The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
Write the words of this act the way you think they should read. Solon shows your change as a redline against the published text and pins it to that exact text, so it can never be applied to wording you did not see.
Change 1
51 Amendment to regulation 61
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)”.
51 Amendment to regulation 61
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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