S.L. 483.2 Art. 6Labelling and traceability of blood and blood components.

(1) A blood establishment shall ensure that the label on each unit of blood or blood component supplied by it, or imported by it from outside the European Community, shall contain all the information referred to under Schedule III.

(2) A blood establishment shall, for a period of not less than thirty years, keep such records of the information referred to in sub-regulation (1) and such additional records as are necessary -

(a) for the identification of each single blood donation and each single blood unit and its components, including blood and blood components which are imported into the European Community; and

(b) to ensure full traceability to the point of delivery to a hospital.