Subsection 1: General authorisation conditions.

The provisions of this section apply to the activities mentioned in article L. 4211-8 relating to the preparation, storage, distribution, transfer, import or export of gene therapy preparations and to those mentioned in article L. 4211-9 relating to the preparation, storage, distribution, transfer, import or export of xenogenic cell therapy preparations. The authorisations provided for in articles L. 4211-8 and L. 4211-9 may relate to one or more of the…

Articles R. 1243-4 to R. 1243-10 and R. 1243-12 to R. 1243-14 are applicable to establishments or organisations carrying out the activities of preparation, storage, distribution or transfer of gene therapy preparations and xenogenic cell therapy preparations, with the exception, for activities relating to gene therapy preparations, of the provisions concerning the Agence de la biomédecine.

Applicant establishments or organisations must have : 1° Premises fitted out, arranged and maintained in accordance with the rules of good practice referred to in Article L. 5121-5 and, where applicable, in accordance with the containment requirements adopted pursuant to Article L. 532-1 of the Environmental Code; 2° Staff whose skills and qualifications comply with these rules of good practice; 3° Equipment complying with these rules of good practice, making…

The provisions of articles R. 1243-21 to R. 1243-23, R. 1243-25, first paragraph, R. 1243-27 to R. 1243-28 are applicable to establishments or organisations carrying out the activities mentioned in article R. 4211-16, with the exception, for gene therapy preparations, of the provisions concerning the Agence de la biomédecine. For the application of these articles, the authorisation for establishments or organisations which prepare, store, distribute and sell gene therapy preparations…

An establishment or an authorised body may transfer gene therapy preparations or xenogenic cell therapy preparations to another establishment or authorised body with a view to their preparation, storage and distribution by this second establishment or body. When transferred for distribution, the gene therapy preparations or xenogenic cell therapy preparations must comply with the rules of good practice provided for in Article L. 5121-5 and the requirements mentioned in the…

The application for authorisation or renewal of authorisation to carry out the activities of importing or exporting gene therapy preparations or xenogenic cell therapy preparations must be sent with a dossier to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by registered post with acknowledgement of receipt. The dossier shall include the information mentioned in Article R. 1243-4 and an attestation that…