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About: Qualified Person Responsible For Pharmacovigilance     Goto   Sponge   NotDistinct   Permalink

An Entity of Type : dbo:Person, within Data Space : dbpedia.demo.openlinksw.com associated with source document(s)

Type: Thingperson New Facet based on Instances of this Class

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. 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.