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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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Article R1341-7 of the French Public Health Code

The body mentioned in article L. 4411-4 of the Labour Code and the bodies responsible for toxicovigilance which have received information pursuant to article R. 1341-2 of this Code shall ensure that it is stored, used and transmitted in accordance with the provisions of articles R. 1340-6 and R. 1340-7. In the event of intoxication, personnel designated within the regional health agencies and qualified as doctors, pharmacists or engineers may…

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Article R1341-8 of the French Public Health Code

The body mentioned in Article L. 4411-4 of the Labour Code, the bodies responsible for toxicovigilance, the body responsible for managing the information system mentioned in Article R. 1340-6, the Agence nationale de santé publique, 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, the regional health agencies and the State departments responsible…

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Article R1341-9 of the French Public Health Code

The body referred to in article L. 4411-4 of the Labour Code and the bodies responsible for toxicovigilance ensure that information relating to substances and mixtures is transmitted and updated in accordance with articles R. 1341-2 and R. 1342-13 to the body responsible for managing the information system referred to in article R. 1340-6.

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Article R1341-10 of the French Public Health Code

The provisions of articles R. 1341-2 to R. 1341-9 do not apply : 1° Medicinal products for human or veterinary use defined in articles L. 5111-1 and L. 5141-2 ; 2° Cosmetic products, as defined in article L. 5131-1 ; 3° (Repealed) ; 4° (Repealed) ; 5° Foodstuffs and their components; 6° Animal feed and its components; 7° Waste governed by Title IV of Book V of the Environment Code.

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