Form

Apply for a licence to prepare and sell an autogenous vaccine

An application form for an autogenous vaccine authorisation (AVA) for veterinary use.

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Documents

Application Form: New AVA

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Annex 1: Veterinary surgeon justification declaration

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Details

You must apply for an AVA for a vaccine manufactured from pathogens or antigens obtained from an animal/s and used for the treatment of that animal and/or other animals within the same epidemiological unit or in the same rearing chain.

The authorisation is granted for the method of production and the premises used to manufacture the vaccine.

You must submit your application to the Veterinary Medicines Directorate.

To help you prepare your application read Veterinary Medicines Guidance Note (VMGN) No. 15 – Manufacturing Authorisations.

Submission guidance.

All applications are checked upon receipt for completeness you will then be sent an invoice for the fee.

Application timescales are set out in Veterinary Guidance Note (VMGN) No. 18 - Release of Veterinary Medicinal Products to the UK Market.

Published 26 November 2014