Manufacture of medicinal products; application for authorization for the treatment, processing, preservation, testing, storage or placing on the market of tissues or tissue preparations

The treatment or processing, preservation, testing, storage or placing on the market of tissues or tissue preparations is subject to authorization.

Formloser Antrag (mit Unterschrift)
Dieser Assistent unterstützt Sie bei der Erstellung eines formlosen Schreibens, wenn die zuständige Stelle kein Antragsformular zur Verfügung stellt.

This form can be submitted electronically (e.g. via a secure contact form using your user account with login via the electronic ID function or the ELSTER certificate) or handwritten and signed 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 treat, process, preserve, test, store or place tissue or tissue preparations on the market must apply for a license in accordance with Section 20c 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 c AMG.

The notification must be made informally to the responsible government.

A fee of between €500 and €20,000 is set on the basis of the factual and time-consuming administrative work involved and the importance of the matter for the applicant (according to the list of costs - tariff no. 7.IX.8/tariff item 1.1.3.1). 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).