The European Council adopted on 3rd March 2004 a proposal for a directive setting out harmonised safety and quality standards for dealing with human tissues and cells.
The Council adopted all the amendments proposed by the European Parliament in second reading.
The dossier was amended in second reading on the rules for voluntary donation, traceability and types of source material used for transplantation.
Standards of quality and safety of human tissues and cells
UPDATE: On February 2006 the European Commission published a background document containing questions and answers on human tissues and cells.
The Q&A clarify that the 2004 Directive, which established a general framework of principles and common rules for the safety and quality of these substances, must be fully implemented by April 2006.
The Commission will work with Member State authorities to ensure the new measures on donation, procurement and testing of tissues and cells can be put in place smoothly. At the same time, the Commission published a new Directive 2006/17/EC on technical requirements for the donation, procurement and testing of human tissues and cells.
