List of Permits for Importing Blood and Blood Products for Rare Treatments

 

Import Permit for Blood and Blood Components in Germany for Rare Disease Therapy

In Germany, importing human blood and its derivatives for medical purposes is strictly regulated, especially for rare therapies requiring special foreign supplies – such as plasma from rare matching donors or specific blood cells for genetic or immune disorders. Oversight is provided by the Paul-Ehrlich-Institut (PEI) and Federal Customs Authority.

Basic Requirements

1. Applicant: Only licensed institutions (university hospitals, specialized centers, accredited blood banks, biomedical companies). Individuals cannot import directly.

2. Permitted Materials: Whole blood (rare cases), plasma (fresh/frozen), serum, leukocytes/erythrocytes, processed derivatives (IVIG, rare clotting factors).

3. Documents: Official request, medical justification with diagnosis, proof of non-availability in Germany, Certificate of Origin, safety certificate, patient’s written consent.

4. Transport/Storage: Specialized carriers with cold chain, compliance with GDP and EU blood safety guidelines.

Authorities Involved

• Paul-Ehrlich-Institut (PEI): Issues medical-biological permits.

• Customs Office: Verifies import authorization at borders.

• Local Health Office: Supervises clinical use and storage.

Processing Time

7–21 days; urgent request possible for emergencies.

Consequences Without Permit

Immediate confiscation, fines up to €25,000, possible criminal charges under AMG.

Authorized Uses

• Treatment of rare clotting disorders (e.g., FVIII inhibitor).

• Immune diseases requiring highly compatible plasma.

• Cell transplantation for Fanconi anemia.

• Antibody deficiency after bone marrow transplant.