Any manufacturer, importer or distributor of excipients as defined by Article L. 5138-2 who carries on business without having made a declaration to the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) in accordance with the conditions set out in Article L. 5138-1 is liable to one year’s imprisonment and a fine of €75,000.