Guidance on Pharmacovigilance Procedures

Guidance on Pharmacovigilance Procedures for Marketing Authorisation Holders (MAHs) in the UK

This document provides a comprehensive guide for Marketing Authorisation Holders (MAHs) on meeting pharmacovigilance requirements in the UK, with specific considerations for Great Britain and Northern Ireland.

Key Highlights

• General Approach to Pharmacovigilance
  • Emphasizes the MHRA's responsibility for pharmacovigilance in the UK.
  • Outlines distinct requirements for Great Britain and Northern Ireland, including alignment with the Windsor Framework.
• Pharmacovigilance Actions for MAHs
  • ICSR Submissions: Adherence to requirements for submitting Individual Case Safety Reports (ICSRs).
  • Signal Detection: Robust processes for monitoring and identifying safety signals.
  • Risk Management Plans (RMPs): Development and submission of RMPs to mitigate risks.
  • Periodic Safety Update Reports (PSURs): Regular reporting to maintain compliance.
  • Post-Authorization Safety Studies (PASS): Implementation and reporting on safety studies.
  • Post-Authorization Measures (PAMs): Compliance with additional measures as required.
• Major Safety Reviews and Referrals
  • Procedures for safety referrals, safety communications, and implementation of EU safety referrals for Northern Ireland.
• Unfettered Access Route Requirements
  • Guidance on pharmacovigilance data submissions for MAs granted through this route.
• Patient Safety and Current Product Information
  • Ensures high standards of pharmacovigilance to uphold patient safety.
  • Mandates regular updates to product information to reflect the latest safety data.
• New Resources
  • Includes links to updated guidance documents and webinars related to the Windsor Framework.

This document reinforces the MHRA’s commitment to ensuring that MAHs maintain rigorous pharmacovigilance practices, safeguard patient health, and comply with evolving regulatory requirements.

Source: https://www.gov.uk/government/publications/guidance-on-pharmacovigilance-procedures

Region: United Kingdom