# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 222: Amendment of regulation 331 (findings and reports of inspections)

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

(1) Regulation 331 is amended as follows.
(2) In paragraph (1)—
(a) for “marketing authorisation” substitute “UK marketing authorisation, EU marketing authorisation”;
(b) in sub-paragraph (c), at the beginning, insert “in the case of a product authorised under a UKMA(NI) or UKMA(UK),”.
(3) In paragraph (4)—
(a) for sub-paragraph (b) substitute—
“(b) the guidelines on good distribution practice—
(i) in the case of Great Britain, published under, or that apply by virtue of, regulation C17;
(ii) in the case of Northern Ireland, published by the European Commission in accordance with Article 84 of the 2001 Directive;”;
(b) after sub-paragraph (c) insert—
“(d) Schedule 12A; and
(e) the Implementing Regulation (as defined in regulation 177(5)).”.

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Source: https://www.legislation.gov.uk/uksi/2019/775/regulation/222 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-222
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.