Understanding PSMF and Role of QPPV in Pharmacovigilance

Hello Guys,

In this article, we will see about Pharmacovigilance System Master File (PSMF) and role of Qualified Person responsible for Pharmacovigilance (QPPV).

PSMF is a detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to one or more authorised medicinal products.

The PSMF shall be located either at the site in the European Union (EU) where the main pharmacovigilance activities of the marketing authorisation holder are performed or at the site in the EU where the qualified person responsible for pharmacovigilance (QPPV) operates.

It is a requirement of the marketing authorisation application that summary information about the pharmacovigilance system is submitted to the competent authorities. This summary includes information on the location of the PSMF.

Objectives of PSMF

The PSMF shall describe the pharmacovigilance system and support/document its compliance with the requirements.

It shall contribute to the appropriate planning and conduct of audits by the applicant or marketing authorisations holder(s), the fulfilment of supervisory responsibilities of the QPPV, and of inspections or other verification of compliance by national competent authorities.

The PSMF provides an overview of the pharmacovigilance system, which may be requested and assessed by national competent authorities during marketing authorisation application(s) or post-authorisation.

Through the production and maintenance of the PSMF, the marketing authorisation holder and the QPPV should be able to: 

  1. gain assurance that a pharmacovigilance system has been implemented in accordance with the requirements;
  2. confirm aspects of compliance in relation to the system;
  3. obtain information about deficiencies in the system, or non-compliance with the requirements;
  4. obtain information about risks or actual failure in the conduct of specific aspects of pharmacovigilance.
Content of PSMF

The content of the file is defined in GVP Module II. There is no standard template, however, the following sections of the PSMF main body are provided as a generalized guideline to indicate the broad nature of the required content:

  1. Details of the qualified person responsible for pharmacovigilance (QPPV)
  2. Details of the organization structure of the company that actually holds the Marketing Authorisation or applies for the Marketing Authorisation
  3. Details of all of the sources of the relevant safety data
  4. Details of all electronic (computerized) systems and databases
  5. Details of all pharmacovigilance processes
  6. Details of the performance of all drug safety systems
  7. Details of all quality control systems
  8. Annexures


In the European Union, the Qualified Person Responsible For Pharmacovigilance (QPPV) is an individual, usually an employee of a pharmaceutical company, who is personally responsible for the safety of the human pharmaceutical products marketed by that company in the EU. 
  1. This function was established in 2004 by article 23 of regulation (EC) No 726/2004. The article establishes that the holder of a marketing authorization for a drug for human use must have a QPPV. 
  2. When a company submits an application for permission to bring a medicinal product onto the market, the company submits a description of its system for monitoring the safety of the product in actual use and proof that the services of a QPPV are in place.
Responsibilities of QPPV

The QPPV is responsible for:

  1. Establishing and maintaining a pharmacovigilance system
  2. Preparing pharmacovigilance reports as defined by regulations
  3. Answering requests from Health Authorities
  4. Providing Health Authorities with any other information relevant to product safety
  5. Having an overview of the safety profiles and any emerging safety concerns for the company’s drugs
  6. Acting as a single contact point for the Health Authorities on a 24-hour basis

Criteria of QPPV role
  1. The QPPV must reside in the EU, and should be permanently and continuously at the disposal of the MAH. 
  2. Each company (i.e. Applicant/Marketing Authorisation Holder or group of Marketing Authorisation Holders using a common pharmacovigilance system) should appoint one QPPV responsible for overall pharmacovigilance for all medicinal products for which the company holds marketing authorisations within the EU.
Detailed information on the role and responsibilities of the QPPV, and guidance for a Marketing Authorisation Holder on how to adequately support the QPPV are specified in Guideline on good pharmacovigilance practices (GVP; Module I – Pharmacovigilance systems and their quality systems).

Thank you for reading this article. If you have any query, please contact us at pvdrugsafetyinfo@gmail.com

PV Drug safety Team 

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