Book II: Donation and use of human body parts and products

Authorisations are issued to the establishment and, where applicable, jointly to the associated establishment in accordance with article R. 1261-11, for a period of five years. Applications for renewal must be accompanied by the supporting documents referred to in article R. 1261-24 and the activity report referred to in article R. 1261-16. It is made under the same terms and conditions as the initial application.

The ministerial authority renews the authorisation on the basis of the information mentioned in article R. 1261-25 and the establishment’s internal control report and, for activities that are subject to accreditation or that form part of an establishment’s research programme, the evaluation report by the Haut Conseil de l’évaluation de la recherche et de l’enseignement supérieur (High Council for the Evaluation of Research and Higher Education).

I.-The authorised establishment must be able to provide the administrative authority with the following information at any time: 1° The number of donations of human remains received each year; 2° The medical teaching activities and research projects undertaken; 3° The number and nature of consultations with ethical bodies; 4° Staff movements; 5° Staff training initiatives. II – The authority that issued the authorisation may also request information from the establishment…

I.-Any change to the information contained in the application for authorisation or renewal of authorisation must be brought to the attention of the establishment’s supervisory ministers without delay. The latter may request any additional information in order to ensure that the modification in question does not affect compliance with the applicable legislative and regulatory provisions. II.-In particular, the following must be notified to the establishment’s supervisory ministers: 1° Any change…

The structures receiving the bodies shall set up an information system shared with the ministerial authority for statistical, budgetary and financial purposes. Establishments authorised in application of the second paragraph of article L. 1261-1 shall be responsible for the computer register required to implement the missions defined in this chapter. An order by the Minister for Higher Education, after consultation with the Commission Nationale de l’Informatique et des Libertés, shall…

I.-In the event of an infringement of the applicable legislative and regulatory provisions, observed by the inspection bodies or the Inspectorate General to which the establishment reports or any other authority, the authorisation may be suspended or withdrawn by decision of the ministers responsible for the establishment. The ministers responsible may also, on the recommendation of the inspection bodies or the Inspectorate General to which the establishment reports, at any…