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

Products not within this scope willare 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 willindicating betheir assigned to Category 1 or Category 2.category.