Title IV: Veterinary medicinal products

When the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail notifies the holder of the parallel import authorisation for a proprietary veterinary medicinal product of a change to the marketing authorisation for the proprietary veterinary medicinal product authorised in France, this change is reproduced by the holder of the parallel import authorisation in the summary of product characteristics, the package leaflet and…

The holder of the parallel import authorisation is responsible for placing the product on the market and, in this capacity, ensures that the provisions of this Title are complied with, in particular those relating to possession and supply referred to in Article R. 5141-112, labelling referred to in Articles R. 5141-73 to R. 5141-75, and the package leaflet referred to in Articles R. 5141-76 to R. 5141-78 and, with regard…

The holder of a parallel import authorisation for a proprietary veterinary medicinal product shall immediately inform the marketing authorisation holder in the country of origin of any serious adverse reaction, within the meaning of Article R. 5141-92, concerning the imported proprietary medicinal product, as soon as he is aware of it.

For veterinary medicinal products with a parallel import authorisation as provided for in Article R. 5141-123-12, customs officers check the corresponding parallel import authorisation number on the packaging. If the parallel import authorisation number does not appear on the packaging at the time of import, the copy of the parallel import authorisation is presented to the customs officers during the inspection.

The provisions relating to the import and export of veterinary medicinal products apply : 1° to medicinal products classified as narcotics or to which the narcotics regulations apply in whole or in part ; 2° Medicinal products classified as psychotropic. However, these medicinal products remain subject to the specific provisions relating to them respectively, which are set out in articles R. 5132-78, R. 5132-27 and R. 5132-91.

The authorisation provided for in Article L. 5141-10 is issued by the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail.

The certificate accompanying medicated feedingstuffs manufactured in another Member State of the European Union or party to the Agreement on the European Economic Area when they are imported corresponds to a model laid down by decision of the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail and which states: 1° The name or business name and address of the approved manufacturer and,…

Veterinarians providing the services referred to in Article L. 5141-15 who comply with the provisions of Article L. 241-3 of the Rural and Maritime Fishing Code may use in France veterinary medicinal products other than immunological medicinal products which have been granted a marketing authorisation in the Member State in which they practise when these medicinal products are not authorised in France, subject to the following conditions: 1° They must…

The veterinarian registers the medicinal products referred to in the first paragraph of article R. 5141-126 using any recording system that allows immediate presentation at the request of the control authorities and does not allow any modification of the data after validation of the registration. These records are kept for five years and include the following information: -the name of the veterinary medicinal product and the batch number; -the date…

The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, at the request of a veterinary pharmaceutical establishment exporting a veterinary medicinal product : 1° Certify that this establishment holds the authorisation provided for in Article L. 5142-2; 2° Certify that the establishment which manufactures the exported veterinary medicinal product holds the authorisation provided for in Article L. 5142-2 and that it is…