Form

Apply to run a clinical trial using a medicine for an animal

Application form for a licence to conduct a clinical trial using an animal medicine (animal test certificate).

• From: Veterinary Medicines Directorate
• Published: 26 November 2014
• Last updated: 3 February 2020 — See all updates

Documents

Application form: ATC Type A or B Pharmaceutical

Ref: #712897

ODT, 68.6 KB

This file is in an OpenDocument format

This file may not be suitable for users of assistive technology.

Request an accessible format.

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email postmaster@vmd.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Application form: ATC Type A or B Immunological

Ref: #713143

ODT, 54 KB

This file is in an OpenDocument format

This file may not be suitable for users of assistive technology.

Request an accessible format.

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email postmaster@vmd.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Application form: ATC Type S

Ref: #713603

MS Word Document, 76.4 KB

This file may not be suitable for users of assistive technology.

Request an accessible format.

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email postmaster@vmd.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

ATC label proforma

Ref: #104984

ODT, 8.9 KB

This file is in an OpenDocument format

This file may not be suitable for users of assistive technology.

Request an accessible format.

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email postmaster@vmd.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

You need an animal test certificate (ATC) type A or B, to conduct clinical trials to generate data in support of an application to get a licence (marketing authorisation) to market an animal medicine.

As a vet you need a ATC type S to conduct small scale research trials.

You must submit your application to the Veterinary Medicines Directorate.

To help you prepare your application read Animal Test Certificates guidance.

Submission guidance.

Labelling requirements are set out in the product literature standard.

All applications are checked (validated) upon receipt and you will then be sent an invoice for the fee.

Published 26 November 2014
Last updated 3 February 2020 + show all updates

1. 3 February 2020

   EU/EEA and other third countries" is replaced by "EEA, USA, Canada, Japan, New Zealand or Australia

2. 16 February 2018

   Updated Application forms added

3. 28 September 2017

   Updated Immunological application form

4. 11 July 2017

   Updated Immunological/Biological Product Form

5. 16 December 2016

   Updated Application forms added: ATC Type A or B Pharmaceutical ATC Type S

6. 31 March 2015

   Application form attachments changed to Word versions

7. 26 November 2014

   First published.