Article R1222-43 of the French Public Health Code
I. – 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…