Pharmaceutical production; application for a permit for the extraction of tissue and laboratory tests

The collection of tissue and laboratory tests are subject to authorization.

Formloser Antrag (ohne Unterschrift)

This form can be submitted electronically without signature (e.g. via a secure contact form or by e-mail) or in paper form to the responsible authority.

For contact details of the responsible authoritiy and local valid information select under "Select location" a location.

Anyone wishing to obtain tissue or carry out 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 are set out in Section 20 b AMG.

The application must be submitted informally to the responsible government.

A fee of between €500 and €20,000 is set on the basis of the administrative work and time involved and the importance of the matter for the applicant (according to the list of costs - tariff no. 7.IX.8/tariff item 1.1.2.1). This also includes expenses for necessary on-site inspections by our pharmaceutical officials (according to the list of costs - tariff no. 7.IX.8/tariff item 1.2).