SOP: Pharmacovigilance System Master File (PSMF)

The Pharmacovigilance System Master File (PSMF) is a mandatory document for pharmaceutical companies holding or applying for a Marketing Authorisation in the European Union. The PSMF describes the pharmacovigilance system used to monitor the safety of medicinal products and must be available for inspection by regulatory authorities.
 
 
This template provides a structured framework aligned with EU Good Pharmacovigilance Practice (GVP) Module II, supporting companies in establishing a compliant pharmacovigilance system.
The template includes the required sections describing key pharmacovigilance elements such as:
EU QPPV roles and responsibilities
Organizational structure and PV governance
Sources of safety data
Pharmacovigilance processes and procedures
Computerized systems and databases
PV system performance monitoring
Pharmacovigilance quality system
Annexes covering organizational structure, safety data sources, and PV processes
 
Guidance text is included to support efficient customization and implementation.
The template is particularly useful for pharmaceutical and biotech companies preparing for EU marketing authorization, as well as companies establishing or updating their pharmacovigilance system.
Using a structured template significantly reduces the time required to develop a compliant PSMF while ensuring alignment with EU regulatory expectations.
 
Typical use cases
Preparing for EU Marketing Authorisation Application (MAA)
Establishing a new pharmacovigilance system
Updating an existing PSMF to align with EU GVP requirements
Supporting PV inspections and regulatory readiness
 
Document format
Editable template provided in Word format, allowing easy customization to fit the organization’s pharmacovigilance system.