An update on the European coding system for Human Application establishments
HTA Directions 002/2007 lays out in paragraphs 82 and 83 that Human Application establishments undertaking procurement, testing, processing, storage, distribution and/or import/export of tissues and/or cells for human application shall ensure that a single European identifying code is allocated to all donated material at the establishment to ensure:-
Issued 29 July 2009
- Proper identification of the donor;
- Traceability of all donated material; and
- Provision of information on the main characteristics and properties of tissues and/or cells.
The establishment will ensure that the code will incorporate, as a minimum the following information:-
Donation identification:
- Unique ID number; and
- Identification of the establishment; and
Product identification:
- Product Code (basic nomenclature);
- Split number (if applicable); and
- Expiry date.
A European Commission project commenced in 2006 and the final report was presented to the Competent Authorities meeting in 2008. The European Standardisation Committee developed a proposal that there should be a high level code which includes the country identification and tissue establishment number so that material could be traced from country to country. However the EC has not decided what sort of system there should be for allocating codes, who should run it and what role competent authorities would have (if any) in allocating codes to tissue establishments for each tissue that is procured and stored.
- There are financial implications for licensed establishments and competent authorities in implementing this European coding system, depending on the system the EC chooses to implement.
- The EC have advised that the project has been delayed because DG Sanco has been instructed to carry out a comprehensive Regulatory Impact Assessment of the coding system. There will be a full public consultation on the Regulatory Impact Assessment and then the outcome will be published during 2010.
The HTA will issue further guidance and/or Directions when the detailed requirements of the European Coding System required by the parent directive are clarified by the European Commission.