Part One: General health protection

Any sponsor based in France who plans to carry out research involving the human person in a non-EU country may submit its project to a committee for the protection of individuals. The Committee for the Protection of Individuals gives its opinion on the conditions for the validity of the research with regard to article L. 1121-2 and I of article L. 1123-7.

When the National Agency for the Safety of Medicines and Health Products, the High Authority for Health, the Minister for Health or the European Medicines Agency refers a non-interventional research project involving a medicinal product which has been granted a marketing authorisation to the Committee for the Protection of Individuals for an opinion, it shall give the opinion referred to in Article L. 1123-7 solely with regard to the requirements…

No one may carry out any research mentioned in 1° of Article L. 1121-1 without authorisation from the competent authority issued within a period set by regulation. If the competent authority informs the sponsor in a letter, stating the reasons, that it has objections to the implementation of the research, the sponsor may modify the content of its research project and submit this new request to the competent authority. This…

After the start of the research, any substantial modification of the research on the initiative of the sponsor must obtain a favourable opinion from the Committee prior to its implementation and, in the case of research mentioned in 1° of Article L. 1121-1, authorisation from the competent authority. In this case, the Committee ensures that a new consent is obtained from the persons participating in the research if this is…

For each type of research involving the human person, the investigator records the adverse events or abnormal analysis results defined in the protocol as decisive for the evaluation of safety, keeps a documentary record of them and notifies them to the sponsor. The notification procedures are defined by decree. It informs the sponsor of all serious adverse events occurring in participants, unless the protocol states otherwise. The sponsor shall notify…

The competent authority may, at any time, ask the sponsor for additional information about the research. If there is a risk to public health or if the sponsor fails to respond, or if the competent authority considers that the conditions under which the research is being carried out no longer correspond to the conditions indicated in the application for authorisation referred to in Article L. 1123-8 or do not comply…

I.-The competent authority for the research involving the human person provided for in article L. 1121-1 is the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products). II-The Agency makes its decision with regard to the safety of persons who take part in the research referred to in 1° of article L. 1121-1, by considering : 1°…

If the research is to be carried out in one or more public or private establishments, the sponsor must inform the director(s) of these establishments before the research is carried out.

The procedures for applying the provisions of this chapter are determined by decree in the Conseil d’Etat, and in particular : 1° The composition and conditions of approval, financing, operation and appointment of the members of the Committees for the Protection of Individuals, as well as the nature of the information that must be communicated to them by the sponsor and on which they are called to give their opinion;…