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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.

Forms

Responsible for you

Regierung von Oberfranken - Sachgebiet 53.2 - Pharmazie

Procedure details

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).

The statutory processing period is a maximum of three months. The period begins when all documents and information are complete.

Administrative court action
Status: 17.04.2025
Editorially responsible for prodecure description: Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention
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