Standard
Category lists following implementation of the Windsor Framework
Initial list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
Documents
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.