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Glossary

Qualified Person for PharmacoVigilance (QPPV)

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Marketing Authorization Holders are responsible for monitoring the safety of products placed on the market.

Qualified Person for PharmacoVigilance

A Qualified Person for Pharmacovigilance is an individual residing within the European Economic Area (EEA), who is personally responsible by law for the safety of a human pharmaceutical product within the EEA. Applicants for Marketing Authorization have to provide regulatory authorities with a proof that the services of a QPPV are permanently and continuously in place.

QPPV key roles:

Establishing and maintaining a pharmacovigilance system;Acting as:

  • single point of contact for Competent Authorities on a 24-hour basis;
  • contact point for audits/inspections.

Overseeing the safety profiles of marketed products and any emerging safety concerns;

Ensuring conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and Good Vigilance Practices;

Ensuring a full and prompt response to any request from national Competent Authorities and from the European Medicines Agency;

Providing any other information relevant to the benefit-risk evaluation to the Competent Authorities in Members States and the EMA;

Ensuring and verifying that the Pharmacovigilance System Master File (PSMF) is constantly up-to-date and reflects the current pharmacovigilance system.

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