A manufacturing authorization pursuant to Section 13 of the German Medicines Act (AMG) is required by anyone who
- Medicinal products as defined in Section 2 (1) or (2) No. 1 AMG,
- test sera,
- test antigens,
- active substances which are of human, animal or microbial origin or are produced by genetic engineering, as well as other substances of human origin intended for the production of medicinal products
is manufactured commercially or professionally for the purpose of supply to others.
Manufacturing is the extraction, production, preparation, processing, decanting, including filling, packaging, labeling and release of medicinal products.
The manufacturing authorization must be applied for informally before commencing the activity.
The governments of Upper Bavaria and Upper Franconia are responsible for the supervision of manufacturers of human and veterinary medicinal products, active substances and substances of human origin for the manufacture of medicinal products who require a permit in accordance with Section 13 AMG. Locally, the Government of Upper Bavaria is responsible for the administrative districts of Lower Bavaria, Upper Bavaria and Swabia and the Government of Upper Franconia for the administrative districts of Middle Franconia, Upper Franconia, Lower Franconia and Upper Palatinate.