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Pharmacovigilance System Master File (PSMF)
A MANDATORY EEA DOCUMENT ALWAYS UP TO DATE
The Pharmacovigilance System Master File (PSMF) is a crucial and mandatory document for pharmacovigilance compliance in the European Economic Area (EEA). It is required by EU Directive 2010/84/EU and contains comprehensive information about the pharmacovigilance system in place for Marketing Authorization Applications (MAAs) and Holders (MAHs).
The PSMF must be kept up to date and readily available for inspection. Therefore effective day-to-day management, continuous updates, and expertise in handling PSMFs are critical for any pharmacovigilance system.
Key elements of the PSMF structure include:
- QPPV
- Organization and structure of the
- Marketing Authorization Applicant (MAA) or Holder (MAH)
- Pharmacovigilance Standard Operating Procedures (SOPs) and processes
- Drug Safety Data
- Electronic systems and Drug Safety Databases
- Quality Management and Control systems
INSPECTION-READY LOCAL AND GLOBAL PSMFs
RPN assists in creating a stand-alone local PSMF or annexes to a global PSMF that meet all the local authority requirements while maintaining a robust, centralized pharmacovigilance system.
We also support in maintaining core and local PSMFs, ensuring that the pharmacovigilance system remains fully compliant with EU and international regulations and guidelines, and is inspection-ready at all times.