Description of the Pharmacovigilance System in the PV System Master File (PSMF)

EU Directive 2001/83/EC requires that every Marketing Authorisation Application should include a summary of the Pharmacovigilance System Master File being employed by the pharmaceutical company that filed the application. This summary is intended to provide proof that there is a Qualified Person for Pharmacovigilance at his disposal and that this QPPV is available. For applications submitted after 2 July 2012, a Risk Management Plan should also be submitted. Finally, the PSMF is intended to provide the competent authorities with proof that the applicant as a (future) Marketing Authorisation Holder is capable to deal with adverse events properly, including collecting and notifying the competent authorities.

We can assist you in building a pharmacovigilance system, as well as in improving an existing pharmacovigilance system.

We will discuss the various topics that have to be addressed in the PSMF according to Module 2 of the Good Pharmacovigilance Practices with you and implement this information into a readily available PSMF template. For clients that wish to outsource all or the majority of their pharmacovigilance activities to DADA, tailor-made amendments to the existing DADA pharmacovigilance system will be implemented into a client-specific Pharmacovigilance System Master File, per the requirements in the new pharmacovigilance legislation. We will provide your Regulatory Affairs staff with a summary of the PSMF for inclusion in the marketing authorisation application and prepare the PSMF to be ready for submission to competent authorities, as needed.

Through the production and maintenance of the PSMF, the marketing authorisation holder and the QPPV should be able to:

  • gain assurance that a pharmacovigilance system has been implemented in accordance with the requirements;
  • confirm aspects of compliance in relation to the system;
  • obtain information about deficiencies in the system, or non-compliance with the requirements;
  • obtain information about risks or actual failure in the conduct of specific aspects of pharmacovigilance.