French Public Health Code
In forceThe companies and organisations mentioned in article R. 5124-2 may not subcontract any of the activities defined in the same article or any of the operations mentioned in article R. 5124-40, subject to the exceptions mentioned below:
1° Manufacturers and importers of medicinal products mentioned in 1° of article L. 4211-1 and manufacturers and importers of generators, kits or precursors mentioned in 3° of the same article may subcontract part of the operations constituting manufacturing as defined in article R. 5124-2 to other manufacturers or importers of these medicinal products or products under a written contract which sets out their respective obligations, in accordance with the good practices provided for in article L. 5121-5 applicable to these operations;
2° Manufacturers and importers of medicinal products mentioned in 1° of article L. 4211-1, generators, kits or precursors mentioned in 3° of the same article and wholesale distributors of medicinal plants mentioned in 11° of article R. 5124-2, may, on condition that they justify this recourse to the Agence nationale de sécurité du médicament et des produits de santé, subcontract some of the quality control operations mentioned in article R. 5124-53 to a laboratory under a written contract which sets out their respective obligations, in accordance with the good practices provided for in Article L. 5121-5 applicable to these operations; in this case, the manufacturer or importer must inform the National Agency for the Safety of Medicines and Health Products so that the Agency can check that the subcontracting laboratory has sufficient competence and resources;
3° Manufacturers of medicinal products mentioned in 1° of Article L. 4211-1 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. 5121-5, their respective obligations and specifies the conditions of transport and intermediate storage of these raw materials;
4° Operators of medicinal products other than those intended to be tested on humans, generators, kits and precursors mentioned in 3° of Article L. 4211-1 may subcontract to a third party all or part of the operations constituting pharmacovigilance within the framework of a written contract which sets out, in accordance with the good practices provided for in Article R. 5121-179, their respective obligations. The implementation of this subcontracting does not release the operator from its obligations in terms of pharmacovigilance, for which it must retain control and pharmaceutical responsibility, in accordance with the provisions of article L. 5121-24 and articles R. 5121-162 to R. 5121-178.
5° They may also subcontract to a third party, under a written contract, the setting up and management of the emergency call centre or any equivalent system allowing direct contact mentioned in III of article R. 5124-49-1.
6° Operators of medicinal products other than those intended to be tested on humans, generators, kits and precursors mentioned in 3° of article L. 4211-1 may subcontract to a third party all or part of the operations constituting advertising or medical information within the framework of a written contract which sets out their respective obligations. Subcontracting does not release the operator from his obligations in terms of advertising or medical information, for which he must retain pharmaceutical control and responsibility.
The subcontracting operations mentioned in 1° to 6° and the reasons for them are summarised in the annual statement mentioned in article R. 5124-46.
