Pharmacovigilance System Master File (PSMF)

Preparation and maintenance of comprehensive documentation on pharmacovigilance systems for all marketed products.

PSMF is a legal requirement in the UK, EU and many other countries across the world and is applicable to any authorized medicinal product approved in the territory. MAHs need to maintain and have the readiness to submit a summary of information on pharmacovigilance systems to the competent authorities.

PSMF Process

A robust, risk-proportionate process is in place with standard operating procedure-defined templates and checklists to ensure data accuracy and completeness in line with applicable regulatory requirements.

Our process also helps in linking different systems and analyzing the corresponding impact on the PSMF with the support of a closely knit and a well cross-referenced linkage system document. This ensures full coverage of the pharmacovigilance system while the PSMF is prepared.

APCER has a dedicated PSMF team that works under close supervision of the respective QPPVs. The team consists of highly trained individuals with multiple years of PSMF management experience for the EU, UK, and ROW.

PSMF/National PSMF for Rest of World (RoW)

Recently, many RoW countries such as Gulf Cooperation Council (GCC) nations (Arab countries) and Eurasian Economic Union (EAEU) countries have started requesting PSMF/National PSMF.

National PSMF/National pharmacovigilance sub-system file (PSSF/PvSF) shall describe the key elements of pharmacovigilance activities at the national level in the local country concerned. The national PSSF shall be maintained in a current state and be permanently available to the local QPPV.

Some examples of local PSMF requirements:

  • GCC nations (Arab nations): Country-wise national PSSF/PvSF
  • India: Pharmacovigilance System Master File (PvMF)
  • EAEU countries: PSMF

APCER’s global PSMF solutions include:

  • establishment and maintenance of the PSMF,
  • setting up of the PSMF procedures,
  • third-party expert PSMF review and gap analysis,
  • template transfer of existing PSMF,
  • revision of PSMF in a timely manner to reflect significant changes in the pharmacovigilance system, and
  • maintenance of the core EU-PSMF and local PSMF(s).

How can we work together for better health?

How can we work together for better health?

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