Subsection 3: Local biovigilance system

The establishments and organisations mentioned in 3° of Article R. 1211-32 organise the implementation of the local biovigilance system, in particular by providing professionals with the tools they need to carry out their tasks of monitoring, reporting or declaring incidents and adverse reactions. The Agence de la biomédecine provides methodological tools for this purpose. The local biovigilance system sets out the procedures for informing the director of the establishment and…

I. – The establishments and organisations mentioned in 3° of Article R. 1211-32 appoint at least one local biovigilance correspondent and a deputy. As soon as they are appointed, the identity, status, experience and contact details of the local biovigilance correspondent and his/her alternate are communicated to the Agence de la biomédecine by the head of the structure in which the correspondent and his/her alternate perform their duties. The provisions…

I. – The local biovigilance correspondent is responsible for : 1° Ensuring that surveillance of incidents and adverse reactions is set up by healthcare professionals involved in the activities mentioned in 2° of I of article R. 1211-29; 2° Collecting, storing and making accessible the information communicated to it relating to incidents and adverse reactions; 3° Identifying and declaring serious incidents and unexpected adverse reactions to the Agence de la…

Each establishment or organisation mentioned in a or c of 3° of Article R. 1211-32, ensures that a procedure is put in place to prevent the use of the elements, products or derivatives mentioned in 1° of I of Article R. 1211-29 likely to present a quality or safety defect.

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…