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Legal Framework

The following list provides access to all documents by clicking on the resolution, recommendation and guidance's name.

 

Council of Europe legal framework

Within the framework principle of sharing knowledge through international co-operation, the Council of Europe and the CD-P-TO and its predecessors have established widely-recognised recommendations and resolutions in the field of transplantation covering ethical, social, scientific and training aspects of organ, tissue and cell donation and transplantation.
Whereas Agreements and Conventions are binding on the states that ratify them, resolutions and recommendations are policy statements proposing a common course of action to governments that they can follow.

 

Agreements and Conventions

 

Recommendations

 

Resolutions

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European Union regulatory framework 

Organs

  • Directive 2012/25/EU on laying down information procedures for the exchange, between Member States, of human organs intended for transplantation
  • Directive 2010/53/EU on standards of quality and safety of human organs intended for transplantation

 

Tissues and cells

  • Directive 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells
  • Directive 2015/566 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells
  • Directive 2012/39/EU amending Directive 2006/17/EU as regards certain technical requirements for the testing of human tissues and cells
  • Directive 2006/86/EC on  traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells
  • Directive 2006/17/EC on technical requirements for the donation, procurement and testing of human tissues and cells
  • 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

 

Other relevant legislation

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WHO guidance documents 

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Additional guidance

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