Title IV: Tissues, cells and products

The provisions of this sub-section apply to organisations carrying out the conservation and preparation for scientific purposes of tissues and cells from the human body and their derivatives when these activities are carried out for the needs of their own research programmes, whatever the purpose for which the sample was taken. The activities mentioned in the previous paragraph include the creation and use of collections of human biological samples as…

Where the activities referred to in article R. 1243-49 are carried out in separate locations, the organisation may submit several declarations, determining the scope covered by each of them.

The declaration is made up of a letter signed by the legal representative of the applicant organisation and a supporting file, entered using a teleservice. The letter describes the activity and certifies that the signatory has approved the supporting file. It is sent via the teleservice to the Minister for Research and, where applicable, to the Director General of the Regional Health Agency. The supporting dossier will only be taken…

The dossier is deemed to be complete if, within one month of receipt, the Minister responsible for research or, where applicable, the Director General of the regional health agency, has not informed the organisation of the missing or incomplete information and indicated the deadline for providing it. These authorities inform each other of the requests for additional information that they send to the reporting body and of the replies received….

Within two months of the date on which the dossier is deemed to be complete, the Minister for Research and, where applicable, the Director General of the Regional Health Agency may, in the cases provided for in Article L. 1243-3, object to the organisation carrying out the activities covered by the declaration. In the absence of notification of the decision to object within this period, the organisation may carry out…

Within the scope of the declaration, organisations must be able to provide the following information at any time: 1° The nature and number of samples held; 2° The characteristics of the samples held; 3° The origin of the samples and how they were obtained; 4° The sample preparation procedures; 5° The research project; 6° Depending on the cases provided for in Article L. 1211-2, details of consent or lack of…

Any change in the information contained in the declaration file that is likely to result in a substantial change in the conditions under which the declared activities are carried out, in particular a change in the person or persons scientifically responsible for the declared activities, a change in the nature of the elements and products prepared or conserved, their origin and the way in which they are obtained or the…

The Minister for Research may at any time suspend or prohibit the pursuit of activities that no longer meet the requirements set out in Article L. 1243-3. When the organisation is a health establishment, the decision to suspend or prohibit is taken jointly by the Minister for Research and the Director General of the Regional Health Agency. Before any decision to suspend or ban is taken, the organisation is given…