Arzneimittelrecht; Einfuhrerlaubnis und Zertifikate für Gewebe und bestimmte Gewebezubereitungen

The import of tissue / tissue preparations from a third country is subject to authorization.

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

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).

The notification must be made informally to the responsible government.