Section 2: Reporting cases of intoxication to toxicovigilance organisations

The occurrence of any toxic effect in humans following a single or repeated exposure to a mixture or substance, natural or synthetic, available on the market or present in the environment, constitutes a case of intoxication.

I.-Health professionals shall report without delay to the body responsible for toxicovigilance in their area any case of human intoxication that they observe and which presents one of the following seriousness criteria for the person intoxicated: 1° Death ; 2° Life-threatening; 3° Temporary or permanent functional impairment; 4° hospitalisation for more than twenty-four hours. II -Health professionals also declare : 1° Cases of intoxication covered by specialised monitoring systems defined…

The manufacturer, importer, downstream user or distributor of a substance or mixture shall declare without delay to the body responsible for toxicovigilance with territorial jurisdiction in accordance with article R. 1340-5 any case of human intoxication linked to this substance or mixture brought to its attention. This provision does not apply when the report comes under another regulated system of vigilance relating to the products defined in articles L. 5311-1,…

Health professionals and manufacturers, importers, downstream users and distributors of substances or mixtures are required to provide, at the request of the bodies responsible for toxicovigilance, regional health agencies or the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, any additional information they may have on cases they have reported and on cases that have been reported by a third party. The organisations that receive this…

The declarations and transmissions of information provided for in articles R. 1340-10 to R. 1340-12 and the use of this data are carried out in compliance with the provisions of articles R. 1340-6 and R. 1340-7. An order of the Minister for Health, issued after consultation with the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail and the Commission nationale de l’informatique…