Subsection 7: Manufacture and import of veterinary medicinal products.

Manufacturers of veterinary medicinal products mentioned in 1° of article R. 5142-1 must justify, at all times, that all the products they use, manufacture and deliver comply with the characteristics to which they must conform and that the necessary controls have been carried out. Manufacturers of veterinary medicinal products which are the subject of a marketing authorisation referred to in article L. 5141-5 or a registration referred to in article…

Each batch of veterinary medicinal products benefiting from a marketing authorisation referred to in article L. 5141-5 or a registration referred to in article L. 5141-9 is subject to control of the finished product when imported : 1° From a State which is not a member of the European Union and which is not a party to the Agreement on the European Economic Area ; 2° Or from another Member…

For each batch of medicinal products referred to in articles R. 5142-45 and R. 5142-46, the pharmacist or veterinarian responsible shall release the batches and certify that each manufacturing batch complies with the provisions of the aforementioned articles on a register provided for this purpose or by any appropriate system which does not allow any modification of the data it contains after validation of their registration.

A manufacturer and importer of veterinary medicinal products mentioned in 1° and 2° of article R. 5142-1 has one or more quality control departments. This department or these departments are placed under the authority of a suitably qualified person who is hierarchically independent of the other heads of department. The quality control department has one or more control laboratories with sufficient staff and equipment to carry out the necessary checks…

A veterinary pharmaceutical establishment which manufactures medicinal products mentioned in 1° of article R. 5142-1 has a documentation system comprising specifications, manufacturing formulae, procedures and statements, reports and records, covering the various operations which it carries out. For veterinary medicinal products other than those subject to clinical trials, the documents relating to each batch are kept by the veterinary pharmaceutical establishment which manufactures it, for at least one year after…