# Category lists following implementation of the Windsor Framework

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/ab5c7f59-f15d-493e-bdf6-0aa073db90ec
Type: Standard
Published: December 20, 2024
Updated: March 2, 2026

> This guidance document clarifies significant changes to the regulatory landscape for medicinal products in the United Kingdom following the implementation of the Windsor Framework. The primary shift involves products that were historically governed by the European Union’s centralized procedure. Under the new framework, these medicines are now licensed across all of the UK exclusively under national UK law. Conversely, medicinal products falling outside this specific scope continue to be authorized UK-wide under a blend of UK law and relevant EU regulations, including Regulation (EU) 2023/1182 and Directive (EU) 2022/642, a practice consistent with the protocols established on January 1, 2021. While this text represents a general regulatory update rather than an enforcement action against a specific company, it applies to all pharmaceutical manufacturers operating within the UK market. There are no violations or inspection dates cited; instead, the document focuses on compliance with the updated legal framework. To ensure administrative transparency and regulatory certainty, the MHRA mandates that all holders of marketing authorizations—and those submitting new applications—must clearly indicate the specific category of their products. This categorization is essential for identifying which legal standards apply to each authorization, ensuring that both new and existing medicinal products remain compliant with the evolving jurisdictional requirements of the Windsor Framework.

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## Content

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.

## Attachments

- [Category 2 list of products](https://assets.publishing.service.gov.uk/media/69a591d5238e02a088ce17f9/All_PL_listing_Category_2_For_publication__220226.xlsx)
- [Category lists of products](/government/publications/category-lists-following-implementation-of-the-windsor-framework/category-lists-of-products)
- [Category 1 list of products](https://assets.publishing.service.gov.uk/media/69a591b9a56a5482312c7176/All_PL_listing_Category_1_For_publication__220226__2_.xlsx)