Tissue and Cells Directives

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The European Union Tissue and Cells Directives (EUTCD)

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).

Alongside the commencement of licensing the European Union members, 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 is the first technical Directive and the second technical Directive (Directive 2006/86/EC).

The European Union Tissue and Cells Directives set out to establish a harmonised approach to the regulation of tissues and cells across Europe. The Directives set a benchmark for the standards that must be met when carrying out any activity involving tissues and cells for human application (patient treatment). The Directives also require that systems are put in place to ensure that all tissues and cells used in human application are traceable from donor to recipient.

The EUTCD is made up of three Directives, the parent Directive (2004/23/EC) which provides the framework legislation and two technical directives (2006/17/EC and 2006/86/EC), which provide the detailed requirements of the EUTCD.

Two new EU Directives are being put in place for the coding and import of tissues and cells for human application. These Directives are due to come into force throughout the EU. When implemented, all establishments licensed in the human application sector will need to meet the requirements laid out in these Directives.

The Directives will affect particular groups of establishments, such as:

  • private tissue banks;
  • commercial importers and distributors;
  • registries and hematopoietic stem cell (HSC) transplant centres;
  • tissue banks; and
  • establishments procuring for advanced therapy medicinal product (ATMP) manufacture.

In the Uk, the draft Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2017 are due to come into force during Summer 2017 and will transpose the EU Directives on Coding and Import into UK law.

Further information

European Directive 2004/23/EC (Parent Directive)
European Directive 2006/17/EC (First technical directive)
European Directive 2006-86-EC (Second technical directive)
European Directive 2012/39/EU (Third technical directive)

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