# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 66

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

In regulation 89 (amendment of regulation 80 (urgent safety restrictions))—
(a) for paragraph (3) substitute—
“(3) For paragraph (a) substitute—
“(a) fails—
(i) in respect of a UKMA(GB) or UKMA(UK), to inform the licensing authority in accordance with paragraph 14(1) of Schedule 10A, or
(ii) in respect of a UKMA(NI), UKMA(UK) or EU marketing authorisation, to inform the European Commission in accordance with Article 22(1) of Regulation (EC) No 1234/2008,
that the holder has taken urgent safety restrictions on the holder's own initiative;”.”;
(b) for paragraph (4) substitute—
“(4) For paragraph (b) substitute—
“(b) fails—
(i) in respect of a UKMA(GB), to implement an urgent safety restriction imposed on the holder by the licensing authority in accordance with paragraph 14(3) of Schedule 10A, or
(ii) in respect of a UKMA(NI) or UKMA(UK), to implement an urgent safety restriction imposed on the holder by the European Commission under Article 22(2) of Regulation (EC) No 1234/2008; or”.”;
(c) after paragraph (4) insert—
“(4A) In paragraph (c) after “fails” insert “ in respect of a UKMA(NI) ”.”;
(d) in paragraph (5)—
(i) for “For sub-paragraph (c) substitute” substitute “ After paragraph (c) insert ”;
(ii) renumber the paragraph inserted as sub-paragraph (d);
(iii) in the paragraph inserted, after “fails” insert “ in respect of a UKMA(GB) ”.

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Source: https://www.legislation.gov.uk/uksi/2020/1488/schedule/2/paragraph/66 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-66
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.