1 Amendments of Jo LEINEN related to 2008/0238(COD)
Amendment 73 #
Proposal for a directive
Recital 13
Recital 13
(13) An organ donor is also very often a tissue donor. Quality and safety requirements for organs should complement and be linked with the existing Community system for tissues and cells laid down in Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells10. An unexpected adverse reaction in an organ donor or recipient should be traced by the competent authority or body and reported in the tissue vigilance system as provided for in that Directive. (This amendment should apply throughout the text)