The QPPV: An Essential Guide To The Qualified Person Responsible For Pharmacovigilance

When submitting marketing authorization applications (MAAs) in Europe, the applicant (Marketing Authorization Holder, MAH) must have a pharmacovigilance system in place. This includes a summary of the pharmacovigilance system and proof of a Qualified Person Responsible for Pharmacovigilance (QPPV), who is central to this system. EU legislation defines the QPPV's responsibilities, which include overseeing all aspects of pharmacovigilance (PV) for products within the European Economic Area (EEA) and Northern Ireland. For UK MAs, a UK QPPV is required, and if they do not reside in the UK, a UK Local Person for Pharmacovigilance (LPPV) is needed.

The QPPV, whether an internal or contract employee, must be continuously available to the MAH. Their main responsibilities include maintaining the PV system and overseeing the safety profile of medicinal products. This involves managing the quality system, handling compliance data, ensuring timely reporting, and supervising the PV tasks delegated to qualified individuals.

To enhance QPPV oversight, it is essential to provide proper training, update the Pharmacovigilance System Master File (PSMF) regularly, include QPPVs in relevant meetings, and grant access to necessary databases and reports. ProPharma offers experienced QPPVs to support your products. Read the full article below to learn more about how ProPharma can assist you in maintaining a compliant PV system.