French Business Law - French Legislation

Article R1221-20-5 of the French Public Health Code

November 5, 2023

I.-The refusal of authorisation to manage a blood establishment, its renewal or the substantial modification of one of its elements is notified to the director of the health establishment or to the administrator of the consortium by the director general of the regional health agency. A copy of this decision is sent to the regional haemovigilance and transfusion safety coordinator and to the Etablissement Français du Sang or, where applicable,…

Article D1221-20-6 of the French Public Health Code

November 5, 2023

Blood banks are subject to at least one inspection by the regional health agency during the period of validity of the authorisation.

Article D1221-20-7 of the French Public Health Code

November 5, 2023

For the application of this section, the Minister of Defence shall exercise the powers conferred on the competent regional health agency for army hospitals, whose technical opinion he may seek if necessary.

Article R1221-21 of the French Public Health Code

November 5, 2023

Blood establishments, health establishments and health cooperation groups authorised to store labile blood products intended for therapeutic use must have a procedure for withdrawing any unit of such products from the circuit. An order by the Minister for Health sets the conditions under which health establishments may store in their departments labile blood products issued, with a view to a transfusion procedure, by their referral blood establishment or by the…

Article R1221-22 of the French Public Health Code

November 5, 2023

The aim of transfusion safety is to identify hazards that have caused, are causing or are likely to cause incidents or adverse reactions that have threatened, are threatening or may threaten the health of donors or recipients, in order to eliminate or reduce the associated risks. Haemovigilance is a component of transfusion safety. It involves, for any donation of blood or blood components and for any labile blood product: 1°…

Article R1221-23 of the French Public Health Code

November 5, 2023

For the purposes of this section, the following definitions shall apply 1° Adverse reaction: a harmful reaction in donors associated or possibly associated with the collection of blood or in recipients associated or possibly associated with the administration of a labile blood product; 2° Serious adverse reaction: an adverse reaction resulting in death or life-threatening, disabling or incapacitating, or causing or prolonging hospitalisation or any other morbid condition; 3° Incident…

Article R1221-25 of the French Public Health Code

November 5, 2023

The Agence nationale de sécurité du médicament et des produits de santé is responsible for implementing haemovigilance and transfusion safety. It defines the guidelines, leads and coordinates the actions of the various parties involved and ensures compliance with the monitoring procedures organised by this section. Where necessary, it shall take appropriate measures to ensure transfusion safety or refer the matter to the competent authorities. In order to carry out this…

Article R1221-26 of the French Public Health Code

November 5, 2023

The Agence nationale de sécurité du médicament et des produits de santé provides the Etablissement français du sang and the centre de transfusion sanguine des armées with information relating to the safety and quality of labile blood products resulting from the performance of the vigilance tasks relating to health products mentioned in article R. 1413-61-4.

Article R1221-27 of the French Public Health Code

November 5, 2023

Each year, the Agence nationale de sécurité du médicament et des produits de santé draws up a summary report on haemovigilance and transfusion safety. This report is sent to the Minister for Health and to the European Commission by 30 June of the following year at the latest.

Article R1221-32 of the French Public Health Code

November 5, 2023

In each region, regional haemovigilance and transfusion safety coordinators carry out their vigilance duties under the conditions defined in article R. 1413-61-4.

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Article R1221-20-5 of the French Public Health Code

Article D1221-20-6 of the French Public Health Code

Article D1221-20-7 of the French Public Health Code

Article R1221-21 of the French Public Health Code

Article R1221-22 of the French Public Health Code

Article R1221-23 of the French Public Health Code

Article R1221-25 of the French Public Health Code

Article R1221-26 of the French Public Health Code

Article R1221-27 of the French Public Health Code

Article R1221-32 of the French Public Health Code

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