A Pharmacovigilance System Master File (PSMF) is a comprehensive document containing the detailed description of a Marketing Authorization Holders’ (MAH’s) pharmacovigilance (PV) system ensuring the safety of their products. An MAH, who holds market authorizations (MAs) for one or more medicinal products within the European Economic Area (EEA) is required to have a PSMF as per the EU Directive 2010/84/EU (amending 2001/83/EC).

The content of any PSMF should clearly display global availability of the safety information for medicinal products authorized in the EU. The structure of the PSMF should adhere to the guidance of Good Pharmacovigilance Practices (GVP), Module II, with specified sections with details of the PV system.

The applicant/MAH is responsible for:

  • establishing PSMF 
  • registering the master file location with the competent authorities in MA application and Xtended Medicinal Product Dictionary (XEVMPD)

The annexes in the PSMF are expected to be kept up-to-date all the time, as it forms the basis of pharmacovigilance. PSMF is also considered as a reference document for drug safety operations, as it plays a vital role and requires expert knowledge to meet all the regulator’s requirements.

A PSMF is required to be in place at the time of submission of all the new applications. Any competent authority or European Medical Agency (EMA) may request for PSMF and may ask for its assessment during marketing or post-marketing authorizations. However, within 7 days of request, a PSMF must be made available.

How are you placed to track all your PV activities and compile it as a PSMF? Are you willing to update your PSMF? Contact our safety and pharmacovigilance experts to know more. Reach us at sales@freyrsolutions.com.