Pharmaceutical legislation; import permits and certificates for tissues and certain tissue preparations

The import of tissue / tissue preparations from a third country 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.

Sie können die Behörde auf sichere Weise kontaktieren

Secure contact form

Street address

Maximilianstraße 39
80538 München

Hinweis: Wir empfehlen eine vorherige Terminvereinbarung bei persönlichen Vorsprachen

Postal address

80534 München

Mehr zur Behörde

Tissues within the meaning of Section 1a number 4 of the Transplantation Act or tissue preparations within the meaning of Section 20c paragraph 1 sentence 1 or sentence 2 of the German Medicinal Products Act (AMG) may only be imported with a permit. The competent authority of the federal state in which the establishment of the importing tissue establishment is located shall decide on the granting of the permit in consultation with the competent higher federal authority (Paul Ehrlich Institute).

The permit can be applied for informally by e-mail to the competent 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 § 72 b AMG.

The notification must be made informally to the responsible government.

A fee of between €200 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 6.4 and 6.5). 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 6.9).