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The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

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Changes over time for: Paragraph 192

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There are currently no known outstanding effects for the The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 192. Help about Changes to Legislation

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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

I1Sch. 2 para. 192 in force at 31.12.2020 immediately before IP completion day, see reg. 1

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