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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