# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 57

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

In regulation 77 (amendment of regulation 68 (revocation, variation and suspension of UK marketing authorisation or parallel import licence))—
(a) in paragraph (3), for sub-paragraph (b) substitute—
“(b) for “established in the European Union” substitute—
“established in—
(a) the United Kingdom; or
(b) in relation to a UKMA(NI), either the United Kingdom or the European Union,
in accordance with the requirements of these Regulations.”.”;
(b) for paragraph (5) substitute—
“(5) In paragraph (9)(a) omit “other than the United Kingdom”.”;
(c) in paragraph (8)—
(i) in the inserted paragraph (11E), for “exit day” in both places it occurs substitute “ IP completion day ”;
(ii) after the inserted paragraph (11F), insert—
“(11G) Condition P is that the licensing authority thinks that the revocation, variation or suspension is necessary or expedient in light of the Protocol on Ireland/Northern Ireland in the withdrawal agreement.”.

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Source: https://www.legislation.gov.uk/uksi/2020/1488/schedule/2/paragraph/57 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-57
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.