Article R1211-39 of the French Public Health Code
Without prejudice to the obligation referred to in Article L. 1413-14: 1° Any healthcare professional practising in an establishment or structure with a local biovigilance correspondent who is aware of the occurrence of a serious incident or unexpected adverse reaction must report it without delay to this correspondent or, failing this, to his deputy. If the local correspondent and his/her alternate are unable to act, the healthcare professional must report…