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.
Please select a location in "Localization" so that the address of the responsible authority can be filled in.
Prefillable Form, Bavaria-wide:
Formloser Antrag (mit Unterschrift)
This form has to be signed and sent to the responsible authority. You can sign the form manually and send it by email/fax or sign the form electronically with your qualified electronic signature an send it by (secure) email. If the responsible authority has set up a De-Mail account, you can also send the form by De-Mail using an sender-confirmed message.
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 188.8.131.52). 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, Pflege und Prävention
- Online transactions, Bavaria-wide
- Online transactions, locally limited
- Form, Bavaria-wide
- Form, locally limited
- Prefillable Form, Bavaria-wide
- Legal bases, Bavaria-wide
- Legal bases, locally limited
- Fees, Bavaria-wide
- Fees, locally limited