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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 any serious incident or unexpected adverse reaction to the Agence de la biomédecine without delay;

2° Any healthcare professional practising in an establishment or structure that does not have a local correspondent who is aware of the occurrence of a serious incident or unexpected adverse reaction must report it to the Agence de la biomédecine without delay;

3° Any other healthcare professional who is aware of an adverse reaction which, on the basis of the information in their possession, appears to be related to the elements, products or derivatives mentioned in 1° of I of Article R. 1211-29 or to the activities mentioned in 2° of this same I reports it without delay to the local correspondent of the structure which was involved in the activities in question or which treated the person concerned by the adverse reaction.

Original in French 🇫🇷
Article R1211-39
Sans préjudice de l’obligation mentionnée à l’article L. 1413-14 :


1° Tout professionnel de santé exerçant dans un établissement ou une structure disposant d’un correspondant local de biovigilance et qui a connaissance de la survenue d’un incident grave ou effet indésirable inattendu le signale sans délai à ce correspondant ou, à défaut, à son suppléant. En cas d’empêchement du correspondant local et de son suppléant, le professionnel de santé déclare sans délai à l’Agence de la biomédecine tout incident grave ou effet indésirable inattendu ;


2° Tout professionnel de santé exerçant dans un établissement ou une structure ne disposant pas d’un correspondant local qui a connaissance de la survenue d’un incident grave ou d’un effet indésirable inattendu le déclare sans délai à l’Agence de la biomédecine ;


3° Tout autre professionnel de santé ayant connaissance d’un effet indésirable qui, au vu des informations en sa possession, lui semble lié aux éléments, produits ou dérivés mentionnés au 1° du I de l’article R. 1211-29 ou aux activités mentionnées au 2° de ce même I le signale sans délai au correspondant local de la structure qui est intervenue dans le cadre des activités en cause ou qui a pris en charge la personne concernée par l’effet indésirable.

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