Working principles | Legal foundations

The CTC operates in accordance with the following legal requirements:

  • Parts 1 and 2 of the European Guidelines on Good Manufacturing Practice (GMP) 
  • the law regulating the marketing of medicinal products (German Medicinal Products Act - AMG)
  • the law regulating the transfusion system (German Transfusion Act -TFG)
  • the law regulating the donation, removal and transplantation of organs and tissue (German Transplantations Act - TPG)
  • the ordinance governing the application of Good Manufacturing Practice for the manufacture of medicinal products and of active pharmaceutical ingredients as well as the application of Codes of Good Practices (Gute fachliche Praxis, GfP) for the manufacture of products of human origin (AMWHV)
  •  the ordinance regulating the requirements applicable to the quality and safety of the procurement of tissue and their transfer according to the German Transplantation Act (TPG-GewV)
  • the relevant guidelines developed by the Scientific Committee of the German Medical Association with the cooperation of the Paul-Ehrlich Institute (RiLiBÄK)
  • along other relevant provisions and regulations.