title: [Report on notifications according to Section 8d of the German Transplantation Act (TPG) for the year 2008].
abstract: 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.
authors.affiliation: Fachgebiet 6/4 Avitale Gewebezubereitungen, Xenogene Zelltherapeutika, Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Langen, Deutschland. Dagmar.Schilling-Leiss@pei.de
authors.forename: D
authors.initials: D
authors.lastname: Schilling-Leiss
authors.forename: F
authors.initials: F
authors.lastname: Bracone
authors.forename: M
authors.initials: M
authors.lastname: Selbert
authors.forename: L
authors.initials: L
authors.lastname: Reinmann
authors.forename: R R
authors.initials: RR
authors.lastname: Tönjes
mesh_terms: D005062:European Union / Q000706:statistics & numerical data; D005260:Female; D019983:Guideline Adherence / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D009313:National Health Programs / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data; D061214:Patient Safety / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence*; D027724:Reproductive Techniques, Assisted / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D014015:Tissue Banks / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D014019:Tissue Donors / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D016378:Tissue Transplantation / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data; D020858:Tissue and Organ Harvesting / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data