# The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024, Regulation 90: Amendment to regulation 199

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

In regulation 199 (submission of draft study protocols for required studies)—
(a) in paragraph (2)—
(i) in sub-paragraph (a), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”;
(ii) in sub-paragraph (b), after “a UKMA(GB)” insert “or UKMA(UK)(Category 1)”;
(b) in paragraph (3)(b), for “in all other cases” substitute “where the study is to be conducted in the EU or an EEA State”.

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Source: https://www.legislation.gov.uk/uksi/2024/832/regulation/90 (the official version)
Page: https://openlegislation.uk/human-medicines-amendments-relating-to-the-windsor-framework-regulations-2024/regulation-90
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.