# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 137

Extent: E+W+S+N.I.

In regulation 175 (amendment of regulation 210A (offences in relation to pharmacovigilance obligations under the Implementing Regulation))—
(a) in paragraph (2)—
(i) for “for” substitute “ after ”;
(ii) for “substitute “Schedule 12A”” substitute “ insert “and Schedule 12A” ”;
(b) in paragraph (3) for sub-paragraphs (a) and (b) substitute—
“(a) in sub-paragraph (a), at the beginning insert “ in relation to a UKMA(NI), UKMA(UK), THR(NI) THR(UK) or Article 126a authorisation, ”;
(b) after sub-paragraph (a) insert—
“(aa) in relation to a UKMA(GB) or THR(GB), fails to comply with any requirement or obligation contained in a provision of Schedule 12A listed in paragraph (2A); or”.”;
(c) in paragraph (4)—
(i) for “For paragraph (2) substitute” substitute “ After paragraph (2) insert ”;
(ii) the inserted paragraph (2) becomes inserted paragraph (2A);
(iii) omit the inserted paragraphs (3) and (4);
(d) after paragraph (4) insert—
“(5) In paragraph (4), after “Implementing Regulation” insert “ , or of paragraph 26(8) or 29(1) of Schedule 12A, ”.”.

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Source: https://www.legislation.gov.uk/uksi/2020/1488/schedule/2/paragraph/137 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-137
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.