Cell Culture Service
Since the enactment of the Act, the removal of tissue biopsies for the production of cell transplants require authorization AMG § 20b (1) or (2). This means that either the medical institution must apply yourself permission for their competent national authority (§20b (1) or that it takes a GMP agreement with the DIZG and thus the DIZG requests permission from the competent state authority.
The DIZG has the manufacturing authorization according to § 13 AMG for the production of autologous cell transplants of skin cells. The DIZG, the clinic the required QMS documentation available and takes care of the requirements of the authority.