Role and responsibilities of the qualified person responsible for pharmacovigilance
The role and responsibilities of the qualified person responsible for veterinary pharmacovigilance (QPPV) are extensively described in Regulation (EU) 2019/6 and in the Guideline on veterinary good pharmacovigilance practices (VGVP), module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files.
Local or regional representative
The marketing authorisation holder (MAH) must have a local or regional representative who is able to receive reports of suspected adverse reactions and who is at all times capable of receiving, handling, responding to, and following up reports from Belgian citizens and healthcare professionals in at least the three national languages (Dutch, French and German).
If this cannot be ensured directly by the person concerned, a documented system must be in place to guarantee that reports can still be received, handled, answered and followed up in at least these three national languages.
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