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


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/ukdsi/2020/9780348213980/schedule/2/paragraph/57 (the official version)
Page: https://openlegislation.uk/draft-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.