For the purposes of this Title, the definitions of the terms used are those set out in Article 2 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures.
The purpose of toxicovigilance is to monitor and assess the acute or chronic toxic effects on humans of exposure to an article, mixture or substance, whether natural or synthetic, available on the market or present in the environment, with a view to taking warning and preventive action. This chapter applies subject to the provisions relating to other vigilance systems regulated by this Code.
Healthcare professionals report cases of human intoxication caused by any substance, mixture or article of which they are aware to the bodies responsible for toxicovigilance.
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.
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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182, rue de Rivoli
75001, Paris France
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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