Article R1245-13 of the French Public Health Code
The application for authorisation provided for in the second paragraph of II of Article L. 1245-5 shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by any means enabling its receipt to be dated, by an establishment or body already authorised under Article L. 1243-2. This request is accompanied by a letter from the applicant justifying the need to…