An Overview Of The PSMF: Pharmacovigilance System Master File

By David Lough, Senior PV Consultant; and Thomas Chatzopoulos, Vice President, QPPV Office

The EU Pharmacovigilance System Master File (PSMF) is a mandatory document that must be created and maintained by the Marketing Authorisation Holder (MAH) for each medicinal product. This comprehensive document serves as a detailed account of the MAH’s pharmacovigilance system, outlining how the company monitors, assesses, and manages the safety of its products.

The PSMF is crucial for demonstrating the MAH's adherence to European Union pharmacovigilance regulations and guidelines. It provides a structured overview of the systems and processes in place to ensure that safety data is accurately collected, evaluated, and reported in compliance with EU standards. Each PSMF should pertain to a single pharmacovigilance system, although an MAH may possess multiple PSMFs if it operates several distinct systems. Conversely, multiple MAHs can share a single PSMF if they collaborate on a common pharmacovigilance framework.

By maintaining a PSMF, the MAH ensures that it has a clear, organized record of its pharmacovigilance practices, which facilitates regulatory inspections and supports ongoing compliance with EU safety requirements. This document is an essential component of the pharmacovigilance infrastructure, playing a key role in safeguarding patient health and upholding regulatory standards across the European market.