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Contact info

Sandra den Breejen
T: +31 (0)71 524 40 00
E: mail@vigilex.com


Have you implemented the PSMF?

GVP guideline II: Pharmacovigilance System Master File (PSMF)

According to the above mentioned guideline, each Marketing Authorisation Holder (MAH) with products authorised in the EEA should implement their PSMF in July 2015 at the latest. Vigilex has supported small, medium and large companies with the development of their PSMF, together with a maintenance process/standard operating procedure and associated training.

Several of our clients have recently had their first regulatory inspection experience which has involved review of the PSMF. We are proud to announce that the PSMFs subject to such a regulatory inspection, passed with minor observations. We drew on these experiences to create an improved version of the PSMF template.

Based on our experiences, we have also conducted a few audits focussing on the PSMF as implemented by our clients in medium and big pharma. After such an audit we have been able to advise the client on the accuracy and completeness of their PSMF.  

More information on the PSMF template,  our training materials and  maintenance process can be obtained via mail@vigilex.com. Please contact us with your needs and we will be happy to discuss how we can best support you.