Permissions | Permits | Accreditations
The CTC has the following permits from the State Trade Supervisory Office (sGAA) Hanover, which is responsible for drug monitoring in Lower Saxony, permits from the Federal Institute for Vaccines and Biomedical Medicines, Paul Ehrlich Institute (PEI), and accreditations:
- Manufacturing permit §13 AMG for biological drugs
- GMP certificate for standard production
- GMP certificate for investigational drugs
- Permission for the extraction of tissue, treatment or processing
- Import permit for medicinal products
Approvals according to §21a AMG:
The Jacie accreditation in August 2014 was the successful conclusion of the joint two-year preparation of the Clinics for Hematology, Hemostaseology, Oncology and Stem Cell Transplantation as well as for Pediatric Hematology and Oncology, the Institute for Transfusion Medicine and the CTC.
The Joint Accreditation Committee ISCT EBMT (JACIE) is the joint accreditation body of the International Society for Cellular Therapy (ISCT: International Society for Cellular Therapy) and the European Society for Blood and Bone Marrow Transplantation (EBMT: European Society for Blood and Marrow Transplantation).
JACIE is committed to improving patient care worldwide through the dissemination of a unified quality management system based on the current state of medical and pharmaceutical science and technology for the transplantation of blood and bone marrow-derived stem cells of the hematopoietic system.
In addition to the program partners accredited with us, we would like to thank the clinics and central facilities of the MHH, the national and international registers and, above all, the donors, because diagnostics, accompanying therapy, pharmaceutical quality control, donor recruitment and procurement as well as altruistic blood and bone marrow donations make blood stem cell transplantation only possible at the MHH. The continuity of efforts is ensured by joint re-accreditation every two years.