# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 28: Amendment of regulation 37 (manufacturing and assembly)


(1) Regulation 37 is amended as follows.
(2) In paragraph (4)(b)—
(a) for “third country” substitute “country other than an approved country for import”; and
(b) for “competent authority of a member State” substitute “appropriate authority for the registration of such persons in the approved country for import”.
(3) In paragraph (5)(b), for “paragraph 5 of Article 47 of the 2001 Directive” substitute “the guidelines which apply under or by virtue of regulation C17”.
(4) In paragraph (6)(b), for “marketing authorisations, Article 126a authorisations” substitute “UK marketing authorisations”.
(5) In paragraph (9)(a), from “Commission” to the end substitute “the Blood Quality and Safety Regulations 2005; or”.
(6) In paragraph (11)—
(a) for “competent authority of a member State” substitute “licensing authority”; and
(b) insert “UK” before “marketing authorisation”.

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Source: https://www.legislation.gov.uk/ukdsi/2019/9780111179185/regulation/28 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-28
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.