What Are PSMF and PSSF?

The Pharmacovigilance System Master File (PSMF) is a key regulatory document providing a comprehensive overview of a company’s pharmacovigilance (PV) system. It is required by EU GVP Module II for all Marketing Authorization Holders (MAHs) in the European Union, covering both centrally and decentrally authorized products.

When expanding beyond the EU, additional requirements may apply. Companies that already maintain a PSMF under EU legislation may also need to prepare a Pharmacovigilance Sub System File (PSSF) - or a local equivalent - if they hold a marketing authorization in non-EU countries that mandate local PV documentation.

These requirements vary by region and should be carefully considered as part of your global PV compliance strategy.

PSMF & PSSF

Why Are PSMF and PSSF So Important for Compliance?

A well-maintained PSMF is more than a formality - it is a cornerstone of your PV compliance and a central focus during inspections and audits.

As required by EU GVP Module II, the PSMF must be:

• Continuously updated to reflect the current state of the PV system

• Submitted within 7 calendar days upon request from competent authorities

• Provided as a summary at the time of Marketing Authorization Application (MAA)

These obligations are further supported by Commission Implementing Regulation (EU) No 520/2012, which outlines specific expectations regarding the structure, maintenance, and accessibility of the PSMF as a central tool for pharmacovigilance oversight and patient safety.

For non-EU markets, a PSSF or local PSMF ensures national regulatory compliance and supports smooth interactions with local authorities.

Ensure Compliance & Inspection Readiness