Section 13: Pharmacovigilance

When a person authorised to prescribe, dispense or administer medicinal products becomes aware of an adverse reaction which may be due to a blood-derived medicinal product, he/she shall report it immediately, even if he/she has not personally prescribed, dispensed or administered the medicinal product in question. The report must be sent : 1° When the medicinal product has been dispensed in a health establishment or a health cooperation grouping, to…

The correspondent mentioned in article R. 5121-181 who receives the report provided for in article R. 5121-196 immediately forwards it to the regional pharmacovigilance centre. If he is otherwise aware of an adverse reaction likely to be due to a blood-derived medicinal product, he shall report it immediately to the regional centre. When adverse reactions are likely to be due to the administration of blood-derived medicinal products to a patient…

The regional pharmacovigilance centres inform the Agence nationale de sécurité du médicament et des produits de santé on the same day of the reports of adverse reactions likely to be due to a blood-derived medicinal product that they have received.

Organisations or companies exploiting blood-derived medicinal products which have knowledge of adverse reactions likely to be due to these medicinal products inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé under the conditions set out in articles R. 5121-171 to R. 5121-173.

Blood establishments and organisations or companies manufacturing or exploiting blood-derived medicinal products which are aware of information likely to cast doubt on the quality of blood or plasma intended for fractionation inform each other. Blood transfusion establishments shall inform the President of the Etablissement Français du Sang. Organisations or companies manufacturing or exploiting medicinal products inform the Agence nationale de sécurité du médicament et des produits de santé. The Agence…

For the purposes of this sub-section, army hospitals and the army blood transfusion centre are regarded as public health establishments and blood transfusion establishments respectively.