The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK medicines regulator. Its pharmacovigilance procedure guidance is the main operational starting point for UK post-authorisation pharmacovigilance.
Core official resources
- Guidance on pharmacovigilance procedures — covers ICSRs, signal detection, RMPs, PSURs, PASS, referrals, safety reviews and communications.
- Good pharmacovigilance practice (GPvP) — explains the UK GPvP inspection framework and compliance expectations.
- Good pharmacovigilance practice for medicines collection — consolidates MHRA GPvP guidance and related materials.
- Yellow Card — UK reporting service for suspected adverse reactions and safety incidents.
Practical use
Use this page as the QPPV.com entry point when checking current UK-specific pharmacovigilance procedures. The MHRA guidance is maintained separately from EU GVP and should be checked for UK-specific modifications and procedural differences.