Manufacture and import

Manufacture of veterinary medicinal products shall only be carried out in possession of an authorization. Applications for manufacturing authorisation have to be submitted to IVMPalso in case of partial manufacture, including the quality control of the product.

If the marketing authorization holder of a veterinary medicinal product entrusts a contract manufacturing sitemanufacturing, while keeping certain responsibilities
of the production (e.g. qualification of the basic ingredients, batch qualification,
product release), for those a pharmaceutical manufacturing authorization should
also be asked.

The importation is also ranked as a manufacturing process, so the requirements
relating to the manufacturing should be applied for the authorization process
of that activity as well.

The holder of the manufacturing authorization has to apply for a permission in
case of manufacturing for exportation, too. The manufacturing must be carried
on according to the GMP requirements.

The applications for the manufacturing authorization should be submitted to the
IVMP in two copies. Data should be given according to the operative legislation.
Procedure fees are to be
paid in advance.