Pharmacovigilance Site Master File (PSMF)

The PSMF is a permitted obligation in the many regulated agencies. The PSMF shall designate comprehensive explanation of pharmacovigilance system for the organization and provision/document its agreement with Good Pharmacovigilance Practices (GVP) requirements.

The pharmacovigilance system is described in the PSMF, which national competent authorities may request and evaluate during marketing authorization application or post authorization/regulatory inspection and audit. From time to time, It is compulsory for any MAH (Manufacturing Authorization Holder) to improve all Essential elements of PSMF accompanied by all the information in the Annexures (A to I).