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 requirementes 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.