.12.2020 immediately before IP completion day, see reg. 1