A Pharmacovigilance System Master File is a document describing the pharmacovigilance system used by the marketing authorisation holder (MAH) with respect to one or more authorized medicinal products.
Pharmacovigilance System Master File
The Pharmacovigilance System Master File describes the MAH’s pharmacovigilance system and documents the compliance with the legal requirements in the EU/EEA. The PSMF provides a detailed description of all pharmacovigilance activities performed by the MAH in order to ensure safety of its products. The PSMF may be requested and assessed by any national competent authorities or by the Agency (EMA), during marketing authorisation application(s) or post-authorisation.
Pharmacovigilance System Master File in the European Union
The content of the pharmacovigilance system master file should reflect global availability of safety information for medicinal products authorised in the EU, with information on the pharmacovigilance system from both locally and regionally activities.
The Applicant/Marketing Authorisation Holder is responsible for establishing the Pharmacovigilance System Master File and for registering the master file location with the competent authorities in the marketing authorisation application and in the XEVMPD.