# The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024, Regulation 51: Amendment to regulation 61

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

In regulation 61 (conditions of UK marketing authorisation: new obligations post-authorisation)—
(a) in paragraph (4)(b), after “UKMA(GB)” insert “or UKMA(UK)(Category 1)”;
(b) in paragraph (6), for “or UKMA(UK)” substitute “or UKMA(UK)(Category 2)”;
(c) in paragraph (6A), after “UKMA(GB)” insert “or UKMA(UK)(Category 1)”;
(d) for paragraph (7), substitute—
“(7) The obligation under paragraph (5) must be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive while taking account of the scientific guidance that applies under regulation 205B in relation to post-authorisation efficacy studies.”;
(e) omit paragraph (7A);
(f) in paragraph (13), for “or UKMA(UK)” substitute “or UKMA(UK)(Category 2)”.

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Source: https://www.legislation.gov.uk/uksi/2024/832/regulation/51 (the official version)
Page: https://openlegislation.uk/human-medicines-amendments-relating-to-the-windsor-framework-regulations-2024/regulation-51
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.