EU Qualified Person (QPPV)
Medicinal products cannot be marketed within the European Economic Area (EEA) without a Qualified Person for Pharmacovigilance (QPPV)1. The Qualified Person for Pharmacovigilance is personally responsible in law for the fulfilment of 3 key functions:
- Establish and maintain the Market Authorisation Holder’s (MAH) Pharmacovigilance System (including all activities which contribute to the detection, assessment, understanding and communication of safety information, as well as risk management activities).
- Oversee the safety profiles of the company’s marketed products and any emerging safety concerns.
- Act as a single point of contact for the regulatory Authorities on a 24-hour basis, and provide the contact point for pharmacovigilance inspections.
The Qualified Person for Pharmacovigilance must be “permanently and continuously at the disposal” of the MAH and must be experienced in all aspects of Pharmacovigilance. This is often a challenge for small to medium sized companies, as the Qualified Person for Pharmacovigilance must reside within EEA, and a deputy may be needed as well. Often, companies who are emerging into Europe either do not have infrastructure locally, or do not have access to an appropriate individual.
1Brown EG. The Qualified Person for Pharmacovigilance for Europe: a compliance and quality perspective. Leading article. Int J Pharm Med 2005; 19 (1): 7-14QPPV: Compliant and Qualified
For more information contact PrimeVigilance today