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PR(06)29: Liechtenstein fails to implement rules relating to technical requirements and standards for collecting and testing of blood and blood components


The EFTA Surveillance Authority today delivered reasoned opinions to Liechtenstein due to its failure to implement two Directives relating to:

  • Standards for collecting and testing of blood and blood components[1]; and
  • Technical requirements for blood and blood components[2].

Liechtenstein should have implemented the Directives by 1 July 2005 and 1 August 2005, respectively.

The objective of the two Directives is to establish technical requirements for the collection and testing of all human blood and blood components, whatever their intended purpose, in order to ensure that there is common level of safety and quality of blood components and a high level of human health protection.

The Directives provide for rules concerning, inter alia, the following issues:

  • Designation, authorization, accreditation or licensing of blood establishments;
  • Quality management for blood establishments;
  • Traceability of blood and blood components from donor to recipient and vice versa; and
  • Data protection and confidentiality issues.

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

[1] Directive 2002/98/EC 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.

[2] Directive 2004/33/EC implementing Directive 2002/98/EC as regards certain technical requirements for blood and blood components.

For further information, please contact:
Mr. Hallgrímur Ásgeirsson
Director, Internal Market Affairs Directorate
Tel. (+32)(0)2 286 18 60

29 June 2006

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