French Business Law - French Legislation

Article R1221-45 of the French Public Health Code

November 5, 2023

I.- The mission of the institutional medical committees in public health establishments and the institutional medical conferences in private health establishments is, in particular, to contribute through their studies and proposals to improving the safety of patients transfused in the health establishments in which they are set up. These bodies ensure the implementation of the haemovigilance and transfusion safety rules and procedures provided for in this section and in particular…

Article R1221-46 of the French Public Health Code

November 5, 2023

When the agenda concerns transfusion safety and haemovigilance, the following are present as of right at meetings of the institutional medical committee in public health establishments or the institutional medical conference in private health establishments: 1° The regional haemovigilance and transfusion safety coordinator ; 2° The haemovigilance and transfusion safety correspondent of the referring blood establishment; 3° The haemovigilance and transfusion safety correspondent for the health establishment; 4° The head…

Article R1221-47 of the French Public Health Code

November 5, 2023

The regional haemovigilance and transfusion safety coordinator receives the minutes, reports and other documents relating to transfusion safety and haemovigilance drawn up by the hospital medical committee or hospital medical conference. It informs the Agence Nationale de Sécurité du Médicament et des Produits de Santé, the Director General of the Regional Health Agency and the Central Director of the Armed Forces Health Service, as necessary.

Article R1221-48 of the French Public Health Code

November 5, 2023

I. – The health care organisation’s medical committee or medical conference may refer any matter relating to the implementation of haemovigilance rules in the health care organisation to the regional haemovigilance and transfusion safety coordinator and the Agence nationale de sécurité du médicament et des produits de santé. II. – In public health establishments and health cooperation groups set up as public health establishments, the director, when approached by the…

Article R1221-49 of the French Public Health Code

November 5, 2023

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…

Article R1221-49-1 of the French Public Health Code

November 5, 2023

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…

Article R1221-49-2 of the French Public Health Code

November 5, 2023

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…

Article R1221-49-3 of the French Public Health Code

November 5, 2023

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.

Article R1221-49-4 of the French Public Health Code

November 5, 2023

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….

Article R1221-50 of the French Public Health Code

November 5, 2023

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.

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Regulatory part

Article R1221-45 of the French Public Health Code

Article R1221-46 of the French Public Health Code

Article R1221-47 of the French Public Health Code

Article R1221-48 of the French Public Health Code

Article R1221-49 of the French Public Health Code

Article R1221-49-1 of the French Public Health Code

Article R1221-49-2 of the French Public Health Code

Article R1221-49-3 of the French Public Health Code

Article R1221-49-4 of the French Public Health Code

Article R1221-50 of the French Public Health Code

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