The MHRA has issued a new guidance on the implementation of the Windsor Framework.
This new guidance introduces revised definitions of authorisation types, for new and already approved products. From January 2025 medicines will be classified in UK as: UKMA (UK) Category 1, UKMA (UK) Category 2, UKMA (GB) and UKMA (NI).
Following the implementation of these arrangements, pharmacovigilance requirements will remain broadly in line with current requirements. However, there will be aspects of pharmacovigilance which will be impacted depending on whether the product is Category 1 or 2.
If you require more information and would like to be prepared for the coming changes, contact us at: [email protected]
Have a look at the document to see the changes in detail: UK Windsor Framework new guidance
