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Article L1340-5 of the French Public Health Code

Manufacturers, importers, downstream users or distributors shall declare to the bodies responsible for toxicovigilance any cases of human intoxication of which they are aware and which are induced by a substance or mixture for which they have transmitted information pursuant to articles L. 1341-1 and L. 1342-1, and shall keep the information in their possession.

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Article L1340-6 of the French Public Health Code

The conditions for the application of this chapter are determined by decree in the Conseil d’Etat, in particular : 1° The organisation of the toxicovigilance system ; 2° The conditions under which the confidentiality with regard to third parties of information covered by medical secrecy or industrial secrecy transmitted pursuant to articles L. 1340-4 and L. 1340-5 is preserved; 3° The conditions for sharing information between the bodies responsible for…

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