Guidance

Exemptions for marketing medicines for small pet animals (VMGN 12)

For manufacturers on the requirements for products manufactured under Schedule 6 of the VMR – Exemptions for small pet animals

From:
Veterinary Medicines Directorate
Published
31 July 2013

This publication was withdrawn on

Guidance replaced by Exemption from authorisation for medicines for small pet animals

Documents

Exemptions for small pet animals

Ref: VMGN No. 12

PDF, 226 KB, 10 pages

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Details

Requirements to be met by manufacturers of products marketed under Schedule 6 of the Veterinary Medicines Regulations (VMR) – Exemptions for small pet animals.

This provision in the VMR allows a manufacture to be exempt from the requirement to hold a Marketing Authorisation (MA) for selected minor species, providing certain criteria are met. The exemption applies to;

  • aquarium animals
  • caged birds
  • homing Pigeons
  • terrarium Animals
  • small Rodents
  • ferrets
  • rabbits

The criteria is that the active ingredient of the product must be approved. It will not be approved if the substance requires veterinary control or if the product is an antibiotic or contains any narcotic or psychotropic substance. Administration of the product must be oral or topical, or for fish products by addition to water. Products can only be sold in pack sizes that are for a single course of treatment.

Products must be manufactured in accordance with Good Manufacturing Practice (GMP) and labelled correctly with a statement to show they are exempt from the statutory requirement for an MA.

Published 31 July 2013

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