The Veterinary Medicines Regulations 2005

Manufacture of veterinary medicinal products

5.—(1) The holder of a marketing authorisation must ensure that every stage in the manufacture of the veterinary medicinal product is carried out by the manufacturer specified in the marketing authorisation (who must, if the manufacture is carried out in the United Kingdom, hold a manufacturing authorisation for that type of product granted by the Secretary of State) and failure to do so is an offence.

(2) Schedule 2 (provisions relating to the manufacture of veterinary medicinal products) has effect.

(3) “Manufacture” includes any part of the manufacture of a veterinary medicinal product and any ingredient of the product until the finished product is packaged, labelled and ready for sale in its final form but does not include the manufacture of starting materials intended for use as an active substance in a veterinary medicinal product.

(4) Notwithstanding the above—

(a) the holder of a wholesale dealer’s authorisation (in accordance with regulation 13) or a suitably qualified person (in accordance with paragraph 9 of Schedule 3) may break open packages (other than the immediate packaging of the veterinary medicinal product);

(b) a pharmacist may break open any package other than the immediate packaging of injectable products; and

(c) a veterinary surgeon may break open any package.