Article L1338-5 of the French Public Health Code
November 8, 2023
Where necessary, the conditions for the application of this chapter shall be determined by decree in the Conseil d’Etat.
Where necessary, the conditions for the application of this chapter shall be determined by decree in the Conseil d’Etat.
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…
Manufacturers, importers or downstream users of any substance or mixture shall communicate, as soon as they receive a request to do so, to the bodies responsible for toxicovigilance or to any other competent body designated by regulation, the information necessary to prescribe preventive and curative measures, in particular in the event of a health emergency.
The conditions for the application of this chapter shall be determined by decree of the Conseil d’Etat, in particular: 1° The definition of the information to be transmitted to the bodies mentioned in article L. 1341-1 ; 2° The conditions under which the confidentiality with regard to third parties of information covered by industrial secrecy transmitted pursuant to the same article L. 1341-1 is preserved.
Importers or downstream users who place on the market mixtures classified as hazardous because of their health or physical effects shall draw up a single declaration in accordance with 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, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. This declaration is…
The procedures for applying the provisions of this chapter, in particular the persons who have access to the information declared pursuant to Article L. 1342-1, the conditions under which the confidentiality with regard to third parties of information covered by industrial secrecy is preserved and the conditions under which the marketing, advertising and use of dangerous substances and mixtures may, for public health reasons, be subject to prohibition, restriction or…
Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call us at +33 (0) 1 84 88 31 00 or send us an email.
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
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
Resources
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
Useful links
Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call +33 (0) 1 84 88 31 00 or send us an email.
All information exchanged through this website will be communicated to lawyers registered with a French Bar and will remain confidential.
