# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 181


In regulation 222 (amendment of regulation 331 (findings and reports of inspections))—
(a) for paragraph (2) substitute—
“(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),”.”;
(b) for paragraph (3) substitute—
“(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/ukdsi/2020/9780348213980/schedule/2/paragraph/181 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-181
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.