Veterinary medicines guidance note on how to get authorisation for clinical field trials of veterinary medicinal products.
This document relates to the procedures for an application for an Animal Test Certificate (ATC).
For individuals, organisations and companies who intend to conduct clinical field trials of substances that are expected to fall within the definition of a veterinary medicinal product (VMP). The definition of a VMP is provided in VMGN 1: Controls of Veterinary Medicines.
An ATC authorises the trial itself and the procurement and supply of the veterinary medicine used.
In this context, a clinical field trial is a study whose purpose is to demonstrate the efficacy and/or safety of a veterinary medicine in the target species under conditions of field use.