Title IV: Tissues, cells and products

Transfers carried out by an organisation in the following cases are not considered to be transfers within the meaning of this sub-section: 1° The organisation carries out research in collaboration with one or more other organisations under a contract which provides that these partners may only use the tissues, cells and their derivatives to carry out the research described in this contract and which determines the fate of the samples…

Where the activities referred to in article R. 1243-57 are carried out in separate locations, the organisation may submit several applications for authorisation, determining the scope covered by each application.

The application for authorisation consists of a letter signed by the legal representative of the applicant organisation and a supporting file, entered via a teleservice. The letter describes the activity and certifies that the signatory has approved the supporting documents. 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 application 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 applicant of the missing or incomplete information and indicated the deadline for providing it. These authorities inform each other of requests for additional information that they send to the applicant establishment or organisation.

The decision of the Minister for Research or, where applicable, the joint decision of the Minister for Research and the Director General of the Regional Health Agency is notified to the applicant within three months of the date on which the application is deemed to be complete. If there is no response within this period, this will be deemed to be an implicit rejection decision. The Minister responsible for research…

Authorisations are issued for a period of five years. Applications for renewal must be accompanied by the supporting documents mentioned in article R. 1243-60 and an activity report. It is made under the same terms and conditions as the initial application.

Authorised bodies 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° How the samples are prepared; 4° The origin of the samples and how they were obtained; 5° Depending on the cases provided for in Article L. 1211-2, details of consent or absence of opposition; 6° The contact details of the…

Any change to the information contained in the application for authorisation or renewal of authorisation is immediately brought to the attention of the Minister for Research and, where applicable, the Director General of the Regional Health Agency. The latter may request any additional information in order to ensure that the modification in question does not affect compliance with the legislative and regulatory provisions or the requirements mentioned in the second…

In the event of infringement of legislative and regulatory provisions or failure to comply with the requirements mentioned in the second paragraph of Article R. 1243-62, the authorisation may be suspended or withdrawn by the Minister responsible for research. When the organisation is a health establishment, the decision to suspend or withdraw authorisation is taken jointly by the Minister for Research and the Director General of the Regional Health Agency….