Schilling-Leiss D, Bracone F, Selbert M, Reinmann L, Tönjes R R
Fachgebiet 6/4 Avitale Gewebezubereitungen, Xenogene Zelltherapeutika, Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Langen, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011 Sep;54(9):1116-25. doi: 10.1007/s00103-011-1344-8.
In Germany, the tissue law came into effect on 1 August 2007. The law implemented the requirements of EC directives on quality and safety of human tissues and cells in the German Transplantation Act ("Transplantationsgesetz," TPG) and in the German Medicinal Products Act. Accordingly, tissue establishments are obligated to keep a record of their activities and to submit an annual report to the Paul-Ehrlich-Institut (PEI). The report shall include the types and quantities of tissues procured, conditioned, processed, stored, and distributed, or otherwise disposed of, imported and exported. For this purpose, the PEI published TPG-based notification forms in the Bundesanzeiger and in the Internet. The data provided by tissue establishments have been anonymized and compiled in a general report. The analysis revealed inconclusive data, which can be due to a number of different causes. To achieve better consistency of data provided in the future, the explanations for completing the notification forms will be amended. Thus far, compiled data are not appropriate to draw conclusions on the availability of tissues and tissue preparations in Germany, but the data can serve as reference points.
