Human Tissue Authority

The regulator for human tissue and organs

How was the EU Tissues and Cells Directive (EUTCD) brought into UK law?

From 7 April 2006, the European Commission required that Members States bring into force the laws, regulations and administrative provisions necessary to comply with the Parent Directive (Directive 2004/23/EC). In order to comply with the European Directive the HTA commenced licensing the storage of human tissues and cells for transplantation on 7 April 2006.

Alongside the commencement of licensing the HTA issued Directions (Directions 001/2006), summarising the requirements of the Parent Directive and the first technical Directive (Directive 2006/17/EC) to licensed establishments. All establishments were required to comply with Directions 001/2006 by April 2007.

The Parent Directive, the first technical Directive and the second technical Directive (Directive 2006/86/EC) were formally adopted into UK law on 5 July 2007 via a statutory instrument called 'The Human Tissue (Quality and Safety for Human application) Regulations 2007, in short 'the Regulations'.

The HTA issued a second set of Directions (Directions 002/2007), which set out the requirements of the Regulations and the second technical Directive of the EUTCD and supplement and amend the first set of Directions.

The HTA issued a further set of Directions (Directions 004/2007) which came into force on 7 October 2007. These Directions stipulate that imports of tissues and/ or cells from non-European Economic Area (EEA) states meet standards of quality, safety and traceability equivalent to those provided in the Regulations.

The HTA issued Directions 003/2010 which came into force on 12 November 2010. These Directions consolidate and clarify the standards required under the Human Tissue (Quality and Safety of Tissues and Cells for Human Application) Regulations 2007. These Directions revoke Directions 001/2006, 002/2007 and 004/2007.

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Quality and Safety Regulations FAQs