UK – Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA

Exceptions and modifications document – updates (01 Jan 2025)

-Overall updates were made to the document to reflect changes to UK legislation implementing new arrangements for medicines following the Windsor Framework and European Union Updates to GVP Module XVI and Addendum II

– Updates throughout to indicate requirements for Category 1 and Category 2 products following the implementation of the Windsor Framework

– Other specific updates include: Section I.C.1.4 – Additional information added for Category 1 products with an associated EU license to consider new information published on the European Medicines web portal and where necessary make changes to the UK authorisation via a variation…