Section 17: Conditions for authorisation of individually prepared advanced therapy medicinal products

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…

The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within a maximum of one hundred and twenty days from the date of receipt of the complete application. If no decision has been taken by the end of this period, the application will be rejected. If the Director General of the Agence nationale de sécurité du médicament…

The authorisation may be subject to special conditions requiring the beneficiary of the authorisation to implement a plan for monitoring the efficacy and safety of the medicinal product, including the periodic collection of information concerning efficacy and adverse reactions and the transmission of this information to the Director General of the Agence nationale de sécurité du médicament et des produits de santé.

A request for authorisation must be submitted for any changes which have an impact on the quality, safety and efficacy of the medicinal product. This application must be accompanied by a technical dossier, the model for which is laid down by decision of the Director General of the National Agency for the Safety of Medicines and Health Products. The decision of the Director General of the Agency is taken within…

In the event of failure to comply with the legislative and regulatory requirements, the conditions for granting or monitoring the authorisation referred to in Articles R. 5121-212 and R. 5121-213, or where it appears, particularly following evaluation, that the benefit/risk balance of the medicinal product is not favourable or that the claimed therapeutic effect is lacking, or in the event of danger to public health, the authorisation may be suspended…

The Agence de la biomédecine is informed of the decisions taken in application of Article R. 5121-212.