Live Support

pharmacovigilance system master file

What is Pharmacovigilance System Master File?

The sheer work of Pharmacovigilance is to ensure the security of the growth and development of medicinal products. The Pharmacovigilance System Master File (PSMF) is a lawful prerequisite in the EU. This direction concerns the supplies for the PSMF and is relevant for any medical good allowed in the EU, irrespective of the marketing authorization modus operandi. The requisite matter and management of the PSMF is valid irrespective of the directorial structure of a marketing-authorization holder, counting any delegation of actions, or their position.

The matter of the PSMF must imitate international accessibility of security info for medical goods approved in the EU, with information on the pharmacovigilance arrangement not just limited to confined or local activities.

Owing to the maintenance and construction of PSMF the marketing-authorization holder and the QPPV should be able to:

  • Win guarantee that a pharmacovigilance system has been put into operation in agreement with the necessities
  • Verify facets of agreement in relation to the system
  • Gather info concerning shortcomings in the system, or nonconformity with the necessities;
  • Attain info about danger or actual stoppage in the conduct of certain aspects of pharmacovigilance.

Info to be contained in the PSMF

The Pharmacovigilance System Master File must comprise of papers to explain the pharmacovigilance system. The matter of this must replicate the worldwide accessibility of security information for medical products sanctioned in the EU. The matter must be indexed to permit for competent course-plotting about the file.