The PSMF is a modular document containing all of the details of the pharmacovigilance system for the product. It must be made available to a Competent Authority on request, within 7 calendar days.
A PSMF is required to be in place for all marketing authorisation holders who hold Marketing Authorisations (MA) within the EEA. It is required to be in place at the time of submission of all new applications for Marketing Authorisations (MAs).
The structure of the PSMF is strictly controlled by the guidelines of the GVP, Module II. The PSMF must contain specified sections with details of the pharmacovigilance system. It is expected that:
Consequently the PSMF plays a pivotal role and requires expert knowledge to meet all of the regulator’s requirements.
The content of the file is defined in GVP Module II.There is no standard template, however PrimeVigilance have an established template in place. The following sections are provided as a generalised guideline to indicate the broad nature of the required content:
Additional annexes can be required and in all cases the content must be meticulously documented for compliance. All companies are advised to seek advice from professional pharmacovigilance service providers to ensure the content of the Pharmacovigilance System Master File complies with the regulatory requirements. For more information talk to our team today on +44 (0)1483 307 920.
+44 (0)1483 307920
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United Kingdom (Head Office)