Section 3: Competent authority.

The content, format and methods of presentation of the application for authorisation are defined by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé.

The competent authority shall notify the sponsor of the date of receipt of the dossier and the date on which, in the absence of express authorisation, the research is deemed to have been authorised. If the dossier is not complete, the competent authority will notify the sponsor of a list of the missing documents and set a deadline for submission, after which the sponsor will be deemed to have withdrawn…

If the research involving the human person has not begun within two years of authorisation, this authorisation lapses. However, if justification is provided before the expiry of this period, it may be extended by decision of the competent authority.

The sponsor informs the competent authority and the Committee for the Protection of Individuals without delay of the effective date of commencement of the research, corresponding to the date on which the consent is signed by the first person to take part in the research in France.

The sponsor shall inform the National Commission for Research Involving the Human Person and the National Agency for the Safety of Medicines and Health Products without delay of situations in which it has terminated the participation of an investigator or any other person involved in the research because of a serious or deliberately repeated deviation from the protocol, or a serious breach of the legislative and regulatory provisions in force…