Definition · Plain-language
Pharmacovigilance System Master File (PSMF)
A Pharmacovigilance System Master File (PSMF) is the document required under EU law that describes the pharmacovigilance system a marketing-authorisation holder uses for its medicines.
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What the PSMF describes
The Pharmacovigilance System Master File is a structured description of the system a marketing-authorisation holder uses to fulfil its pharmacovigilance obligations. It documents the organisational structure, the identity and contact details of the Qualified Person Responsible for Pharmacovigilance (QPPV), the sources of safety data, the computerised systems and databases used, the processes for activities such as case handling and signal management, the quality system, and any delegated or contracted activities. It is, in effect, the reference map of how a company monitors the safety of its medicines.
Why it is required
The PSMF is mandated by EU pharmacovigilance legislation and detailed in the Good Pharmacovigilance Practices (GVP) guidance. It supports regulatory oversight by giving competent authorities a single, authoritative reference describing the holder’s safety system, which is particularly important during pharmacovigilance inspections. By requiring the system to be documented and kept up to date, the PSMF helps ensure that responsibilities are clearly assigned and that the system actually in operation matches what has been described to regulators.
Maintenance and access
A PSMF is a living document: it must be maintained to reflect the current pharmacovigilance system, with changes tracked through a logbook, and held at the location where the holder’s main pharmacovigilance activities are performed or where the QPPV operates. It must be made available for inspection and provided to regulators on request within defined timeframes. The PSMF is descriptive infrastructure documentation; it is distinct from product-specific safety documents such as the risk management plan, which addresses an individual medicine’s risks.
Key facts
At a glance
- Definition: EU-required document describing a holder’s pharmacovigilance system.
- Stands for: Pharmacovigilance System Master File.
- Required by: EU pharmacovigilance legislation; detailed in GVP guidance.
- Key role described: Qualified Person Responsible for Pharmacovigilance (QPPV).
- Covers: Structure, processes, resources, quality system, computerised systems.
- Obligation: Kept current; available to regulators on request or at inspection.
Common misconceptions
What people often get wrong
Often heard: A PSMF is the same as a risk management plan.
Actually: A PSMF describes the overall pharmacovigilance system of the holder. A risk management plan addresses the safety profile and risk-minimisation of a specific medicine. They are different documents serving different purposes.
Often heard: A PSMF is written once and then left unchanged.
Actually: It must be kept up to date to reflect the current system, with changes recorded in a logbook, so it remains an accurate description for inspection.
Often heard: Every individual medicine needs its own separate PSMF.
Actually: A PSMF describes a pharmacovigilance system, which may cover one or more medicines under a holder. It is system-level, not necessarily product-level.
Going deeper
