EU QPPV and Local QPPVs

Qualified Person for Pharmacovigilance

The appointment of a European Union (EU) Qualified Person for Pharmacovigilance (QPPV) is a mandatory requirement for all medicinal products authorised within the EU and they are responsible for ensuring that the Marketing Authorisation Holder’s pharmacovigilance system is compliant with EU requirements. Outsourcing the QPPV function can provide a cost-effective solution to gaining access to the required expertise of a QPPV based within the EU. QVigilance can provide an experienced EU QPPV to support and oversee a client’s portfolio.

EU QPPV SERVICES

Our QPPVs will support and oversee the following activities:

EU local pharmacovigilance representatives

In certain member states within the EU, there is a requirement for the nomination of a pharmacovigilance person at national level. The role of these local representatives (often referred to as local QPPVs or National Persons Responsible for Pharmacovigilance (NPRPs)), is to provide a local contact person for the National Competent Authority (NCA) in the member state who usually must be fluent in the language and may be required to be resident of that country. The local representative may also be required to oversee the local PV system for collection and reporting of safety information to the concerned NCA, monitor local (non-indexed) literature for relevant safety information and act as the contact person of regulatory inspections by the NCA.

QVigilance can not only offer support in understanding which EU countries require a local representative but can also provide a network of local representatives in these individual countries to meet any specific local pharmacovigilance requirements

Non-EU local pharmacovigilance representatives

Additionally, QVigilance can provide or source local safety affiliate representatives in countries outside the EU, as required.

QVigilance can provide or source Local QPPV in the following countries:

Belgium - France - Germany - Italy - Poland - Netherlands Spain - Bulgaria - Croatia - Cyprus  - Czech - Estonia   Greece - Hungary - Latvia - Portugal - Slovakia

NEED TO OUTSOURCE QPPV SERVICES?

Whether European, Regional or local, we can provide with the right representative for you!

Submit an RFI