Section 2: Obligation to report.

Manufacturers, importers and distributors of reagents, as well as users, and in particular medical biology analysis laboratories, shall transmit 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 these reagents and of which they are aware.

Where it appears that a reagent presents risks to public health, including as a result of non-compliance with the rules laid down in this chapter, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall notify the manufacturer, importer or distributor, informing it of his intentions and inviting it to submit its observations within a period which may not exceed one month. In…