Preliminary chapter: General provisions

The national toxicovigilance system comprises : 1° The Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail ; 2° The organisations responsible for toxicovigilance defined in article R. 1340-4 ; 3° The regional health agencies; 4° The National Public Health Agency; 5° The Agence nationale de sécurité sanitaire du médicament et des produits de santé; 6° Health professionals and manufacturers, importers, downstream users and distributors of substances…

The Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail is responsible for implementing the toxicovigilance system. It defines the guidelines, coordinates the actions of the various parties involved and participates in the scientific evaluation of the information collected. To this end: 1° It defines the operating procedures of the national toxicovigilance system as well as the missions and evaluation procedures of the organisations responsible for toxicovigilance;…

The Strategic Vigilance Committee of the organisations responsible for toxicovigilance issues an opinion on : 1° The general organisation of the vigilance activities of these bodies, as well as the guidelines and developments required in terms of monitoring, expertise and management of toxic risks, based in particular on the activity reports of the bodies responsible for toxicovigilance and the indicators contained therein; 2° The strategic orientations of the information system…

The bodies responsible for toxicovigilance include the poison control centres mentioned in article L. 6141-4 and the health establishments on a list drawn up by order of the Minister for Health on a proposal from the Director General of 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) after consultation with the Directors General of the…

The bodies responsible for toxicovigilance are responsible for : 1° To monitor, within their area of competence, in liaison with the regional health agencies, human intoxications falling within the scope of toxicovigilance as defined in article L. 1340-2. To this end, they gather all relevant information, in particular on the circumstances, causes and seriousness of intoxications; 2° Recording data relevant to toxicovigilance in the information system referred to in article…

The information system for poison control and toxicovigilance centres includes all data relating to cases of poisoning and data relating to substances and mixtures. This system ensures the secure exchange of data between the natural and legal persons mentioned in article R. 1340-1. The procedures for implementing and operating the information system, as well as the technical specifications of the devices designed to guarantee the transmission of information and the…

The data in the information system referred to in article R. 1340-6 are accessible, for the purposes of their respective missions and in compliance with the rules guaranteeing the confidentiality of information covered by medical or business secrecy: 1° To organisations responsible for toxicovigilance ; 1° bis To the Institut national de recherche et de sécurité pour la prévention des accidents du travail et des maladies professionnelles ; 2° The…

In order to carry out their duties, the bodies responsible for toxicovigilance have access, at their request, to anonymised data held by the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail and the Agence nationale de sécurité du médicament et des produits de santé as part of the vigilance systems relating to the products mentioned in articles L. 5311-1, L. 5141-1 and R. 1323-1.