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PR(08)43: Iceland fails to implement technical quality and safety requirements for the use of human tissues and cells

16.7.2008

The EFTA Surveillance Authority has decided to send two reasoned opinions to Iceland for failure to implement Directive 2006/17/EC and Directive 2006/86/EC both implementing Directive 2004/23/EC as regards certain technical quality and safety requirements for the use of human tissues and cells.

Iceland should have implemented Directive 2006/17/EC by 7 July 2007 and Directive 2006/86/EC by 1 September 2007.

The use of human tissues and cells for application in the human body offers great opportunities for both therapeutic purposes and the treatment of as yet incurable diseases. In order to safeguard public health and to prevent the transmission of diseases by human tissues and cells, the Directive establishes technical quality and safety requirements for each one of the steps in the human tissue and cell application process.

The purpose of the Authority’s reasoned opinion is to give Iceland a last chance to take corrective measures before the Authority decides whether to bring the matter before the EFTA Court. Iceland has been given three months to take the measures necessary to comply with the reasoned opinion.

 

For further information, please contact:

Mr Steven Verhulst
Officer, Internal Market Affairs Directorate
Tel: (+32)(0)2 286 18 58

16 July 2008




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