French Public Health Code
In forceI. - Prior written authorisation from the Director General of the Agence nationale de sécurité du médicament et des produits de santé is required for any change to the approval relating to :
1° A new transfusion activity ;
2° The premises in which these activities are carried out and the technical equipment subject to qualification in accordance with the good practices referred to in Article L. 1222-12 , where these changes to premises or equipment result in a change in the circulation of persons and products;
3° The creation of new premises in which activities are carried out;
4° A change in the geographical area in which a transfusion activity is carried out.
The Director General's decision is taken within three 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 modification authorisation is deemed to have been refused.
II. - Any change relating to :
1° The name or address of the registered office of the blood establishment or the Etablissement français du sang ;
2° The appointment of the director of the blood establishment;
3° the appointment of new persons responsible for the activities mentioned in articles R. 1222-35 to R. 1222-39 carried out in a blood establishment or at the Etablissement français du sang;
4° The withdrawal of a blood transfusion activity or the closure of a site where this activity is carried out in accordance with the regional blood transfusion organisation plans;
5° The preparation of labile blood products using new technology;
6° The distribution or issue of labile blood products by the blood establishment to a new blood depot;
7° The implementation of new medico-technical software used for authorised activities;
8° Any change in the arrangements put in place to ensure the continuity of the public transfusion service.
The first paragraph and 1° to 7° apply to the Armed Forces Blood Transfusion Centre.
The declaration is made no later than one month following the implementation of the aforementioned changes. It shall be sent by the President of the Etablissement Français du Sang or by the Director of the Armed Forces Blood Transfusion Centre to the Director General of the Agence Nationale de Sécurité du Médicament et des Produits de Santé by any means capable of confirming receipt of the declaration. It must be accompanied by a letter explaining the purpose and impact of the change on approved activities. The Director General of the Agency may ask the applicant for any additional information required in connection with this declaration.
