# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 55


In regulation 74 (amendment of regulation 66 (application for renewal of authorisation)) for “66(2)” to the end substitute—
“66, for paragraph (2) substitute—
“(2) The applicant, where it is applying for renewal of—
(a) a UKMA(NI)—
(i) in accordance with Chapter 4 of Title III of the 2001 Directive, must be established in the European Union;
(ii) on any other basis, must be established in the United Kingdom;
(b) a UKMA(GB)—
(i) under the unfettered access route, must be established in Northern Ireland;
(ii) other than under the unfettered access route, must be established in the United Kingdom;
(c) a UKMA(UK), must be established in the United Kingdom.”.”;

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Source: https://www.legislation.gov.uk/ukdsi/2020/9780348213980/schedule/2/paragraph/55 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-55
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.