# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 42: Amendment of regulation 45M (criteria for importation, manufacture or distribution of an active substance)


(1) Regulation 45M is amended as follows.
(2) In paragraph (2)(a), for “marketing authorisation, Article 126a authorisation” substitute “UK marketing authorisation”.
(3) In paragraph (3), omit “from a state other than an EEA State”.

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Source: https://www.legislation.gov.uk/ukdsi/2019/9780111179185/regulation/42 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-42
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.