Medicinal products; application for a licence to manufacture medicinal products for human and veterinary use and active substances subject to authorisation
You require a manufacturing authorisation if you wish to manufacture medicinal products within the meaning of Section 2(1) or (2)(1) of the German Medicinal Products Act, test sera, test antigens or active substances of human or animal or microbial origin or produced by genetic engineering, as well as other substances of human origin intended for the manufacture of medicinal products, on a commercial or professional basis for the purpose of supplying them to others.
A manufacturing authorisation in accordance with Section 13 of the German Medicines Act (AMG) is required by anyone who
- Medicinal products within the meaning of Section 2(1) or (2)(1) of the 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
manufactured commercially or professionally for the purpose of supply to others.
Manufacture is the extraction, production, preparation, treatment, processing, decanting, including filling, packaging, labelling and release of medicinal products.
The manufacturing authorization must be applied for informally prior to commencement of 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 as well as substances of human origin for the manufacture of medicinal products who require a licence according to § 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 the Schedule of Costs - Tariff No. 7.IX.8/Tariff item 126.96.36.199). 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
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