MHRA Guidance: QPPV and PSMF Guidelines for UK Market Authorisations

Navigating New Horizons: MHRA's Updated QPPV and PSMF Guidelines for UK Market Authorisations

The MHRA's November 2023 pharmacovigilance guidance mandates UK marketing authorisation holders to have a qualified person responsible for pharmacovigilance (QPPV) and to maintain a pharmacovigilance system master file (PSMF), accessible electronically within the UK.

To ensure the QPPV's qualifications meet regulatory standards, Companies should establish a national contact for pharmacovigilance in the UK, and understand the detailed requirements for the PSMF's content and accessibility.

This guidance solidifies the UK's commitment to patient safety and regulatory harmonisation post-Brexit, impacting marketing authorisation holders by requiring a more stringent approach to their pharmacovigilance oversight.

As a result, Companies impacted by this should review and update their pharmacovigilance systems and documentation to comply with the MHRA's guidelines, in order to ensure their QPPV and PSMF meet the specified criteria.

For further assistance in aligning with these new requirements, or for any pharmacovigilance-related inquiries, please contact PharSafer’s experts today – where we are ready to support you in navigating these updates and ensure enhanced levels of compliance.

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