Change of https://www.gov.uk/government/publications/category-lists-following-implementation-of-the-windsor-framework

Change description : 2026-03-02 13:40:00: Updated to add new Category 1 & 2 lists for products. [Guidance and regulationBrexit]

Showing diff : 2025-08-07 22:48:35.574926176 +00:00..2026-03-02 13:41:13.249166938 +00:00

Standard

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.

Documents

Category 1 list of products

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Category 2 list of products

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Details

The 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

Published 20 December 2024
Last updated 42 AugustMarch 20252026 + show all updates
  1. Published updated 'Category 1 list of products' & 'Category 2 list of products'. These lists replace any previously published lists.

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Update history

2026-03-02 13:40
Updated to add new Category 1 & 2 lists for products.

2025-08-04 17:11
Published updated ‘Category 1 list of products’ & ‘Category 2 list of products’.These lists replace any previously published lists.

2025-03-25 09:36
Updated category 1 and 2 lists with minor corrections

2025-03-18 16:20
Updated list of Category 1 products.Category 2 list added.

2025-02-11 09:30
Updated the Category 1 list to include authorisations granted in December 2024.

2024-12-20 15:36
First published.