Pharmacovigilance following agreement of the Windsor Framework
Information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework.
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This guidance is designed to provide information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework.
These changes will be implemented from 1 January 2025.
This guidance should be used in conjunction with the MHRA’s guidance on the Windsor Framework including UK-wide licensing for human medicines, and labelling and packaging guidance.
This guidance should also be used to supplement the operational guidance in the MHRA’s existing guidance on pharmacovigilance procedures.
Updates to this page
Last updated
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Updated to remove: “1. Subject to the UK providing written guarantees to the European Commission as provided for in Article 8 of EU Regulation 2023/1182 and following the entry into force and application procedure provided for in Article 14” from document Pharmacovigilance following agreement of the Windsor Framework.
Update history
2026-02-09 17:06
Updated section 3 with wording on CIR 520/2012 and link to further information
2025-03-11 09:54
Updated to remove: “1. Subject to the UK providing written guarantees to the European Commission as provided for in Article 8 of EU Regulation 2023/1182 and following the entry into force and application procedure provided for in Article 14” from document Pharmacovigilance following agreement of the Windsor Framework.
2024-08-30 10:29
First published.