Ensure Your Pharmacovigilance (PV) System Meets European Regulatory Requirements
The QPPV and LPPV roles are critical for ensuring compliance with European regulatory requirements and the safety of products marketed in the EU. Appointing the right EU QPPV can require considerable time and resources, which is why some organizations are outsourcing this role to experienced third parties. Learn about the importance of a QPPV and LPPV along with information on our services to help with your pharmacovigilance operations.
Role of the EU QPPV
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 MAH must appoint an EU Qualified Person for Pharmacovigilance (QPPV) to establish and maintain the MAH’s PV system. In addition to the establishment and oversight of the PV system, the QPPV also has several legislative responsibilities.
Responsibilities of the EU QPPV include:
- Establish and maintain the MAH’s PV system
- Monitor the safety of the MAH’s drug products
- Coordinate actions to stay compliant with local legislation
- Serve as the 24/7 point of contact for Competent Authorities
- Conduct audits and inspections to ensure compliance with EU regulations
Role of an LPPV
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. While the requirements and responsibilities of an EU QPPV are specified in EU legislation, LPPVs are subject to their own national legislation.
Some QPPVs may have their own network of LPPVs to help fulfill local requirements. 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.
Get Expert Guidance Managing Legislation Requirements
ProPharma Group can support your organization through the provision of appropriately qualified and experienced QPPVs, LPPVs, and deputies, as well as help your PV team prepare for Brexit.
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. Contact us to learn more about out QPPV and LPPV services.