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).

Documents

Application form: ATC Type A or B Pharmaceutical

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Application form: ATC Type A or B Immunological

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Application form: ATC Type S

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ATC label proforma

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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.

Updates to this page

Published 26 November 2014
Last updated 3 February 2020 + show all updates
  1. EU/EEA and other third countries" is replaced by "EEA, USA, Canada, Japan, New Zealand or Australia

  2. Updated Application forms added

  3. Updated Immunological application form

  4. Updated Immunological/Biological Product Form

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

  6. Application form attachments changed to Word versions

  7. First published.

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