The Pharmacovigilance System Master File (PSMF)

The PSMF is a structured description of the pharmacovigilance system a Marketing Authorisation Holder (MAH) uses to meet its obligations. It is the reference an inspector reads first: it should let any competent reader understand, end to end, how your organisation detects, processes, assesses, and reports safety information.

• It is a living description of people, processes, and systems — the QPPV, the SOPs, the databases, the staffing, and the history of how the system has been run.
• It is not a one-off document written at authorisation and filed away. An out-of-date PSMF is itself a finding.
• It is not a copy of the legislation. It describes your system specifically, not pharmacovigilance in general.

Regulation (EU) 2019/6, in force since 28 January 2022, requires every MAH to operate a pharmacovigilance system and to document it in a PSMF. Commission Implementing Regulation (EU) 2021/1281 then lays down the detailed rules on good veterinary pharmacovigilance practice (VGVP) and on the format and content of the PSMF itself.

• The PSMF replaced the former Detailed Description of the Pharmacovigilance System (DDPS).
• One PSMF is maintained per QPPV — it covers all products that QPPV is responsible for, not a separate file per product.
• It must be located within the EU and made available to competent authorities on request.

The body of the PSMF describes the system; the annexes carry the evidence. A typical veterinary PSMF includes the following components.

Main body

• QPPV details — identity, contact information, and a summary of responsibilities.
• Organisational structure — the MAH, reporting lines, and any delegated or outsourced activities.
• Sources of safety data — how adverse events are collected from veterinarians, users, distributors, literature, and authorities.
• Computerised systems and databases — what is used for case management, where data resides, and validation status.
• Processes — case handling, signal management, benefit-risk evaluation, and reporting.
• Quality system — SOPs, training, audits, and how deviations are managed.

Annexes

• List of SOPs and key documents.
• Description and validation status of computerised systems.
• Lists of contracts and agreements covering delegated PV activities.
• The audit schedule and log of completed audits and CAPAs.
• A logbook of changes to the PSMF itself.

The Qualified Person for Pharmacovigilance is the accountable centre of the system, and the PSMF must make that accountability legible.

• The QPPV must reside and operate within the EU/EEA and be accessible to competent authorities at all times.
• There is one QPPV per PSMF, with a deputy named to provide cover during absences.
• The QPPV is responsible for PSMF maintenance, oversight of case processing and signal management, and for regulatory responses.
• Curriculum vitae and a clear statement of authority and resources support the appointment.

The difference between a compliant PSMF and a risky one is rarely the initial draft — it is whether it stays current. A few habits keep it inspection-ready.

• Version control — every change dated, attributed, and recorded in the change logbook.
• Living annexes — SOP lists, contracts, and the audit log updated as reality changes, not annually in a rush.
• Traceability — the PSMF should match what actually happens; an inspector will test the description against records.
• Readiness — the file producible on request, with the QPPV able to walk through it confidently.

The recurring findings in PV inspections are usually about currency and consistency, not the absence of a document.

• A PSMF that no longer reflects the current system — outdated SOP lists, superseded systems, or stale staffing.
• Annexes that contradict the main body, or contracts for delegated activities that are missing or expired.
• No clear change history, so the evolution of the system cannot be reconstructed.
• Gaps between the described process and the actual records — for example, a stated timeline the case files do not support.