Pharmacovigilance System Master File (PSMF)
Pharmacovigilance
The Pharmacovigilance System Master File (PSMF) is a key regulatory document required under EU legislation. It describes the PV system used by a MAH for one or more authorized products.
Regulatory authorities may request the PSMF at any time, and MAHs must provide it within 7 calendar days. PVpharm ensures your PSMF is always compliant, inspection-ready, and accurately reflects your organization’s pharmacovigilance system.
PVpharm provides comprehensive PSMF services, including:
- PSMF creation: drafting of a fully compliant PSMF, tailored to your pharmacovigilance system
- PSMF maintenance: Ongoing maintenance and regular updates to reflect changes in structure, processes, QPPV responsibilities, or global safety operations
- Support on PSMF-related Regulatory Inspections: support during inspections and ensuring your PSMF is always audit-ready.
- Support for non-EU companies: compliant EU-based PSMF for their European operations
