Pharmacovigilance system master file

The Pharmacovigilance System Master File (PSMF) is a detailed description of PhV and safety procedures, which a company has to follow when handling a medicinal product.

PSMF allows the authorized pharmacovigilance officers  to make sure that the company PhV system is implemented in line with EEU regulatory requirements.

The structure/content of PSMF is regulated by EEU GVP Rules.

Aston Health offers the services of competent PhV specialists that will help you introduce changes to the structure/content of PSMF following the update of EEU GVP Rules on May 19, 2022.