PSMF - Deadlines and Background Information

In July 2012, the new pharmacovigilance legislation came into force. It represents the most comprehensive change in the legal pharmacovigilance framework for human medicinal products since the introduction of specific requirements for pharmacovigilance in 1995.

One of the new key requirements is the Pharmacovigilance System Master File (PSMF). Each marketing authorization holder must have available this detailed description of the established pharmacovigilance system by 21 July 2015 at the latest. For centrally authorized products the date is 02 July 2015. In addition, a summary of the PSMF [PSMF Summary] must be included in the marketing authorization documentation/dossiers of most medicinal products at the above mentioned dates [requirement of variations]. An exception exists for traditional and homeopathic registrations. In the course of certain regulatory activities [e.g. new application, renewal application, competent authority request], the requirement for the provision of the PSMF and PSMF summary may already exist before the above mentioned dates 21 July 2015 rsp. 02 July 2015.

The PSMF is a key document for the communication with competent authorities and is inter alia required for the preparation of PV audits. It documents the extent to which the marketing authorization holder fulfills its legal pharmacovigilance obligations. Also the QPPV may rely on the PSMF to compare the established PV system with the current legal requirements.

The PSMF requirements regarding form and contents are extensive and described in detail by the GVP module II. The PSMF is a company-specific document and combines information from different departments. Accordingly, a considerable time requirement should be taken into account for its preparation.

In the past months, we have prepared PSMFs for a variety of clients and gladly offer our respective expertise to you and your company. We are available for you if you want to define and fulfill your obligations regarding the PSMF [definition of the need for action, preparation of PSMF, PSMF Summary, support for relevant Variations, etc.].

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