PSMF / QPPV

Pharmacovigilance System Master File / Qualified Person for Pharmacovigilance

The PSMF is the single authoritative description of how a marketing-authorisation holder actually runs pharmacovigilance: the organisational structure, the QPPV and their deputies, the safety database and its validation, written procedures, the quality system, sources of safety data, delegated activities and the contracts covering them, and performance indicators. It is a live document, not a submission artefact — it must reflect reality on the day an inspector opens it.

The QPPV is a named individual, resident and operating in the EU/EEA, personally accountable for the establishment and maintenance of the pharmacovigilance system. They must have continuous 24-hour availability, authority over the system, and sufficient oversight to be able to answer for it. Naming a QPPV who lacks real authority or visibility is a classic inspection finding.

Inspectors use the PSMF as the map for the whole inspection: they read what you claim the system is, then test whether it operates that way. The most common failures are drift (the PSMF describes an organisation or database that has since changed), an incomplete logbook of changes, and delegated activities that are not properly captured with their contracts and oversight.

• —The PSMF describes the pharmacovigilance system as it actually operates — structure, database, procedures, quality system, delegated activities.
• —The QPPV is a named individual, resident in the EU/EEA, with 24-hour availability and real authority over the system.
• —A change logbook is a required annex — undocumented drift is a finding in itself.
• —Delegated and outsourced activities must be captured with their contracts and oversight arrangements.
• —It is the inspector’s map: everything claimed in it will be tested against practice.

Directive 2001/83/EC Art. 104(3)(a) (QPPV) and Art. 104(3)(b) (PSMF); Commission Implementing Regulation (EU) No 520/2012 Arts. 2 and 5–7; EMA GVP Module I (Pharmacovigilance systems and their quality systems) and Module II (Pharmacovigilance System Master File).