Book II: Donation and use of human body parts and products

When the import concerns plasma pastes or labile blood products intended for the preparation of health products, the authorisation referred to in Article D. 1221-58 is issued to the following organisations or establishments: 1° The Etablissement français du sang ; 2° The Armed Forces Blood Transfusion Centre; 3° Pharmaceutical establishments authorised in accordance with the provisions of article L. 5124-3 and manufacturing medicinal products; 4° Manufacturers of other health products…

When applying for an import authorisation, the importer must certify, notwithstanding the provisions of g of Article D. 1221-61, that the samples of blood or its components, from which the product for which the import authorisation is requested was prepared, comply with the requirements of Section 2 of this chapter. Where this is not the case, and provided that it is justified, the importer must provide an undertaking stating that…

The authorisation referred to in Article D. 1221-58 may be issued to the Etablissement Français du Sang for the importation of blood or its components intended for the preparation of labile blood products within the framework of an international agreement providing for cross-border cooperation. By way of derogation from the provisions of article D. 1221-60 and article D. 1221-61, these imports may be authorised if the blood samples or its…

Notwithstanding the provisions of the first paragraph of Article D. 1221-58, the import authorisation may be issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé on the basis of a forward programme submitted by the importer. At the end of the authorisation period, the importer draws up a report on the operations carried out and the quantity imported during the period.

By way of derogation from the provisions of the first paragraph of article D. 1221-58, when the Armed Forces Blood Transfusion Centre imports labile blood products with a view to processing them for foreign armed forces, the import authorisation is issued by the Agence nationale de sécurité du médicament et des produits de santé on the basis of a three-year programme and within the limit of a specified maximum overall…