Guidance

Animal test certificates (VMGN 6)

Veterinary medicines guidance note on how to get authorisation for clinical field trials of veterinary medicinal products.

From:
Veterinary Medicines Directorate
Published
31 July 2013

This publication was withdrawn on

Replace by revised guidance Apply for an animal test certificate

Documents

Animal Test Certificates (ATCs)

Ref: VMGN No. 6

PDF, 324 KB, 39 pages

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Details

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.

Published 31 July 2013