An import permit in accordance with Section 72 of the German Medicines Act (AMG) is required by anyone who
- Medicinal products within the meaning of Section 2 (1) or (2) No. 1 AMG,
- active substances which are of human, animal or microbial origin or which are produced by genetic engineering, or
- other substances of human origin intended for the manufacture of medicinal products
from countries which are not Member States of the European Union or other Contracting States to the Agreement on the European Economic Area into the area of application of this Act on a commercial or professional basis. The same shall apply to persons and institutions wishing to import medicinal products of human origin for direct human use on a professional or commercial basis.
The import permit must be applied for informally before commencing the activity. The governments of Upper Bavaria and Upper Franconia are responsible for issuing the import permit. The Government of Upper Bavaria is locally responsible for the administrative districts of Lower Bavaria, Upper Bavaria and Swabia and the Government of Upper Franconia for the administrative districts of Middle Franconia, Upper Franconia, Lower Franconia and Upper Palatinate.
For the import of medicinal products in the sense of § 2 Para. 1 and Para. 2 No. 1, 1a, 2, and 4 AMG as well as certain active substances subject to authorisation, a certificate according to § 72 a Para. 1 Sentence 1 No. 1 AMG or a certificate according to § 72 a Para. 1 Sentence 1 No. 2 AMG is also required.
A certificate according to Section 72 a (1) sentence 1 no. 1 AMG is sufficient
- if the competent authority of the country of manufacture has confirmed in this certificate that the medicinal products or active substances are manufactured in accordance with recognized rules for the manufacture and assurance of their quality (in particular those of the European Communities, the World Health Organization or the Pharmaceutical Inspection Convention), and
- such certificates are mutually recognized (i.e. between the Federal Republic and the respective manufacturing country).
If certificates are not mutually recognized, a certificate according to § 72 a para. 1 sentence 1 no. 2 AMG is required.
Such a certificate can only be issued if the competent authority or a competent authority of a Member State of the European Union or of another State party to the Agreement on the European Economic Area has regularly inspected the country of manufacture to ensure that the above-mentioned basic rules are observed in the manufacture of the medicinal products or active substances. The costs of such an inspection of the manufacturing site for medicinal products or active substances located abroad shall be borne by the applicant.
The Governments of Upper Bavaria and Upper Franconia are responsible for issuing the certificate according to Section 72 a (1) sentence 1 no. 2 AMG. The Government of Upper Bavaria is locally responsible for the administrative districts of Lower Bavaria, Upper Bavaria and Swabia and the Government of Upper Franconia for the administrative districts of Middle Franconia, Upper Franconia, Lower Franconia and Upper Palatinate.
Attention. The following applies to private individuals:
Medicinal products that are not authorised or registered in Germany are subject to a ban on movement in accordance with § 73 AMG. This means that these medicines may not be brought into Germany by private individuals. It is irrelevant here whether there is a corresponding or even identically named drug available for purchase in Germany.