Title II: Research involving the human person

The issue of the site authorisation provided for in the second paragraph of Article L. 1121-13 is subject to compliance with the following conditions: 1° The possibility of ensuring appropriate supervision of persons undergoing research and, in the event of an emergency, emergency care and immediate transfer to an appropriate care service; 2° Where appropriate, a number of beds commensurate with the planned activities; 3° An organisation to ensure the…

The operations mentioned in the fourth paragraph of Article L. 1121-13 may only be carried out in the places governed by this section when the research envisaged does not allow these operations to be carried out in a pharmaceutical establishment authorised under Article L. 5124-1. The corresponding categories of research are defined by order of the Minister for Health issued on a proposal from the Director General of the Agence…

The application for authorisation is sent to the Director General of the Regional Health Agency, or to the Minister of Defence when the research is carried out in places under his authority, who will acknowledge receipt. It must include the following information 1° The name, position and duties of the applicant ; 2° The name, address and location of the research site; 3° The nature of the searches envisaged; 4°…

The authorisation referred to in article L. 1121-13 is issued after an investigation by a public health medical inspector or a regional health agency inspector qualified as a medical doctor and, where the research involves the use of medicinal products or sterile medical devices, a public health pharmacist inspector or a regional health agency inspector qualified as a pharmacist. The Minister of Defence is notified in advance of their visit…

Any change relating to the items listed in article R. 1121-12 requires a new authorisation to be issued, which must be the subject of a complete application in the forms provided for in article R. 1121-12, accompanied by the appropriate supporting documents. If the administration remains silent for more than two months from the date of receipt of the new application, it is deemed to have granted authorisation, unless this…

The authorisation may be withdrawn or suspended by the authority that issued it if the layout, equipment, hygiene, maintenance or operating conditions are no longer appropriate to the nature of the research or compatible with the safety requirements of the persons involved, after the authorisation holder has been given the opportunity to present its observations. In urgent cases, the authority that issued the authorisation may suspend it without any prior…