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


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/ukdsi/2020/9780348213980/schedule/2/paragraph/66 (the official version)
Page: https://openlegislation.uk/draft-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.