Category lists of products
Updated 25 March 2025
© Crown copyright 2025
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/category-lists-following-implementation-of-the-windsor-framework/category-lists-of-products
1. Overview
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 will be assigned to Category 1 or Category 2. On this page the MHRA will publish lists of products indicating their category.
The rules for assigning the product category were published on 30 August 2024 in the MHRA UK-wide licensing guidance.
The following authorisations will not be categorised:
-
Northern Ireland-only MAs
-
traditional herbal registrations
-
homeopathic registrations through the simplified scheme
-
unlicensed medicines (including medicines supplied through the early access to medicines scheme)
-
parallel imports
-
investigational medicinal products
2. How Category 1 and Category 2 lists will work
In the case of products with more than one active substance or product name, there will be multiple rows in the list for that product corresponding to each of the active substances.
The category has been assigned based on the criteria set out in section 4 of the UK-wide licensing guidance. To assist MA holders in verifying the category of each of their products, the MHRA has provided a decision ladder.
3. Category 1 list
The Category 1 list is a list of products with an authorisation in effect on 31 December 2024 that have been assigned to Category 1.
Any products that were authorised on 31 December 2024 but have been cancelled since then will not appear in the updated list.
4. Category 2 list
The Category 2 list is a list of currently authorised products that had an authorisation in effect on 31 December 2024 which have been assigned to Category 2.
Any authorisations that were authorised on 31 December 2024 but have been cancelled since then will not appear in the updated list.
5. Categorisation from 1 January 2025
From 1 January 2025, the MHRA will update the lists on a quarterly basis .
The product categorisation of new MAs will also be included in the lists of new marketing authorisations that are published every two weeks. When submitting MA applications via the Human Medicines portal, applicants must assign a category where applicable. Refer to the UK-wide licencing guidance and additional portal guidance. The MHRA will assess the categorisation and correct it if necessary during the procedure. Incorrect categorisation will not lead to invalidation of your application. The final agreed category will be included in the grant letter.
6. Contact
If you have a specific query about the categorisation of a medicinal product, you can submit your query to RIS.NA@mhra.gov.uk, with the email header ‘LICENCE CATEGORY’.