Usage Examples
- The inspector asked for the PSMF logbook before anything else.
- We cannot register the PSMF location in Article 57 until the QPPV contract is signed.
- Annex G of the PSMF still lists two audit findings with no agreed CAPA.
What is Pharmacovigilance System Master File (PSMF)?
Pharmacovigilance System Master File (PSMF) is the detailed description of the pharmacovigilance system a marketing authorisation holder operates for EU-authorised medicines, kept at one registered EU site and produced to competent authorities within seven days of request.
The Pharmacovigilance System Master File exists because a regulator supervising a marketing authorisation holder cannot observe a pharmacovigilance system directly. It can only read the account the holder keeps. EU law therefore requires one standing file recording who the QPPV is, where safety data comes from, and how the system actually performs, so that supervision, inspection planning and risk-based inspection targeting all start from the same documented picture.
The PSMF covers the system, not the product. It describes the QPPV, the organisational structure, the sources of safety data, computerised systems and databases, written procedures, system performance and the quality system, and it must contain at least the documents listed in Article 2 of Implementing Regulation (EU) No 520/2012. Product-level benefit-risk conclusions sit in periodic safety reports and risk management plans instead.
The PSMF is operated as a controlled living document, not a submission. Its location and the QPPV's contact details are registered in the Article 57 database, every content change is captured in a logbook with date, owner and nature of change, and the file must be permanently available for inspection at its stated site whether the inspection is announced or unannounced.
Not to be confused with
- Summary of the pharmacovigilance system
- the short set of elements filed in module 1.8.1 of a marketing authorisation application, one of which is a reference to where the PSMF is kept. The summary goes in the dossier; the PSMF stays at its registered site and is not routinely requested pre-authorisation.
- PSUR
- a PSUR presents the benefit-risk of a product over a defined period. The PSMF describes the system that produces PSURs and tracks their submission timeliness as a performance indicator. System versus product.
- QPPV
- a person, not a file. A single QPPV is appointed to establish and maintain the system the PSMF describes, and must have permanent access to the file.
- Article 57 database entry
- holds the registered PSMF location and QPPV contact details and must be corrected within 30 calendar days of a change. The entry points at the PSMF; it never contains it.
The minimum content sits in Implementing Regulation (EU) No 520/2012; GVP Module II (Rev 2, in effect 31 March 2017) explains how to meet it.
What you must do
- 1Locate the PSMF within the EU, at either the site where the main pharmacovigilance activities are performed or the site where the QPPV operatesIR Art 7(1)
- 2Include at minimum every document listed in the implementing regulation's content article, covering QPPV, organisational structure, safety data sources, computerised systems, processes, performance and quality systemIR Art 2
- 3Register the PSMF location and QPPV details in the Article 57 database and update them immediately and no later than 30 calendar days after any changeIR Art 4(4)
- 4Submit a copy to a national competent authority or the Agency no later than seven days after receipt of the requestDIR Art 23(4)
- 5Maintain a logbook capturing at least the date, the person responsible and the nature of each documented changeIR Art 5(4)
Common mistakes
Letting the Article 57 entry drift after a QPPV or site change
the database must be corrected immediately and within 30 calendar days. A stale entry misdirects inspectors to the wrong location and breaks the continuous supervision the registration exists to enable.
Assembling the PSMF when the inspection is announced
the file must be permanently available for inspection at its stated location, announced or unannounced, and permanently accessible to the QPPV. A file built on request is evidence that the system it claims to describe was not being maintained.
Removing the audit note before the CAPA is closed
where an audit raises major or critical findings, the PSMF must carry a note describing the corrective and preventative action, the date the finding was identified and the anticipated resolution date. The note stays until the action is implemented or independently verified, and the annex must list completed audits over a rolling five-year period.
When This Matters
- The inspector asked for the PSMF logbook before anything else.
- We cannot register the PSMF location in Article 57 until the QPPV contract is signed.
- Annex G of the PSMF still lists two audit findings with no agreed CAPA.
Frequently Asked Questions
The PSMF must be kept at a site inside the EU, either where the marketing authorisation holder's main pharmacovigilance activities are performed or where the QPPV operates. Under EEA agreements it may also sit in Norway, Iceland or Liechtenstein. The registered location is a physical office address, even when the file is electronic.
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