Division 1.3.2 Finished productF1

Information on the container-closure system for the finished product shall be given. The level of information required shall be determined by the route of administration of the veterinary medicinal product and the physical state (liquid, solid) of the dosage form.

Packaging materials shall comply with the requirements of the appropriate European Pharmacopoeia monograph. Where such a monograph does not exist reference may be made to the pharmacopoeia of a Member State. In the absence of such a monograph reference may be made to the Pharmacopoeia of a third country. In this case the suitability of this monograph shall be demonstrated.

In the absence of a pharmacopoeial monograph, a specification shall be proposed and justified for the packaging material.

Scientific data on the choice and suitability of the packaging material shall be presented.

For novel packaging materials in contact with the product, information on their composition, manufacture and safety shall be presented.

Specifications and, if appropriate, performance data shall be presented for any dosing or administration device supplied with the veterinary medicinal product.