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

Tissue in the sense of § 1a number 4 of the Transplantation Act or tissue preparations in the sense of § 20c paragraph 1 sentence 1 or sentence 2 of the German Medicines Act (AMG) may only be imported with a permit. The decision on the granting of permission is made by the competent authority of the Land in which the operating site of the importing tissue establishment is located, 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.

Preconditions
The requirements result from § 72 b AMG.
The notification is to be made informally to the competent government

Responsible for the content
Bayerisches Staatsministerium für Gesundheit und Pflege (Bavarian State Ministry of Health and Care)

Last update or date of publication
24.09.2020