Supriya Ghosh (Editor)

Qualified Person Responsible For Pharmacovigilance

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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:

  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

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
  • References

    Qualified Person Responsible For Pharmacovigilance Wikipedia