Article R1123-62 of the French Public Health Code
Urgent safety measures taken in accordance with the fourth paragraph of Article L. 1123-10, consisting of stopping the research or taking immediate measures, are followed, depending on the case, either by a declaration concerning the end of the research or by an application for substantial modification. Applications for an opinion and, where applicable, for authorisation of substantial modifications are submitted, within fifteen days of the introduction of urgent safety measures,…