# 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)

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

(1) Regulation 45M is amended as follows.
(2) For paragraph (2)(a) substitute—
“(a) if—
(i) in the case of a product for sale or supply in Great Britain, the product has a UK marketing authorisation, certificate of registration or traditional herbal registration, or
(ii) in the case of a product for sale or supply in Northern Ireland, the product has a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration, and”;
(3) In paragraph (3), omit “from a state other than an EEA State”.

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Source: https://www.legislation.gov.uk/uksi/2019/775/regulation/42 (the official version)
Page: https://openlegislation.uk/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.