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 21 U.K. Amendment of Schedule 6 (insertion of new Schedule 12A (further provision as to the performance of pharmacovigilance activities))

192.  In Schedule 6 (insertion of new Schedule 12A (further provision as to the performance of pharmacovigilance activities)), in the inserted Schedule 12A— U.K.

(a) in paragraphs 1(3), 12(5), 16(3), 22(1)(d) and 30(g), for “UK marketing authorisation” substitute “ UKMA(GB) ”;

(b) in paragraph 2(a)—

(i) at the end of paragraph (iii) omit “and”;

(ii) in paragraph (iv), for “pharmacovigilance;” substitute “ pharmacovigilance, and ”;

(iii) after paragraph (iv) insert—

“(v) responsibilities and contact details of the nominated person (where a person is nominated under regulation 182(2A));”;

(c) in paragraph 2(d), for “handing” substitute “ handling ”;

(d) omit paragraph 4(4);

(e) in paragraph 7—

(i) omit sub-paragraph (1);

(ii) in sub-paragraph (2)—

(aa) after “qualified person” insert “ and nominated person (where a person is nominated under regulation 182(2A)) ”;

(bb) for “has” substitute “ have ”.

Commencement Information

I1 Sch. 2 para. 192 in force at 31.12.2020 immediately before IP completion day, see reg. 1