# The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, Paragraph 4: Amendment of regulation 47 (amendment of regulation 48 of the 2012 Regulations – application of Part 5)


In regulation 47(2)—
(a) in sub-paragraph (a), in the inserted definition of “EU reference medicinal product”, after “paragraph (b)” insert “or (c)”; and
(b) in sub-paragraph (d), in the substituted definition of “reference medicinal product”—
(i) omit the “or” at the end of paragraph (a); and
(ii) at the end of paragraph (b) insert—
“; or
(c) in relation to which an EU marketing authorisation had ceased to be in force before exit day for reasons not relating to safety, quality or efficacy.”.

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Source: https://www.legislation.gov.uk/ukdsi/2019/9780111189092/schedule/1/paragraph/4 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-and-medical-devices-amendment-etc-eu-exit-regulations-2019/schedule-1/paragraph-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.