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))

108.  After regulation 139 (amendment of regulation 177 (application of part and interpretation)) insert— U.K.

“Amendment of regulation 179 (obligation on licensing authority to operate pharmacovigilance system)

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 ”.”.

Commencement Information

I1 Sch. 2 para. 108 in force at 31.12.2020 immediately before IP completion day, see reg. 1