# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 33

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

In regulation 45 (amendment of regulation 46 (requirement for authorisation))—
(a) for paragraph (2)(b) and (c) substitute—
“(b) after sub-paragraph (a) insert—
“(aa) an EU marketing authorisation;”.”;
(b) for paragraphs (4)(a) to (c) substitute—
“(a) after “in force for the product” insert “ in the country in which the product is intended to be sold or supplied, or offered for sale or supply ”;
(b) in sub-paragraph (a), before “marketing authorisation”, insert “ UK ”; and
(c) after sub-paragraph (a) insert—
“(aa) an EU marketing authorisation;”.”;
(c) omit paragraph (5).

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Source: https://www.legislation.gov.uk/uksi/2020/1488/schedule/2/paragraph/33 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-33
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.