Article R1245-8 of the French Public Health Code
November 5, 2023
Any modification of the information contained in the initial import and export authorisation application dossier, concerning the nature or origin of the products, as well as the substantial modifications mentioned in 4° of Article R. 1243-7, are subject to authorisation issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. The application for modification is submitted and examined under the same conditions…
