Subsection 2: Approvals

I. – An order of the Minister for Health and the Minister for Defence, issued on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, specifies the procedures for submitting applications for approval and for amending the approvals provided for in III and VI of article L. 1222-11, as well as the content of the file accompanying each application. II….

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…

Changes other than those subject to authorisation or declaration are described in the annual activity report provided for in article R. 1222-35.

The Director of the Agence nationale de sécurité du médicament et des produits de santé may ask the applicant for any additional information required to examine the application. The request for additional information sets the time limit within which the Etablissement Français du Sang or the Armed Forces Blood Transfusion Centre must respond. The three-month period provided for an application for approval or modification of approval is suspended until receipt…

The President of the Etablissement Français du Sang or the Director of the Armed Forces Blood Transfusion Centre is notified of the decision of the Director General of the Agence Nationale de Sécurité du Médicament et des Produits de Santé granting approval or authorising modification of the elements of approval by registered letter with acknowledgement of receipt. A copy of this decision is sent to the Minister for Health and,…