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


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/ukdsi/2020/9780348213980/schedule/2/paragraph/137 (the official version)
Page: https://openlegislation.uk/draft-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.