Guidance

Manufacturing authorisations for veterinary medicines (VMGN 15)

Veterinary medicines guidance note for manufacturers who need to comply with the principles of good manufacturing practice (GMP).

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Documents

Manufacturing Authorisations

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Details

How manufacturers must comply with the principles of good manufacturing practice (GMP) for:

  • Manufacturing Authorisation (ManA) - Manufacture or importation of authorised veterinary medicinal products (VMPs), including manufacture and import for exportation
  • Manufacturing Extemporaneous Products (Specials) Authorisation (ManSA) - Manufacturers of extemporaneous VMPs (also known as Specials) for use in accordance with the prescribing cascade
  • Autogenous Vaccine Authorisation (AVA-I/S) - Manufacture of autogenous vaccines (a vaccine prepared from a pathogen extracted from a host animal or group which is then used to inoculate the rest of the group)
  • Non Food Animal Blood Banks Authorisation (NFABBA) - Collection, storage and supply of whole or fractionated blood for use in animals, which are not used as food
  • Equine Stem Cell Centre Authorisation (ESCCA) - Equine Stem Cell Centres for collection, storage, processing, production and administration of equine stem cells used for autologous treatment of horses
  • Exemptions for Small Pet Animals - Placing on the market, manufacture or importation of a product intended for administration to small non-food producing pet animals

If you are a manufacturing site handling both human and veterinary medicines you should also refer to guidance published by the Medicines and Healthcare products Regulatory Agency (MHRA).

Enquiries to:

Telephone: 020 3080 7400
Email: MHRA contact form.

Published 31 August 2014