Pharmaceutical manufacturing; application for a permit for tissue collection and laboratory testing.
Tissue collection and laboratory testing are subject to licensing.
Anyone wishing to obtain tissue or perform laboratory tests in this context must apply for a permit in accordance with Section 20b of the German Medicines Act (AMG).
The notification can be sent informally by e-mail to the responsible government:
- Government of Upper Franconia - responsible for the administrative districts of Upper Palatinate, Upper Franconia, Middle Franconia and Lower Franconia.
- Government of Upper Bavaria - responsible for the administrative districts of Upper Bavaria, Lower Bavaria and Swabia.
The requirements result from § 20 b AMG.
The application must be submitted informally to the relevant government.
The statutory processing period is three months at the longest. The period begins to run when all documents and information are complete.
Please select a location in "Localization" so that the address of the responsible authority can be filled in.
Prefillable Form, Bavaria-wide:
Formloser Antrag (ohne Unterschrift)
This form requires no signature. You can sent it electronically (e.g. by secure email or De-Mail) or as hardcopy to the responsible authority.
A fee of between €500 and €20,000 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 184.108.40.206). 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