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European Union Tissues and Cells Directives

The European Union Tissues and Cells Directives (EUTCD) introduced common safety and quality standards for human tissues and cells across the European Union (EU).

The purpose of the directives was to facilitate a safer and easier exchange of tissues and cells (including human eggs and sperm) between member states and to improve safety standards for European citizens.

The EUTCD was adopted by the Council of Ministers on 2 March 2004 and published in the Official Journal of the European Union on 7 April 2004. Member States were obliged to comply with its provisions from 7 April 2006. 

 

The directives

The European Tissues and Cells Directive or the Parent Directive (Directive 2004/23/EC) concerns standards for donation, procurement and testing, processing, preservation, storage and distribution.

The First Technical Directive (Directive 2006/17/EC) covers donation, procurement and testing.

Annex two and three of the first technical directive were amended in November 2012. View amendments to Annex two and three.

The Second Technical Directive (Directive 2006/86/EC) covers standards for traceability, notification of serious adverse reactions and events, and requirements for coding processing, preservation, storage and distribution.

These Directives were absorbed into the Human Fertilisation and Embryology Act 1990 through additional regulations in 2007.

 

Page last updated: 16 April 2009

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The HFEA held a public consultation on the matter. Find out the results.

...more about Hybrids and Chimeras

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This ensures that every licensed clinic is adhering to safety and ethical rules set out by the UK government.

...more about our regulation process