Collection

Apply for veterinary medicine authorisations

Guidance and application forms for Marketing Authorisations, Animal Test Certificates, Veterinary Homeopathic Remedies, Batch release and Batch control, Export and Import certificates.

• From: Veterinary Medicines Directorate
• Published: 19 December 2014
• Last updated: 5 October 2022 — See all updates

For information about applying for any of the following, please see the relevant guidance page:

• Specific Manufacturing Authorisations:
  • Autogenous Vaccine Authorisation (AVA)
  • Non-food Animal Blood Bank (NFABB)
  • Animal Stem Cell Centre Authorisation (ASCCA)

Marketing authorisations - application related

• Marketing Authorisation Holders, Named Distributors and Local Representatives of veterinary medicines
  • 17 May 2024
  • Guidance
• Apply for a Marketing Authorisation in the UK for a veterinary medicine or expiry
  • 13 June 2024
  • Guidance
• Submission of an application for a veterinary marketing authorisation
  • 17 May 2024
  • Guidance
• Veterinary Medicines Regulations Annex 2 Requirements
  • 17 May 2024
• Summary of Product Characteristics and product literature for veterinary medicines
  • 29 April 2024
  • Guidance
• Product Literature Standard (PLS) for veterinary medicines
  • 29 April 2024
  • Guidance
• Product Information Templates for Veterinary Medicines (SPC and QRD Text)
  • 7 August 2024
  • Guidance
• Validation of applications for veterinary medicines
  • 27 June 2022
  • Guidance
• Timetables for national applications for MAs, ATCs and VHRs
  • 12 December 2024
  • Guidance
• Apply to submit conditional or commitment data for assessment
  • 27 November 2014
  • Form
• Joint assessment for veterinary medicines for use in the UK and Ireland
  • 20 May 2024
  • Guidance

Apply for ATC

• Apply to run a clinical trial using a medicine for an animal
  • 20 December 2024
  • Form

Veterinary Homeopathic Remedies (VHRs)

• How to register a Veterinary Homeopathic Remedy (VHR)
  • 17 May 2024
  • Guidance

Post authorisation activities

• Apply to change a veterinary Marketing Authorisation or Homeopathic Remedy
  • 18 December 2024
  • Guidance
• Apply for batch release of an immunological veterinary medicine
  • 20 April 2022
  • Guidance
• Apply for specific batch control of a pharmaceutical veterinary medicine
  • 1 April 2019
  • Guidance
• Suspension or expiry of a veterinary Marketing Authorisation, Homeopathic Remedy or Animal Test Certificate
  • 31 March 2016
  • Guidance

Fees

• Fees applied to veterinary medicine authorisation applications in GB
  • 21 November 2024
  • Guidance
• Fees applied to veterinary medicine authorisation applications in Northern Ireland
  • 4 July 2024
  • Guidance
• Annual fees for marketing authorisation holders for veterinary medicines
  • 16 May 2024
  • Form
• Payment of application fees for veterinary medicines
  • 13 June 2024
  • Guidance

Import / Export of veterinary medicines

• Import a medicine for veterinary use into the UK
  • 7 September 2021
  • Guidance
• Export drugs and medicines: special rules
  • 19 March 2024
  • Guidance

Published 19 December 2014
Last updated 5 October 2022 + show all updates

1. 5 October 2022

   Reviewed and updated headings and links to application guidance

2. 15 October 2019

   Addition of applications forms; new marketing authorisation, variation and renewal of a marketing authorisation.

3. 30 November 2018

   Guidance for Parallel Import of veterinary medicines added

4. 26 February 2018

   Restructured collection of guidance content with additional articles added

5. 19 December 2016

   Guidance added 'Apply to change Marketing Authorisation Holder, Distributor or Local Representative details added to Veterinary Medicines Application Forms'

6. 19 December 2014

   First published.