Pharmacovigilance System Master File

What is a PSMF?

The Pharmacovigilance System Master File (PSMF) is a legal requirement for any medicinal product authorised in the European Union (EU). The PSMF provides a detailed description of the entire pharmacovigilance system for the organisation and documents the performance and compliance with the requirements as described by Good Pharmacovigilance Practices (GVP).

GVP Module II

The structure and content of the PSMF are defined in GVP Module II. It reflects the global collection, handling, assessment, storage and reporting of safety information for EU authorised medicinal products, presenting information on the pharmacovigilance system applied at global, regional and local levels. 

At QVigilance, we follow GVP Module II’s recommendation for a modular based PSMF arranged as follows:

  • Section I Qualified person responsible for pharmacovigilance (QPPV)
  • Section II Organisational structure of the marketing authorisation holder
  • Section III Sources of safety data
  • Section IV Computerised systems and databases
  • Section V Pharmacovigilance processes
  • Section VI Pharmacovigilance system performance
  • Section VII Quality system


Additionally, there are a number of annexes (Annexes A to I) maintained as living documents to provide supplementary information. The PSMF must be maintained on an on-going basis and must be made available to National Competent Authorities on request at any time during marketing authorisation application(s) or following authorisation.

QVigilance can provide author, review or provide support in preparing a PSMF in preparation for product application/authorisation in the EU. If a PSMF is already in place, QVigilance can provide support in of the PSMF, including review and update as required.

Need Support with your PMFS?

Speak with our experts

Submit an RFI