French Public Health Code
In forceI.-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 :
1° Evidence of any kind in support of the application ;
2° The operating procedures for the depot, including in particular the list and qualifications of staff, a plan of the premises and a list of the equipment used;
3° The arrangements for securing the depot and labile blood products;
4° The arrangements for issuing or transferring labile blood products;
5° The agreement provided for in article R. 1221-20-2 between the health establishment or health cooperation group and the referring blood establishment.
The Director General of the Regional Health Agency decides on the application after obtaining the opinion of the Etablissement Français du Sang or, where applicable, the Armed Forces Blood Transfusion Centre, when the latter is the applicant's referring blood establishment, and that of the Regional Haemovigilance and Transfusion Safety Coordinator. In the absence of a response from the latter within two months, their opinion is deemed to have been given.
The Director General of the Regional Health Agency will notify the director of the health establishment or the group administrator of his decision within four months of the date of receipt of the application accompanied by a complete file. If no response is received by the end of this period, the authorisation is deemed to have been refused.
The authorisation is issued for a period of five years. It specifies the category to which the authorised blood depot belongs. A copy of the authorisation decision is sent to the Etablissement Français du Sang or, where applicable, to the armed forces blood transfusion centre and to the regional haemovigilance and transfusion safety coordinator.
II - A new authorisation is required in the event of substantial modification to the elements of the initial authorisation.
The application for a new authorisation must be accompanied by the updated agreement provided for in article R. 1221-20. It is submitted, investigated and the subject of a decision issued and notified under the conditions set out in I.
Authorisation for substantial modification is granted for a period of five years. The decision shall specify the category to which the authorised blood depot belongs.
The following constitutes a substantial modification
1° A change in the category of depot ;
2° A change of premises ;
3° A change of site of the blood establishment responsible for supplying the blood establishment.
III - The application for renewal of the authorisation to manage a blood establishment is submitted, examined and is the subject of a decision issued and notified under the conditions set out in I. This application is accompanied by the updated agreement provided for in article R. 1221-20-2.
The Director General of the Regional Health Agency will notify the director of the health establishment or the group administrator of his decision within four months of the date of receipt of the application for renewal.
If no response is received, the renewal authorisation is deemed to have been granted.
Renewal of the authorisation is granted for a period of five years. The decision specifies the category to which the authorised blood depot belongs.
