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UK Regulator Explains Changes To Pharmacovigilance Rules From 2025

 
• By Eliza Slawther

While pharmacovigilance requirements for medicines in the UK will remain “broadly in line” with current rules from 1 January 2025, companies should be aware of changes for some products after this date, the UK’s MHRA says.

Pharmacovigilance
• Source: Shutterstock

New guidance from the UK Medicines and Healthcare products Regulatory Agency sets out how pharmacovigilance requirements will change from 1 January 2025, when the post-Brexit “Windsor Framework” for easing the movement of goods between Great Britain and Northern Ireland comes into effect.

Key Takeaways

  • From January 2025, the UK’s MHRA will be able to issue marketing authorizations to drugs for use across the UK, not just in Great Britain.

From this date, the MHRA will authorize all new medicines for the whole of the UK (England, Northern Ireland, Scotland...

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