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(1).
(2) Schedule 2 (the manufacture of veterinary medicinal products) has effect.
(3) “Manufacture” includes any part of the manufacture of a veterinary medicinal product until the finished product is ready for sale in its final form as specified in the marketing authorisation but does not include the manufacture of an ingredient or breaking open the package of a veterinary medicinal product(2).
If the manufacture is carried out in the United Kingdom the manufacturer must hold a manufacturing authorisation for that type of product granted by the Secretary of State.
For provisions on breaking open packages see regulation 7(3).