Qualified Person for Pharmacovigilance

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A Qualified Person Responsible for Pharmacovigilance, or QPPV, is an individual named by a pharmaceutical company as the main person responsible for ensuring that the company (the holder of the Marketing Authorisation for the product or MAH) meets its legal obligations for the monitoring of the safety of the product on the market.

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 (a pharmacovigilance system) and proof that the services of a QPPV are in place.[1]

Criteria for QPPV role[edit]

The QPPV must reside in the EU, and should be permanently and continuously at the disposal of the MAH. 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 Volume 9 of "The rules governing medicinal products in the European Union."[2] At a minimum the QPPV should be appropriately qualified, with documented experience in all aspects of pharmacovigilance in order to fulfil the responsibilities and tasks of the post. If the QPPV is not medically qualified, access to a medically qualified person should be available.

In addition, there are national regulations in some EU Member States that also require a nominated individual in that country who has specific legal obligations as a QPPV at a national level.

References[edit]

  1. ^ See Article 8(3)(ia) of Directive 2001/83/EC http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_cons2009/2001_83_cons2009_en.pdf
  2. ^ EudraLex - Volume 9 Pharmacovigilance Guidelines http://ec.europa.eu/health/documents/eudralex/vol-9/index_en.htm