# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 192


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”.

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Source: https://www.legislation.gov.uk/ukdsi/2020/9780348213980/schedule/2/paragraph/192 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-192
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.