Retention periods for records relating to the collection of blood and blood components, the manufacture of blood products and its use

Retention Periods for Documentation Relating to the Collection of Blood and Blood Components, the Manufacture of Blood Products and Their Application The collection of blood and blood components, the manufacture of blood products and the application of blood products has to comply with numerous obligations relating to the documentation and the retention period which are based in the law and recommendations. Addressees of these obligations are inter alia the physician, the blood establishment, the manufacturer, the holder of a marketing authorisation (pharmaceutical entrepreneur) or the sponsor. Practical experience has revealed that it is not easy for the concerned addressees to determine and fulfil the obligations to archive and to preserve the retention period in a reliable manner and to the necessary extent. In the following a practical approach is made to compile the essential retention periods relating to documentations in the field of blood. The essential legal basis concerning the retention period of documentations in the field of blood are cited.