Pharmacovigilance System Master File (PSMF) Development and Maintenance

Postmarketing Expertise for Pharmacovigilance Systems

The Pharmacovigilance System Master File is designed to summarize the pharmacovigilance (PV) system of the Marketing Authorization Holder (MAH) and is business critical. To be compliant with EU PV legislation requirements, all companies with applicant/MAH status in the EU must develop and maintain a PSMF for their product(s).

We work with established documentation systems to create and maintain a PSMF that accurately and comprehensively describes your company’s PV system in line with the legislative format. A comprehensive PSMF is paramount as it is a document shared with EU regulatory inspectors and provides an important first insight into your company’s PV system.

PSMF Guidelines, Processes, and Maintenance

It is essential to monitor and centrally document in the PSMF all aspects of the PV system in accordance with company procedures and regulatory requirements. The PSMF is part of the registration dossier and must be prepared within the required timelines for the Marketing Authorization Application (MAA). It is signed off by the EU Qualified Person for Pharmacovigilance (EU QPPV).

Our experts understand the complexity of the PSMF and follow the regulatory guidelines on Good Pharmacovigilance Practice (GVP) specific to each PV system.

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