Medicinal products; application for a permit to manufacture medicinal products for human use and active substances requiring a permit
You need a manufacturing authorization if you want to manufacture medicinal products within the meaning of Section 2 (1) or (2) of the German Medicines Act, test sera, test antigens or other specific active substances for the purpose of supplying them to others.
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.
Please select a location in "Localization" so that the address of the responsible authority can be filled in.
A fee of between €500 and €50,000 is set on the basis of the administrative effort and time involved and the importance of the matter for the applicant (according to Schedule of Costs - Tariff No. 7.IX.8/Tariff item 18.104.22.168). This also includes expenses for necessary site inspections by our pharmaceutical officials (according to the schedule of costs - tariff no. 7.IX.8/tariff item 1.2).
Links to more information
Responsible for editing: Bayerisches Staatsministerium für Gesundheit und Pflege
- Online transactions, Bavaria-wide
- Online transactions, locally limited
- Prefillable Form, Bavaria-wide
- Legal bases, Bavaria-wide
- Legal bases, locally limited
- Fees, Bavaria-wide
- Fees, locally limited