Chapter III: Reagents

Any manufacturer, importer or distributor of reagents is liable to a fine of the fifth class: 1° Placing a reagent on the market, whether free of charge or against payment, without having registered it with the Agence nationale de sécurité du médicament et des produits de santé; 2° Failing to notify the Agence nationale de sécurité du médicament et des produits de santé of any change affecting the elements of…

Failure by a manufacturer, importer or distributor of reagents to comply with the obligation to inform the user under the conditions defined in articles R. 5133-1 to R. 5133-3 is punishable by a fifth-class fine.

A manufacturer, importer or distributor who has registered a reagent is liable to a fine of the fifth class for failing to forward to the Agence nationale de sécurité du médicament et des produits de santé any information on unexpected or undesirable effects, or on shortcomings or errors, likely to be due to this reagent and of which he has become aware.

Repeated offences under this chapter are punishable in accordance witharticle 132-11 of the French Penal Code.