PSMF Development & Maintenance

A Pharmacovigilance System Master File (PSMF) summarizes your pharmacovigilance (PV) system and is a critical document for any Marketing Authorization Holder. To comply with EU PV legislation requirements, all MAHs and MAH applicants in the EU must develop and maintain a PSMF for their PV system. Beyond the EU, more and more requirements for other local/regional PSMFs arise (e.g., UK, France, Eurasian Union).

Biomapas has extensive experience building and managing a PSMF that accurately and comprehensively describes your company’s PV system according to the applicable legislation. They also help you reduce the burden of maintenance, especially when more PSMFs than the “basic” EU version are required.

Your PMSF is eminent during the authorization phase as evidence of having an adequate PV system in place, it is a prerequisite for Marketing Authorization Approval. Post-authorization, the PSMF is usually the starting point for regulators during inspections as it provides essential insights into your compliance regarding pharmacovigilance requirements. Biomapas’ specialists understand its complexity and follow all regulatory guidelines and Good Pharmacovigilance Practice (GVP) and other applicable local/regional legislation when developing and maintaining your PSMF.