Subsection 2: Special provisions for the importation of labile blood products for direct therapeutic use.

The authorisation to import labile blood products for direct therapeutic use is issued by the Agence nationale de sécurité du médicament et des produits de santé to the Armed Forces Blood Transfusion Centre and to blood transfusion establishments which store labile blood products for direct therapeutic use with a view to their distribution and issue in application of article L. 1221-10.

By way of derogation from the provisions of g of Article D. 1221-61, when labile blood products from several samples are imported with a view to a scheduled autologous transfusion and the planned date of the procedure so requires, the importer may provide only the results of the tests and analyses performed on the first sample. The import authorisation may be issued on the basis of the results of the…