Pharmacovigilance System Master File

 What is a PSMF?

A legal requirement for any medicinal product authorized in the European Union (EU) is known as Pharmacovigilance System Master File (PSMF). The PSMF provides a description of the entire pharmacovigilance system for the organization and documents the performance and compliance with the requirements as per Good Pharmacovigilance Practices (GVP).The Applicant/Marketing Authorization Holder is responsible for establishing the Pharmacovigilance System Master File and for registering the master file location with the competent authorities in the marketing authorization application and in the XEVMPD (Extended EudraVigilance medicinal product dictionary (XEVMPD) training

Objective Of PSMF

• Describe the pharmacovigilance system.

• Support/document the PV system’s compliance with the requirements

Provides Information on -

• Aspect of compliance in relation to the system

• Deficiencies in the system, non-compliance with a requirement

• Risk or actual failure in conduct of specific PV aspects and

• The action/measure taken

Contribute to -

• The fulfillment of supervisory responsibilities of qualified personnel for PV activities (QPPV),

• Planning and conduct of internal audits and

• External inspection/verification of compliance by national competent authorities (NCAs)

• Appropriate management and improvement to the pharmacovigilance system

• Thereby, assuring PV system implementation and compliance

Why do companies need PSMF:

To strengthen and rationalize the monitoring of the safety of medicinal products, and for PV activities harmonization, legal requirement for MAHs, to maintain and make the PSMF available upon request, The content of any PSMF should display global availability of the safety information for medicinal products authorized in the region.

PSMF Required in other countries:

• Recently estimated figure suggested that over 30 Countries across the globe, now has requirements of PSMF

• Countries govern by the league of Arab states accept the EU-PSMF, but required additional documents such as PV system and sub file

• Meanwhile India requires MAH to maintain PSMF, where the main PV activities takes place

• ICH regions namely Japan PMDA as well as Health Canada or USFDA do not mandate PSMF. However, all the health authorities can request for of an EU PSMF, if MAH product has registered in EU

How should PSMF be maintained?

• In the EU, the PSMF must be located, either at the site where the main PV activities are performed or where the qualified person for PV(QPPV) operates.

• The required location information for the PSMF is the physical office address of the MAH or contracted third party.

• If the MAH holds approvals in only one Member State, this document should not be written in English, it can be written in the EU official language for that territory. Effective January 1, 2021, MAHs need to ensure that the UK PSMF is located at the same point in the UK post-Brexit transition, from where the reports of suspected adverse reactions are referred to. 

• The document could be stored either in paper or in electronic form. This document could virtually existing on different servers in the company, or at suppliers of data services, but for the inspection systematically arranged printed copy needs to be provided.

Content of PSMF:

• Indexed with appropriate sections for efficient navigation

• Partitioned

• Sections  

• Annexes

References:

https://allaboutpharmacovigilance.org/pharmacovigilance-system-master-file-psmf/

https://www.qvigilance.com/pharmacovigilance-system-master-file

https://voisinconsulting.com/resources/glossary/pharmacovigilance-system-master-file-psmf

Kiran Rathi

Clinosol ID: 191/1022

M.Sc. (Organic Chemistry)

kiranrathi931@gmail.com