Qualified Person for Pharmacovigilance (QPPV)

This post will give you a brief understanding about who a QPPV is and what his roles ad responsibilities are.

Introduction – Qualified Person for Pharmacovigilance (QPPV)

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. 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.

“The holder of an authorisation for a medicinal product for human use granted in accordance with the provisions of this Regulation shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance.”

The QPPV must reside in the European Union. Per Article 23, the QPPV is responsible for:
a) Establishing and maintaining a pharmacovigilance system
b) Preparing pharmacovigilance reports as defined by regulations
c) Answering requests from Health Authorities
d) Providing Health Authorities with any other information relevant to product safety

Volume 9A provides further guidance regarding these responsibilities of the QPPV (Part I, Chapter 1.2, Section 1.2.1: The Role and Responsibilities of the Qualified Person Responsible for Pharmacovigilance).

Per Volume 9A, the QPPV is responsible for “overall pharmacovigilance for all medicinal products for which the company holds marketing authorisations within the EU”, and specifically for:

  • Establishing and maintaining/managing the pharmaceutical company’s pharmacovigilance system
  • Having an overview of the safety profiles and any emerging safety concerns for the company’s drugs
  • Acting as a single contact point for the Health Authorities on a 24-hour basis

Criteria – Qualified Person for Pharmacovigilance (QPPV)

A QPPV must meet the following criteria:

  • Have experience in all aspects of pharmacovigilance and if not medically qualified (do not have a medical degree) should report to, or have access to a medically qualified person.
  • Be resident within the European Economic Area.
  • The Qualified Person for Pharmacovigilance must be a resident within the EU.
  • The name of the Qualified Person for Pharmacovigilance should be provided to the relevant competent authorities within the EU.
  • The Qualified Person for Pharmacovigilance must be permanently and continuously available.
  • A Qualified Person for Pharmacovigilance is required even if products are not marketed.
  • It should be noted that the Qualified Person for Pharmacovigilance can be held liable for prosecution if the pharmacovigilance requirements of the directive are not met.

The position of Qualified Person for Pharmacovigilance can be held either within the company or contracted out. If the position is contracted out it is important to ensure a clear contract outlining the roles and responsibilities held by that individual is implemented and a copy of the contact may need to be provided to the competent authority.

This completes our discussion on Qualified Person for Pharmacovigilance (QPPV). We hope this gives you flavour the role of Qualified Person for Pharmacovigilance (QPPV) and a flavour of this allied science.

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