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Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC article annex_III CELEX: 02002L0098-20090807 LABELLING REQUIREMENTS
The label on the component must contain the following information:
— the official name of the component
— the volume or weight or number of cells in the component (as appropriate)
— the unique numeric or alphanumeric donation identification
— the name of producing blood establishment
— the ABO Group (not required for plasma intended only for fractionation)
— the Rh D Group, either Rh D positive or Rh D negative (not required for plasma intended only for fractionation)
— the date or time of expiry (as appropriate)
— the temperature of storage
— the name, composition and volume of anticoagulant and/or additive solution (if any). |