Chapter V: Special provisions for certain types of research

Research involving the following products is subject to express authorisation from the Director General of the Agence nationale de sécurité du médicament et des produits de santé: 1° Organs and tissues of human origin and labile blood products ; 2° Cells of human origin and the cell therapy preparations referred to in Article L. 1243-1 ; 3° Xenogenic cell therapy preparations mentioned in 13° of Article L. 5121-1; 4° Medical…

The application for authorisation relating to the research mentioned in 1° of Article L. 1121-1 concerning the products mentioned in Article R. 1125-7 is sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, who decides on the admissibility of the application, ensuring that the application contains all the information. He will acknowledge receipt to the sponsor and notify him of the…

When the application concerns the organs and tissues of human or animal origin mentioned in 1° and 6° of Article R. 1125-7, and the cell therapy preparations mentioned in 2° of Article R. 1125-7 as well as the xenogenic cell therapy preparations mentioned in 3° of Article R. 1125-7, the Director General of the Agence nationale de sécurité du médicament et des produits de santé sends a copy of the…

The time limits within which the Director General of the Agence nationale de sécurité du médicament et des produits de santé must notify the applicant of his response are set as follows: 1° Sixty days from the date of receipt of the complete dossier for research involving the products mentioned in 4° and 5° of Article R. 1125-7; 2° Ninety days from the date of receipt of the complete dossier…

The Director General of the Agence nationale de sécurité du médicament et des produits de santé may notify the sponsor of any objections to the implementation of the research in a reasoned letter. He will inform the relevant personal data protection committee. It sets a deadline for the sponsor to submit its amended project. The sponsor may amend the content of his research project and send it to the Director…

Any substantial modification requires a new authorisation to be issued under the conditions set out in Article R. 1125-8. If the Director General of the Agence française de sécurité sanitaire does not respond to an application from the sponsor for a substantial amendment, this will be deemed to constitute a refusal of the application on expiry of a period of thirty-five days from receipt of all the information required concerning…

The provisions of articles R. 533-1 to R. 533-17 of the Environment Code are applicable to research involving products, other than medicinal products, composed in whole or in part of genetically modified organisms.

Annex II of Regulation (EC) 1223/2009 setting out the list of substances that may not be used in cosmetic products is applicable to the composition of cosmetic products used in research involving the human body.