{"id":621,"date":"2026-09-20T18:13:56","date_gmt":"2026-09-20T16:13:56","guid":{"rendered":"https:\/\/www.pqra.gr\/building-a-veterinary-pharmacovigilance-system-under-regulation-eu-2019-6\/"},"modified":"2026-09-20T18:14:00","modified_gmt":"2026-09-20T16:14:00","slug":"building-a-veterinary-pharmacovigilance-system-under-regulation-eu-2019-6","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/building-a-veterinary-pharmacovigilance-system-under-regulation-eu-2019-6\/","title":{"rendered":"Building a Veterinary Pharmacovigilance System Under Regulation (EU) 2019\/6"},"content":{"rendered":"

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.<\/strong><\/p>\n\n

The master file is the system<\/h2>\n

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.<\/p>\n

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.<\/p>\n\n

Continuous signal management<\/h2>\n

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.<\/p>\n\n

What a workable system needs<\/h2>\n