Brexit Pharmacovigilance in the UK

 

Post-Brexit regulatory changes transformed the United Kingdom into an independent pharmacovigilance ecosystem. The shift created separate legal obligations, standalone reporting systems, and UK-specific safety governance. Marketing Authorisation Holders (MAHs) now manage two different regulatory pathways, i.e, EU/EEA and UK, as distinct jurisdictions.





The UK framework remains science-aligned with the EU model, yet the processes, reporting tools, and legal requirements follow MHRA-defined rules.

This guide sets out the complete picture so that MAHs understand every requirement needed for compliance.

Read here: https://resource.ddregpharma.com/blogs/post-brexit-pharmacovigilance-in-uk/

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