Subsection 3: Inspectorate of the Agence de la biomédecine

Pursuant to Article L. 1418-2, the Agency may carry out inspections of legal entities and individuals holding the authorisations or approvals mentioned in Article L. 1418-1.

Appointment as an inspector of the Agency is the subject of a decision by the Director General.

The information gathered in the course of the inspection shall be the subject of a report sent by the inspector in charge of the inspection to the Director General of the Agency. This report is sent to the person who was inspected. The person may make comments within fifteen days. In the light of the shortcomings noted in the inspection report and these observations, the Director General may decide to…

In agreement with the Director General of the Agence nationale de sécurité du médicament et des produits de santé, the Director General of the Agency may decide to carry out a joint inspection, in particular when this concerns an establishment or body carrying out activities on the same site which have been authorised by both of these agencies in application of the legislative and regulatory provisions in force.