Brexit: Pharmacovigilance Requirements for UK MAHs

Recommendation

15/16 November 2023

Serialization/Aggregation - Live Online Training
Requirements, Challenges & Solutions

Following the Brexit, the MHRA posted an updated guidance to become familiar with the pharmacovigilance requirements for UK marketing authorization holders (MAHs).

MHRA´s guidance on UK pharmacovigilance requirements  

In the blog post, the agency provides sources of guidance and further information, including the following:

• In general, the EU Good Pharmacovigilance Practices (GVP, EudraLex Volume 9) continues to apply in the UK.
• There are some exceptions and modifications to the EU GVP that apply to UK MAHs and the MHRA.
• Guidance on the submission of the summary of pharmacovigilance system details and on the UK QPPV and the pharmacovigilance system master file (PSMF).
• Guidance on Pharmacovigilance procedures (e.g. submission of adverse drug reactions reports and PSURs).
• Frequently asked questions (available by contacting the respective pharmaceutical trade association via Email).

For more information please read the post Guidance on pharmacovigilance requirements for UK authorized products from 1 January 2021 on the MHRA blog.