Chapter I: Collection, preparation and storage of blood, blood components and labile blood products

I.-The application for an initial authorisation to manage a blood establishment is sent by the director of the health establishment or by the administrator of the grouping to the regional health agency, by any means enabling receipt of the application to be dated with certainty. The order of the Minister for Health provided for in article R. 1221-20-1 defines the content of the application for authorisation, which includes in particular…

Non-substantial modifications must be declared to the regional health agency. A copy is sent to the Etablissement français du sang or, where applicable, to the Centre de transfusion sanguine des armées. Non-substantial modifications are modifications that are not listed in article R. 1221-20-3 and in particular: 1° The appointment of a new depot manager; 2° The change of equipment appearing on the list of health depot equipment determined by order…

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,…

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

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.

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…