Collection

Apply for product authorisations

Guidance and application forms for a Marketing Authorisation, Animal Test Certificate, Veterinary Homeopathic Remedy, Autogenous Vaccine Authorisation or Export certificate.

Guidance on applying for a Marketing Authorisation (MA), Animal Test Certificate (ATC), Veterinary Homeopathic Remedy (VHR), Autogenous Vaccine Authorisation (AVA), or Export Certificate.

Overview

Apply for

  1. Apply for a Marketing Authorisation for a veterinary medicine or expiry
  2. Apply to register or renew a Veterinary Homeopathic Remedy (VHR)
  3. Apply for a new Animal Test Certificate (including Type-S) or to renew or change an existing certificate
  4. Apply to change a veterinary marketing authorisation or homeopathic remedy
  5. Apply to renew a marketing authorisation for a veterinary medicine
  6. Apply to change Marketing Authorisation Holder, Distributor or Local Representative details
  7. Veterinary Medicines: Apply for and maintain a Joint-Label for use in the UK and Ireland
  8. Apply to submit conditional or commitment data for assessment
  9. Apply for specific batch control of a pharmaceutical veterinary medicine
  10. Apply for batch release of an immunological veterinary medicine
  11. Export drugs and medicines: special rules
  12. Apply for an Autogenous Vaccine, Non-Food Animal Blood Bank, Equine Stem Cell Centre Authorisation

Guidance

Application forms

Application forms are available on the European Commission website except the following:

For reference to Exceptional MAs (Limited and Provisional) see ‘Apply for a Marketing Authorisation for a veterinary medicine’.

Announcements / MAVIS articles

Marketing Authorisations Veterinary Information Service (MAVIS). Current and previous editions of the newsletter.

  1. Veterinary medicines: Changes to distributor and local representatives details
  2. New version of the product literature standard
  3. Veterinary medicines containing zinc oxide: European referral outcome
  4. Changes to publishing licensing information in MAVIS
  5. QRD text for Nationally Authorised Veterinary Medicinal Products
  6. Changes to the way you submit mock-up veterinary medicine product literature
  7. Changes to the way mock-ups are dealt with: Guidance for Marketing Authorisation Holders
  8. Copycat Marketing Authorisation: Change to variation validation procedure
  9. Marketing authorisation certification: clarification of date of issue
  10. Renewal Reminders: Marketing Authorisations and Veterinary Homeopathic Remedies
Published 19 December 2014
Last updated 26 February 2018 + show all updates
  1. Restructured collection of guidance content with additional articles added
  2. Guidance added 'Apply to change Marketing Authorisation Holder, Distributor or Local Representative details added to Veterinary Medicines Application Forms'
  3. First published.