The large number of species and breeds that are treated with Veterinary Medicinal Products (VMP) requires these products to be specialized, for different pathologies and animal behaviors, in order to recognize an adverse event and then correctly manage it. As an animal is not able to communicate directly with a human, the Veterinary Surgeon (Vet) is the person that is able to translate its behavior into concrete clinical evidence and understand if the VMP that has been administered is working as expected or if it is causing an adverse reaction to the animal. With the Regulation (EU) 2019/6, in force since January 2022, new rules are in place in order to guarantee that all the Suspected Adverse Events (SAE) that occurred after the use of a Veterinary Medicinal Product are properly reported to the Marketing Authorization Holder (MAH), who has the responsibility for the management of the safety of the products, or to the Competent Authorities (CA)s, and that they are evaluated in order to assess their impact on benefit-risk balance of the product.
The initial results since the implementation of the new system show that more than 160,000 cases were reported on EudraVigilance Veterinary (EVVet) in 2022, including non-serious cases, with a 30,000 backlog from one holder, versus the 60,000 reported in 2021, meaning that companies and Vets are more sensitive to the safety of the VMPs administered and to the health of the animal. As compared to Human Medicinal Products, although extensive testing is carried out on the safety and efficacy of veterinary medicines before the marketing authorization, information on adverse events that an animal or a user may experience is still relatively limited. Certain interactions as well as rare adverse events or events specific to certain breeds or groups of animals may only be identified when the product is used more widely. The main source of reporting of suspected adverse events in Veterinary Medicine are the animal healthcare professionals (aHCP), precisely in the figure of the Vet. With the new regulation, the Vet has become the main character for the protection of public and animal health and of the environment, contributing to the good use of veterinary medicinal products.