EU Qualified Person for Pharmacovigilance (QPPV)

Within the EU, each Marketing Authorisation Holder of human, veterinary or herbal medicinal products should ensure to have at his disposal a single point of contact, with a deputy, who is available 24/7 to act as the Qualified Person for Pharmacovigilance (QPPV). The QPPV has the following prime responsibilities:

  • 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 products (independent of their marketing status) and any emerging safety concerns and coordinate communication of these to competent authorities.
  • Act as a single point of contact for competent authorities on a 24-hour basis, and act as the contact point for pharmacovigilance inspections.

The QPPV must be “permanently and continuously at the disposal” of the MAH and must be experienced in all aspects of pharmacovigilance. The QPPV must reside and work within the European Economic Area (EEA), and an adequate back-up procedure is required as well. DADA can provide you with a QPPV and a deputy QPPV. Depending on your wishes, you may outsource all or some of your pharmacovigilance activities to our pharmacovigilance department, next to obtaining the services of an QPPV. In addition, through its network of Regulatory Affairs and Pharmacovigilance agencies and partners, DADA can provide local responsible persons for pharmacovigilance in applicable EEA-territories.