# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 74: Amendment of regulation 66 (application for renewal of authorisation)

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

In regulation 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/uksi/2019/775/regulation/74 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-74
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.