Guidance

Changes to the distribution category of an animal medicine

Explanation of changes that can be made to the way a veterinary medicine can be supplied to end users.

A marketing authorisation holder (MAH) of an animal medicine can submit an application to the Veterinary Medicines Directorate to request a change to their product’s details.

Once approved, the MAH is usually expected to implement the change to the marketed product within 6 months, ie any batch of product released by the Qualified Person (QP) of the company must reflect the approved change(s) from the date of implementation. This timescale may be longer or shorter depending on the change involved.

A product may only be distributed on the market place in accordance with the distribution category shown on the product label.

Until the change in distribution category has been implemented onto the packaging of a product, you should use the product in accordance with the distribution category shown on the product label.

For further information about distribution categories see Retail of veterinary medicines.

Published 26 November 2014