Subsection 8: Obligation to report and declare.

I. – Any healthcare professional who observes or has knowledge of a serious incident shall report it without delay to the haemovigilance and transfusion safety correspondent of the establishment where the incident took place or to that of the establishment in which the incident was discovered. If he is unable to identify the incident, he will report it to any haemovigilance and transfusion safety correspondent in a blood establishment or…

I.-Any healthcare professional who observes or is aware of a serious adverse reaction occurring in a blood donor shall report it without delay to the haemovigilance and transfusion safety correspondent of the blood establishment where the product was collected. If he is unable to identify the donor, he will report it to any haemovigilance and transfusion safety correspondent in a blood establishment or health establishment, who will forward this information…

I. – Any healthcare professional who observes or is aware of an adverse reaction occurring in a recipient of labile blood products shall report it without delay to the haemovigilance and transfusion safety correspondent of the healthcare establishment in which the product was administered. If he is unable to identify it, he will report it to any haemovigilance and transfusion safety correspondent in a blood establishment, who will forward this…

If adverse reactions observed in a blood donor or in a recipient are likely to be due to a product mentioned in II of article L. 5311-1 falling within the scope of another vigilance, a copy of the adverse reaction report form for this donor or recipient is sent by the haemovigilance and transfusion safety correspondent to the correspondent for the vigilance concerned.

I. – Any healthcare professional who observes or is aware of post-donation information shall report it without delay to the haemovigilance and transfusion safety correspondent of the blood establishment where the blood donation was made. If he is unable to identify it, he will report it to any haemovigilance and transfusion safety correspondent in a blood establishment, who will forward this information to the relevant haemovigilance and transfusion safety correspondent….

The Agence nationale de sécurité du médicament et des produits de santé and the regional haemovigilance and transfusion safety coordinator simultaneously receive serious incident report forms, adverse reaction report forms for donors and recipients and post-donation information report forms. The Etablissement Français du Sang and the Armed Forces Blood Transfusion Centre each receive their own declaration forms.

Decisions by the Director General of the Agence nationale de sécurité des médicaments et des produits de santé, following consultation with the Etablissement français du sang and the Armed Forces Blood Transfusion Centre, set the form and content of serious incident report forms, adverse reaction report forms for donors and recipients and post-donation information report forms, as well as the procedures for their transmission. This decision may define the cases…

The provisions of this section shall apply to biomedical research on labile blood products, without prejudice to the provisions of Title II of Book I of Part One of this Code.