Approvals
In Germany, the Paul-Ehrlich-Institut (PEI) grants permits or certificates for
- tissue preparations in accordance with §21a (1) AMG (Arzneimittelgesetz, Medicinal Act)
- non-routinely manufactured Advanced Therapy Medicinal Products (ATMP) according to 4b (3) AMG
- stem cell preparations according to § 21a (1) AMG.
Updated: 21.11.2019
