French Public Health Code
In forceThe establishments mentioned in article R. 5142-1 may not subcontract any of the activities defined in the same article, subject to the exceptions mentioned below:
1° Manufacturers of veterinary medicinal products mentioned in 1° of article R. 5142-1 may subcontract part of the manufacturing operations to other manufacturers of these veterinary medicinal products under a written contract which sets out their respective obligations, in accordance with the good practices provided for in article L. 5142-3 applicable to these operations;
2° Manufacturers and importers of veterinary medicinal products mentioned in 1° and 2° of article R. 5142-1 may, in exceptional cases and on condition that they justify this recourse to the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail, entrust some of the quality control operations mentioned in article R. 5142-47 to a laboratory under a written contract which sets out their respective obligations, in accordance with the good practices provided for in Article L. 5142-3 applicable to these operations; in these cases, the manufacturer or importer must inform the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail so that the latter can check that the subcontracted laboratory has sufficient competence and resources;
3° Manufacturers of veterinary medicinal products mentioned in 1° of Article R. 5142-1 may subcontract to the manufacturer of a raw material for pharmaceutical use used in the composition of their medicinal products all or part of the controls of this raw material as provided for in the marketing authorisation or registration dossier, with the exception of its identification, in a written contract which sets out, in accordance with the good practices provided for in Article L. 5142-3, their respective obligations and specifies the conditions of transport and intermediate storage of these raw materials;
4° The manufacturers of medicated feedingstuffs mentioned in 11° of article R. 5142-1 may subcontract the entire manufacture of certain medicated feedingstuffs to other manufacturers of medicated feedingstuffs. They may also entrust certain quality control operations to a laboratory. Subcontracting or the provision of control services are carried out within the framework of a written contract which sets out their respective obligations, in accordance with the good practices provided for in Article L. 5142-3 applicable to these operations;
5° Operators of veterinary medicinal products mentioned in 3° of article R. 5142-1 may subcontract all or part of the pharmacovigilance operations mentioned in articles R. 5141-104 and R. 5141-105:
-either to another veterinary pharmaceutical establishment established in France;
-or to an organisation established in another Member State of the European Union and commissioned by the marketing authorisation holder to carry out these operations.
This subcontracting is carried out within the framework of a written contract which sets out the respective obligations of the operator and the subcontractor, in accordance with the good practices provided for in Article L. 5142-3 applicable to these operations. The operator informs the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (French National Agency for Food, Environmental and Occupational Health Safety) so that the latter can check that the subcontractor has sufficient skills and resources.
