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PR(07)15: Iceland fails to implement rules on quality and safety standards for activities in relation to human tissues and cells


The EFTA Surveillance Authority has decided to send a reasoned opinion to Iceland for failure to implement Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

Iceland should have implemented the Directive by 7 April 2006.

The transplantation of human tissues and cells 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 infectious diseases by tissues and cells, the Directive aims to establish high standards of quality and safety for all activities involving tissues and cells.

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 two months to take the measures necessary to comply with the reasoned opinion.

For further information, please contact:

Mr Hallgrímur Ásgeirsson
Director, Internal Market Affairs Directorate
Tel. (+32)(0)2 286 18 60;

Ms Tuula Nieminen
Deputy Director, Internal Market Affairs Directorate
Tel: (+32)(0)2 286 18 67; or

Ms Mia S. Hodgson
Senior Officer, Internal Market Affairs Directorate
Tel: (+32)(0)2 286 18 70

24 April 2007

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