Category lists following implementation of the Windsor Framework
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
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Details
皇冠体育app Windsor Framework changed the regulation of medicinal products that were formerly in the scope of the EU centralised procedure so that these products are now licensed UK-wide under UK law.
Products not within this scope are authorised UK-wide under UK and applicable EU law (as amended by Regulation (EU) 2023/1182 and Directive (EU) 2022/642), as has been the case since 1 January 2021.
To be clear which rules apply for UK authorisations, all new marketing authorisation (MA) applications and existing authorised products indicating their category.
Updates to this page
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Updated category 1 and 2 lists with minor corrections
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Updated list of Category 1 products. Category 2 list added.
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Updated the Category 1 list to include authorisations granted in December 2024.
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First published.