Having a veterinary pharmacovigilance system and a qualified person responsible for pharmacovigilance (QPPV) is a legal obligation for veterinary medicinal product marketing authorisation holders. The Veterinary Medicinal Products Unit carries out checks and inspections in relation to these legal requirements.
Inspections may be performed either on site or remotely. If deficiencies are found in the system, they will be mentioned in the inspection report. As a marketing authorisation holder, you can respond to that report with a CAPA (corrective and preventative action) plan. Your plan will be assessed and included in the final inspection report.
If major gaps are found in the pharmacovigilance system during the inspection, a re-inspection will be performed.
The frequency of inspection for each marketing authorisation holder is based on risk. In other words, it could be based on the quality of the reports submitted or the quality of the signal management process.
There are several possible types of inspection:
- a full routine inspection, where the inspectors visit the site;
- a full remote inspection, involving video conversations via the Internet;
- A PSMF inspection. The PSMF must be sent to the inspectors, who will then inspect it;
- A ‘triggered inspection’.
Read the VGVP Guidelines for more information.
Legal basis
Section 5 of the Veterinary Medicinal Products Regulation (Articles 73 to 81, Articles 123 and 126) describes the rules relating to the monitoring of veterinary medicines. Implementing Regulation (EU) 2021/1281 and the Implementing Act on Good Pharmacovigilance Practices provide more details. Articles 126 and 126 of the Regulation and Sections 26 and 27 of the Implementing Act on Good Pharmacovigilance Practices set out the legal basis for inspections and checks relating to veterinary pharmacovigilance.
More information
If you still have questions about pharmacovigilance inspections, contact the Veterinary Medicinal Products Unit.
Note: This Regulation has completely changed the rules relating to veterinary pharmacovigilance. It is expected that the procedures will be clarified further over the next few years, and guidance documents will be supplemented or amended. As soon as this happens, we will amend the above text. You can always find the latest information about the new pharmacovigilance rules on the EMA Pharmacovigilance website.