Title II: Medicinal products for human use

For the purposes of this section, advanced therapy medicinal products prepared on an ad hoc basis mean the advanced therapy medicinal products mentioned in 17° of Article L. 5121-1. For the purposes of II of Article L. 4211-9-1, only advanced therapy medicinal products prepared on an ad hoc basis which are autologous, i.e. which come from the person him/herself, including when they meet the definition of combined advanced therapy medicinal…

I. – The application for authorisation of an individually prepared advanced therapy medicinal product is accompanied by a dossier, the content of which is laid down by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé and which includes : 1° The name of the medicinal product and its composition ; 2° A summary of the information relating to the product,…

The application for authorisation is deemed to be complete if, within one month of receipt, the Director General of the Agence nationale de sécurité du médicament et des produits de santé has not informed the applicant, by registered letter with acknowledgement of receipt, of the list of missing or incomplete documents. If the documents required to examine the application are missing or incomplete, the Director General of the Agency will…