French Public Health Code
In forceI.-The application for authorisation provided for in Article L. 1243-2 shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by the legal entity requesting the authorisation, by any means that provides a date certain of receipt. This application specifies, for each establishment or organisation and, where applicable, for each of the sites of this establishment, the activities for which authorisation is sought and, for each activity, the tissues, their derivatives, the cells or the cell therapy preparations concerned.
II-This application may only be examined if it is accompanied by a supporting dossier, the form and content of which are specified by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, taken after obtaining the opinion of the Agence de la biomédecine and published on the website of the Agence nationale de sécurité du médicament et des produits de santé.
This file includes :
1° Information on the premises, equipment and materials, staff, procedures and agreements with third parties;
2° Information on the removal of tissues and cells;
3° Information on the preparation process used;
4° Information on the finished product;
5° List of products and materials coming into contact with tissues, their derivatives, cells and cell therapy preparations;
6° Preclinical data, depending on the product which is the subject of the application, as well as clinical data, including the results of clinical trials and the therapeutic indications claimed;
7° Where applicable, information relating to the implementation of the procedures mentioned in Article R. 1243-17 ;
8° Where the application comes from a health establishment, a copy of the letter and the accompanying acknowledgement of receipt, certifying that the Director(s) General of the Regional Health Agency(ies) responsible for the region in which the establishment's sites are located have been informed of the application for authorisation to carry out the activities referred to in Article R. 1243-1, as well as, where applicable, a copy of any letter indicating the Regional Health Agency's observations on the implementation of such activities;
9° Where the establishment or organisation applies for the specific authorisation provided for in I of Article R. 1243-3-1 :
a) A list of the categories of tissues and their derivatives that will be the subject of the planned agreements, the corresponding therapeutic indications and the clinical justification for these agreements;
b) The storage and provision arrangements that will be required, in particular the minimum qualification requirements for the staff involved in these activities within the contracting establishment, as well as the essential conditions relating to the premises, access to them and the equipment;
c) A description of the means implemented to ensure the traceability of the tissues and their derivatives, the storage of which is planned;
d) A model agreement.
III -The application 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 any means giving a date certain on receipt, of the information that is missing or incomplete and stating the time limit for providing it.
