# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 194A: Amendment of regulation 251 (compliance with standards specified in certain publications)


In regulation 251 (compliance with standards specified in certain publications), after paragraph (5) insert—
“(6) In paragraph (1), (2) or (3) a product is to be treated as complying with the standard specified in the relevant monograph where—
(a) the product complies with the standard specified in a relevant marketing authorisation for the product concerned, and
(b) the standard specified in that marketing authorisation does not comply with the standard specified in the relevant monograph.
(7) In paragraph (6), “relevant marketing authorisation” means—
(a) an EU marketing authorisation;
(b) an authorisation granted by the licencing authority under Chapter 4 of Title III to the 2001 Directive; or
(c) a UKMA(GB) granted under the unfettered access route.”.

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Source: https://www.legislation.gov.uk/uksi/2019/775/regulation/194A (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-194A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.