Ensure Your Pharmacovigilance (PV) System Meets European Regulatory Requirements
Every Marketing Authorization Holder (MAH) in Europe has an obligation to establish a pharmacovigilance (PV) system for the fulfillment of pharmacovigilance tasks for its products. When setting up a PV system in Europe, the EU Qualified Person for Pharmacovigilance (QPPV) is critical to the initial creation and oversight of this PV system and the well-defined legislative responsibilities for this role.
Additionally, many European and other countries also legally require a Local Person for Pharmacovigilance (LPPV) at a country level who may report to the EU QPPV, e.g., for Germany a Stufenplanbeauftragter is required. As a global pharmacovigilance provider, ProPharma Group can advise you about the various important requirements for EU QPPVs and LPPVs, to ensure you have the right resources in place to fully comply with the regulations for your PV system in Europe.
Managing Legislation Requirements
While the requirements and responsibilities of an EU QPPV are specified in EU legislation, LPPVs are subject to their own national legislation. ProPharma Group can support your organization through the provision of appropriately qualified and experienced QPPVs, LPPVs, and deputies.
ProPharma Group’s experts can advise you about the different roles and responsibilities of the EU QPPVs and LPPVs and offer services that can accommodate your business needs and ensure compliance with the pharmacovigilance legislation unique to each location. We have a team of local persons available to fulfill these positions and strengthen your country PV operations as your company grows.