Paragraph 192 I1

United Kingdom

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

(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 ”.

Annotations

Commencement

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