Summary

The Pharmacovigilance System Master File (PSMF) is a legal requirement in the European Union (EU). A PSMF shall describe the pharmacovigilance (PV) system for one or more medicinal products of a marketing authorization holder (MAH) and support/document its compliance thus managing and improving the PV system.

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Pharmacovigilance Nugget #3 The Challenges of Effective PSMF Maintenance - December 2018