GovWire

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 MHRAs 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 MHRAs existing guidance on pharmacovigilance procedures.