Section 16: General conditions for authorisation of gene therapy preparations and xenogenic cell therapy preparations

The application for authorisation or renewal of authorisation provided for in 12° and 13° of Article L. 5121-1 shall be sent by registered post with acknowledgement of receipt or lodged against receipt with the Director General of the Agence nationale de sécurité du médicament et des produits de santé by the establishments and organisations authorised to carry out the activities mentioned in Article R. 4211-16 . The application must be…

Without prejudice to the provisions of Chapter III of Title III of Book V of the Environment Code, the provisions of Articles R. 1243-34 to R. 1243-38 are applicable to the conditions for authorisation of gene therapy preparations and xenogenic cell therapy preparations, with the exception, for gene therapy preparations, of obtaining the opinion of the Agence de la biomédecine provided for in Article R. 1243-34. For the application of…