Article R4211-21 of the French Public Health Code
The application for authorisation or renewal of authorisation to carry out the activities of importing or exporting gene therapy preparations or xenogenic cell therapy preparations must be sent with a dossier to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by registered post with acknowledgement of receipt. The dossier shall include the information mentioned in Article R. 1243-4 and an attestation that…