Chapter III: Reagents

The leaflet accompanying each registered reagent includes the following information in French for the user: 1° The name of the reagent, together with an indication of its diagnostic and therapeutic purpose; 2° The name and address of the manufacturer, distributor and, where applicable, importer; 3° The nature of the main component(s) and, where applicable, the composition of the calibration solutions required for use of the reagent; 4° Relevant information on…

The immediate packaging and the outer packaging, within the meaning of Article R. 5121-1, include the following information written in French for the user: 1° The name of the reagent ; 2° The name and address of the distributor ; 3° The indication “in vitro use”; 4° If necessary, the indication “danger”; 5° Storage conditions; 6° The expiry date; 7° Manufacturing batch number.

The content of the information provided for in articles R. 5133-1 and R. 5133-2 for reagents requiring special precautions for use may be specified, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order of the Minister for Health.