# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 175: Amendment of regulation 210A (offences in relation to pharmacovigilance obligations under the Implementing Regulation)

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

(1) Regulation 210A is amended as follows.
(2) In the heading, after “the Implementing Regulation insert “and Schedule 12A”.
(3) In paragraph (1)—
(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”.
(4) After paragraph (2) insert—
“(2A) The provisions of Schedule 12A mentioned in paragraph (1)(a) are—
(a) Part 1 (pharmacovigilance system master file);
(b) Parts 2 and 3 (minimum requirements for the quality systems in the performance of pharmacovigilance activities);
(c) Part 6 (transmission of reports of suspected adverse reactions);
(d) paragraph 24 (update of risk management plans);
(e) Part 8 (periodic safety update reports); and
(f) Part 9 (post-authorisation safety studies).
(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .”.
(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/2019/775/regulation/175 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-175
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.