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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.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 20 December 2024
• Last updated: 11 February 2025 — See all updates

Documents

Category lists of products

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Category 1 list of products (authorised up to 31 December 2024)

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Details

The Windsor Framework changes the regulation of medicinal products that were formerly in the scope of the EU centralised procedure so that these products can be licensed UK-wide under UK law.

Products not within this scope will be 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 will be assigned to Category 1 or Category 2.

Published 20 December 2024
Last updated 11 February 2025 + show all updates

1. 11 February 2025

   Updated the Category 1 list to include authorisations granted in December 2024.

2. 20 December 2024

   First published.