Title I: Tasks and prerogatives

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…

I. – As part of their duties relating to the products mentioned in article L. 5311-1 and after giving prior notice of their visit to the Minister for Defence, the inspectors from the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products), authorised by the Minister for Defence under the conditions set out in articles R. 2311-1…

The Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) carries out inspections on file or on site at least once every two years, under the conditions laid down in this chapter, in each establishment and organisation authorised in application of Article L. 1243-2 , including when they have an authorisation for import activity under Article R….

In carrying out checks on the application of the provisions of Title II of Book I of Part I and the regulatory measures taken for its application falling within the remit of the Agence nationale de sécurité du médicament et des produits de santé defined in Article L. 5311-1, the Agency’s inspectors have access to the file provided for in Article L. 1121-16.