Book III: National Agency for the Safety of Medicines and Health Products

Designation as an inspector of the Agence nationale de sécurité du médicament et des produits de santé, as provided for in Article L. 5313-1, is the subject of a decision by the Director General. The list of designated inspectors is published and regularly updated on the Agency’s website.

The Agency’s inspectors shall carry out inspections as decided by the Agency’s Director General, who shall issue a letter of assignment to the inspector in charge of the investigation. This letter specifies the establishment or location to be inspected and the name(s) of the Agency’s inspector(s).

The information gathered in the course of the inspection mission is the subject of a report sent by the inspector in charge of the mission to the Director General of the Agency. The form and content of this report are defined by the Director General of the Agency and, in the case of medicinal products, in cooperation with the European Medicines Agency. This report is sent to the pharmacist in…

I.-When a reasoned request is made to this end, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall send, by any means, the report mentioned in Article R. 5313-3 to the European authorities responsible for the safety of the health products mentioned in Article L. 5311-1. This report shall be sent under conditions guaranteeing the confidentiality of sensitive information. The Director General…