Chapter III: Inspection

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…

In all cases where the Agency’s inspectors identify an infringement likely to result in criminal proceedings, the Agency’s Director General will forward the report(s) referred to in Article L. 5411-2 to the competent public prosecutor.

In order to monitor the application of the laws, regulations and standards applicable to the activities and products referred to in Article L. 5311-1, and subject to the specific provisions laid down by this Code or by European regulations, the inspectors of the Agence nationale de sécurité du médicament et des produits de santé may carry out inspections of establishments and premises where activities relating to the products referred to…

Within ninety days of the inspection of a pharmaceutical establishment referred to in article R. 5124-2, a certificate of compliance with good practice is issued to the pharmacist in charge if, at the date of the inspection, the establishment complies with the good manufacturing or wholesale distribution practices referred to in article L. 5121-5. This certificate may be issued for all or part of the activities inspected. It may not…

The certificate of compliance with good practice relating to raw materials for pharmaceutical use is issued in accordance with Articles R. 5138-3 to R. 5138-6. When the inspection reveals serious breaches of the good practices mentioned in article L. 5138-3 by an establishment holding the certificate mentioned in the first paragraph, the Agence nationale de sécurité du médicament et des produits de santé may withdraw it or shorten its duration…

The inspectors of the Agence nationale de sécurité du médicament et des produits de santé are authorised by the Minister for Defence to work in the pharmaceutical establishments of the central pharmacy of the armed forces or the medical supply establishments of the armed forces health service, in accordance with the conditions set out in the decree referred to in the last paragraph of article 413-9 of the Criminal Code….

The Agence nationale de sécurité du médicament et des produits de santé carries out an inspection of each blood establishment at least once every two years. The purpose of these inspections is to ensure that the establishment’s blood transfusion activities comply with the good practices referred to in article L. 1222-12 and with the operating and equipment standards applicable to them. As part of these inspections, the Agency may also…