Helping companies around the world navigate the regulatory maze

Pharmacovigilance System Master Files

In July 2012 the requirement for a Pharmacovigilance System Master File (PSMF) was introduced into European Good Pharmacovigilance Practices. By July 2015 all Marketing Authorisation Holders have to have implemented their PSMF. Additionally, any company planning to submit a marketing authorisation application has to have a PSMF in place by the date they submit their application, supporting a pharmacovigilance system that needs to be operational during the application approval process.

PSMFs have become critical to the success of regulatory agency inspections and internal audit programmes, and are pivotal documents for pharmacovigilance systems.

Mapi’s pharmacovigilance team has a wealth of experience in guiding companies through the intricacies of setting up a PSMF, offering flexible suggestions to meet individual needs. We can support companies in the following ways:

  • Development and preparation of an initial PSMF;
  • Regular maintenance activities to ensure the PSMF is continuously up-to-date;
  • Review of PSMF to identify possible gaps in the pharmacovigilance system;
  • Review of PSMF to ensure its compliance with regulatory requirements.

To view Mapi's Pharmacovigilance System Master Files Webinar, click here

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