Chapter III: Inspection

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.