# The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024, Regulation 25: Amendment to regulation 48

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

(1) Regulation 48 (application of Part) is amended as follows.
(2) In paragraph (2)—
(a) omit the definition of “EU reference medicinal product”;
(b) in the definition of “excluded reference product”, in paragraph (c), for “53A(1)” substitute “53B(1)”;
(c) in the definition of “generic medicinal product”—
(i) in paragraph (a), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”;
(ii) in paragraph (b), in the opening words, for “UKMA(GB)” substitute “UKMA(UK)(Category 1)”;
(d) in the definition of “reference medicinal product”—
(i) omit paragraph (b);
(ii) in paragraph (c)—
(aa) at the end of sub-paragraph (i), for “; or” substitute a comma;
(bb) omit sub-paragraph (ii).
(3) In paragraph (7), for “51A(1) and (6)” substitute “51B(1) and (6)”.
(4) Omit paragraphs (8) and (9).

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Source: https://www.legislation.gov.uk/uksi/2024/832/regulation/25 (the official version)
Page: https://openlegislation.uk/human-medicines-amendments-relating-to-the-windsor-framework-regulations-2024/regulation-25
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.