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Article R1340-7 of the French Public Health Code

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…

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Article R1340-8 of the French Public Health Code

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.

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Article R1340-10 of the French Public Health Code

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…

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Article R1340-11 of the French Public Health Code

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,…

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Article R1340-12 of the French Public Health Code

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…

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Article R1340-13 of the French Public Health Code

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…

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Article R1341-2 of the French Public Health Code

The information sent pursuant to Article L. 1341-1 to the bodies responsible for toxicovigilance and to the body mentioned in Article L. 4411-4 of the Labour Code, at their request, includes : 1° The existing name or names of the substance or mixture in question ; 2° The qualitative and quantitative composition of the mixture; where the mixture comprises one or more mixtures, the composition of which is not known…

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Article R1341-3 of the French Public Health Code

If the manufacturer, importer or downstream user of a substance or mixture is unable to provide all or part of the information referred to in Article R. 1341-2 within the time allowed, he shall inform the requesting body of the name of the natural or legal person who is able to do so.

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Article R1341-4 of the French Public Health Code

If the manufacturer, importer or downstream user wishes to contest the request made to him, he shall refer the matter to the Minister for Health and send a copy of his appeal to the requesting body. This appeal must be lodged before the expiry of the deadline set by the applicant for providing the information. The Minister responsible for health takes a decision and notifies the manufacturer, importer or downstream…

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