French Public Health Code
In forceThe following definitions apply
1° Manufacturer: a company comprising one or more veterinary pharmaceutical establishments engaged in the manufacture of veterinary medicinal products other than medicated feedingstuffs, with a view to their wholesale sale, free transfer or use in clinical trials on animals. Manufacturing includes operations relating to the purchase of raw materials and packaging items, production operations, quality control, batch release, as well as the corresponding storage operations, as defined by the good practices provided for in article L. 5142-3 applicable to this activity. For medicinal products subject to clinical trials, the monitoring of these medicinal products and, if necessary, withdrawal operations are carried out by the manufacturer, under the responsibility of the sponsor mentioned in article R. 5141-3 ;
2° Importer, the company comprising one or more veterinary pharmaceutical establishments engaged, with a view to their wholesale sale, their transfer free of charge or their use in clinical trials on animals, in the import, storage, quality control and release of batches of veterinary medicinal products, other than medicated feedingstuffs, from :
a) States that are not members of the European Union or parties to the Agreement on the European Economic Area ;
b) Or from other Member States of the European Union or parties to the Agreement on the European Economic Area when these veterinary medicinal products have been manufactured by an establishment not authorised under Article 44 of Directive 2001/82/EC of 6 November 2001 on the Community code relating to veterinary medicinal products. For medicinal products subject to clinical trials, the monitoring operations and, if necessary, their withdrawal are carried out by the importer, under the responsibility of the sponsor mentioned in article R. 5141-3 ;
3° Operator, the company comprising one or more veterinary pharmaceutical establishments engaged in the operation of veterinary medicinal products other than those subject to clinical trials and medicated feedingstuffs. Exploitation includes wholesale sales or sales free of charge, advertising, information, pharmacovigilance, batch monitoring and, where applicable, withdrawal, as well as, where applicable, the corresponding storage operations. The operation is carried out either by the holder of the marketing authorisation referred to in Article L. 5141-5, or of the registration referred to in Article L. 5141-9, or, on behalf of this holder, by another company, or by both, each carrying out in this case one or more categories of operations constituting the operation of the veterinary medicinal product;
4° Depository, the company comprising one or more veterinary pharmaceutical establishments carrying out, by order and on behalf of one or more operators, the storage of veterinary medicinal products which it does not own and their wholesale distribution in the state;
5° Wholesale distributor of veterinary medicinal products, the company comprising one or more veterinary pharmaceutical establishments engaged in the purchase of veterinary medicinal products other than those subject to clinical trials, their storage and their wholesale distribution as is;
6° A wholesale distributor specialising in exports: an undertaking comprising one or more veterinary pharmaceutical establishments engaged in the purchase of veterinary medicinal products other than those subject to clinical trials, their storage and their export as such;
7° Wholesale distributor of antiparasitic veterinary medicinal products intended for the external treatment of companion animals, the company comprising one or more veterinary pharmaceutical establishments engaged in the purchase and storage of those of these medicinal products falling within the scope of the derogation provided for in the last paragraph of article L. 5143-2, with a view to their wholesale distribution as such;
8° Distributor of veterinary medicinal products subject to clinical trials, the company comprising one or more veterinary pharmaceutical establishments carrying out, on behalf of one or more promoters defined in article R. 5141-3, the storage of veterinary medicinal products subject to clinical trials, manufactured or imported by companies defined in 1° or 2° of this article and their distribution as such;
9° Wholesale distributor of medicated premixes, a company comprising one or more veterinary pharmaceutical establishments engaged in the purchase and storage of medicated premixes and their wholesale distribution as is;
10° Wholesale distributor specialising in the export of medicated premixes, an undertaking comprising one or more veterinary pharmaceutical establishments engaged in the purchase and storage of medicated premixes for export as such;
11° Manufacturer of medicated feedingstuffs, a company comprising one or more veterinary pharmaceutical establishments engaged in the manufacture of medicated feedingstuffs with a view to their sale, free transfer or the performance of clinical trials on animals; this manufacture includes operations relating to the purchase of the medicated premix or premixes, packaging items, mixing, quality control, the corresponding storage operations, the corresponding controls, particularly with regard to homogeneity, as well as the monitoring of batches and, if necessary, their withdrawal.
For medicated feeds subject to clinical trials, distribution, monitoring of the said medicinal products and, if necessary, their withdrawal are carried out by the manufacturer, under the responsibility of the sponsor mentioned in article R. 5141-3 ;
12° Importer of medicated feedingstuffs, the company comprising one or more veterinary pharmaceutical establishments engaged, with a view to their sale, free transfer or the performance of clinical trials on animals, in the importation, storage, quality control of batches of medicated feedingstuffs and the monitoring and, if necessary, withdrawal of batches of medicated feedingstuffs from :
a) States that are not members of the European Union or parties to the Agreement on the European Economic Area ;
b) Or from other Member States of the European Union or parties to the Agreement on the European Economic Area when the medicated feedingstuffs have been manufactured by an establishment not authorised under Article 4 of Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the European Union. For medicated feedingstuffs subject to clinical trials, distribution, monitoring and, if necessary, withdrawal operations are carried out by the importer, under the responsibility of the sponsor mentioned in Article R. 5141-3 ;
13° Distributor of medicated feedingstuffs, the company comprising one or more veterinary pharmaceutical establishments engaged in the purchase and storage of medicated feedingstuffs other than those subject to clinical trials and their distribution as such;
14° Distributor for the export of medicated feed, the company comprising one or more veterinary pharmaceutical establishments engaged in the purchase and storage of medicated feed other than those subject to clinical trials and their export as such.
