EVVet Management.
Safety management for veterinary products.

What is EVVet Management?

EudraVigilance Veterinary (EVVet), which is sometimes referred to as the Union Pharmacovigilance Database, is one of the systems that supports the implementation of the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6).

EVVet Management encompasses a wide range of responsibilities that parallel the extensive scope of pharmacovigilance activities typically associated with EudraVigilance in the context of human medicinal products. This comprehensive approach includes:

Recording Suspected Adverse Event Reports (AERs).

One of the core functions of EVVet Management is the systematic and meticulous recording of suspected adverse event reports. These reports provide invaluable information about potential adverse effects or unexpected reactions that may arise in animals treated with veterinary medicinal products.

Signal Detection and Data Analysis.

In alignment with pharmacovigilance principles, EVVet Management involves the vigilant monitoring of data related to veterinary medicinal products. This entails Signal Management; the detection of safety signals that may indicate previously unrecognized safety concerns. Rigorous data analysis is a key aspect of this process, helping to uncover hidden insights that could impact the safety of animal healthcare.

To achieve these objectives effectively and harmoniously, EVVet Management adheres to the pharmacovigilance reporting standards established by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

These standards maintain consistency and reliability in the reporting and evaluation of veterinary medicinal product safety. They serve as a common framework that both Marketing Authorization Holders and National Competent Authorities must adhere to, facilitating seamless collaboration and data exchange.

Compliance with these standards ensures that veterinary medicinal products are rigorously monitored, evaluated, and managed to minimize risks and maximize their benefits in animal healthcare.

Click for information from European Medicines Agency (EMA) on EVVet.

How can Aeigisana’s Pharmacovigilance team support you?

Technical EVVet Management expertise.

Our pharmacovigilance team boasts a wealth of experience in ensuring the compliance of Veterinary Medicinal Products (VMPs) and the specialized aspects of Veterinary Pharmacovigilance, including continuous Signal Management, variations in Adverse Event Reporting, and the effective utilization of EVVet.

Supporting all your VMPs.

Your success is our priority, so whatever your veterinary pharmacovigilance requirements are, our team is ready to provide you with the highest level of expertise, clear and effective communication, and unwavering reliability.