# The Human Medicines (Amendment etc.) (EU Exit) (No. 2) Regulations 2021, Regulation 8: Amendment of regulation 49 (application for grant of UK marketing authorisation or parallel import licence)


(1) Regulation 49 is amended as follows.
(2) For paragraph (3)(a) substitute—
“(a) a UKMA(UK) or UKMA(NI), must be established in the United Kingdom or the European Union;”.
(3) In paragraph (3)(b)(ii), after “the United Kingdom” insert “or the European Union”.
(4) In paragraph (3)(c), for “UKMA(UK)” substitute “parallel import licence”.

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Source: https://www.legislation.gov.uk/ukdsi/2021/9780348228755/regulation/8 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-no-2-regulations-2021/regulation-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.