Necessity of an EU QPPV?
We have the availability to provide you with an EU Qualified Person for Pharmacovigilance (QPPV) or QPPV Deputy/ dQPPV within (veterinary) medicines. For human medicines a physician is on the background available and therefore complying the Directive and Guideline.
Within (veterinary) medicines, a EU QPPV will be available 24/7 for Marketing Authorisation Holder’s.
Maintaining the Eudravigilance/ EVVET Database for incoming Adverse Events is included.
Also there is a possibility for an interim External Pharmacovigilance or Regulatory Affairs (Veterinary) consultant and contact for the Authorities necessary for Distributors within the EU.
This all will be run from the office of Vet Online Consultancy and on companies location where necessary based on an Non Disclosure Agreement.