Veterinary pharmacovigilance under Regulation (EU) 2019/6 is not a scaled-down version of the human system. It is built around continuous signal management rather than routine periodic reporting, it is documented in a pharmacovigilance system master file, and it has to account for adverse events in animals, in humans exposed to veterinary products, and in the environment. Companies that port a human system across without redesigning it usually discover the mismatch during an inspection.
The master file is the system
Every marketing authorisation holder must establish and maintain a pharmacovigilance system for the management of adverse events relating to its veterinary medicinal products, and describe that system in a pharmacovigilance system master file. The guidance on veterinary good pharmacovigilance practices sets out what the master file is expected to cover, and it is broader than a list of procedures. It addresses the quality management system supporting pharmacovigilance, including standard operating procedures, subcontracted activities, adverse event and signal management, risk management, communication, training, document control, performance monitoring, change control, auditing and corrective actions.
The practical test is simple. If an inspector reads your master file and then looks at how you actually work, do the two descriptions match? A master file that describes an aspirational system is worse than none at all.
Continuous signal management
Marketing authorisation holders must carry out signal management for their veterinary medicinal products, taking into account all relevant pharmacovigilance data they can reasonably be expected to be aware of, including sales data. This is an ongoing obligation rather than a periodic exercise attached to a report deadline. The emphasis sits on expedited reporting of adverse event reports regardless of seriousness, combined with a continuous signal management process.
What a workable system needs
- A named qualified person responsible for pharmacovigilance with genuine authority and veterinary-specific expertise.
- Case intake that captures reports from veterinarians, animal keepers, distributors and your own commercial staff.
- A signal detection method proportionate to the portfolio, with the rationale documented.
- Sales or exposure data integrated into signal review rather than held separately by commercial teams.
- Clear handling of lack of expected efficacy, human exposure events and environmental observations.
- An audit programme that actually tests the system, and a corrective action process that closes findings.
Outsourcing without losing control
Many companies delegate case processing or the qualified person role. Delegation is legitimate; abdication is not. Subcontracted activities belong in the master file, the contracts need to define responsibilities precisely, and the marketing authorisation holder retains accountability for the system as a whole.
How PQRA helps
PQRA builds and runs veterinary pharmacovigilance systems for marketing authorisation holders: drafting and maintaining the master file, providing or supporting the qualified person function, designing signal management processes, and auditing existing systems ahead of inspection. We work with companies establishing a veterinary presence in Greece and with multinationals aligning a local system to a global one.
To review your veterinary pharmacovigilance arrangements, contact PQRA.
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