QPPV: qualified person responsible for pharmacovigilance
The QPPV is the named individual, resident in the EU, who is personally responsible for a marketing authorisation holder's pharmacovigilance system.
Article 104(3)(a) of Directive 2001/83/EC requires every marketing authorisation holder to have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance, who must reside and operate in the Union. Article 104(4) lets a Member State also require a nationally based contact person who reports to the QPPV. GVP Module I describes the role: the QPPV oversees the pharmacovigilance system as described in the pharmacovigilance system master file, has an overview of the safety profile of every product the holder markets, acts as the single contact point for the authorities and for inspections, and must be able to ensure that the holder responds fully and promptly to any request for additional information.
The QPPV's name and contact details are submitted with every marketing authorisation application, recorded in the Article 57 database and kept current there; since 2013 a change of QPPV is no longer a variation: the holder updates the Article 57 database record, and the summary of the pharmacovigilance system in Module 1.8.1 is brought into line at the next variation that touches it. The holder must register the QPPV in EudraVigilance so that case reports can be sent and signal monitoring performed, and must appoint a deputy to cover absences. One QPPV may serve several holders in a group, but each holder must have one named person.
The role carries personal responsibility: a QPPV must have the authority to influence the pharmacovigilance system and the safety-related decisions of the company, and authorities can take action against the holder if the QPPV is not in a position to do so. The person needs medical or scientific training and documented experience in pharmacovigilance, although the law does not prescribe a specific qualification.
What goes wrong: the QPPV is a consultant with no real authority over local affiliates, so the system described in the PSMF does not match what happens; the deputy is named but never trained; a change of QPPV is made internally but not notified to EMA or the national authorities; the QPPV lives outside the EEA, which after the UK's withdrawal caught many companies; and the person covers so many holders that the continuous availability the law requires is not realistic. Each is a recurring pharmacovigilance inspection finding.
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QPPVs and their deputies assign each pharmacovigilance obligation to an owner and track it to closure in the obligation-to-action workflow.
Related terms
- PSMF: pharmacovigilance system master fileThe pharmacovigilance system master file (PSMF) is the holder's detailed description of its pharmacovigilance system, kept in the EU for inspectors.
- EudraVigilance: EU adverse reaction databaseEudraVigilance is the EU system for collecting, managing and analysing suspected adverse reaction reports for medicines authorised in the EEA.
- xEVMPD: extended EudraVigilance medicinal product dictionary (Article 57 database)The xEVMPD, or Article 57 database, is EMA's record of every medicine authorised in the EU, which holders must keep updated within 15 days of changes.
- Signal detection: identifying new safety information from pharmacovigilance dataSignal detection is the process of finding information that suggests a new or changed causal link between a medicine and an adverse event.
- MAH transfer: transfer of a marketing authorisation to a new holderAn MAH transfer moves a marketing authorisation from one legal entity to another, making the new company legally responsible for the product.
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