Transport of Biological Samples to Germany: Customs Requirements, Legal Regulations, and Practical Advice for Visitors and Patients

With the expansion of medical tourism and international cooperation, transporting biological samples from one country to another has become common – whether for specialized tests, stem cell storage, or genetic analysis in German laboratories. However, such transport is subject to strict customs and health regulations.

Which biological samples are included?

• Blood samples

• Tissue samples

• Bodily fluids (e.g., urine, saliva, amniotic fluid)

• Genetic material (DNA, RNA)

• Stem cells

• Prepared histological slides

• Laboratory samples under refrigeration

Key legal frameworks:

1. EU Regulation 2019/1020: Governs medical and biological products in the EU market and requires a legal representative.

2. German Customs Law: Classifies biological samples as “special goods” and requires precise declaration at entry.

3. German Infection Protection Act (IfSG § 72 ff.): Regulates handling of potentially infectious material and mandates safe transport methods.

Basic requirements for transport:

• Export documents: Doctor’s letter + medical report explaining purpose

• Customs declaration: Detailed description of content, type, and purpose

• Safe medical transport: Use of internationally approved packaging (UN3373)

• Proper cooling chain: With guarantee seal if needed

• Approval from German laboratory: Sometimes required

• Additional permit: For stem cells or tissues from Paul-Ehrlich-Institut

Do samples need medical authorization? Yes, if considered potentially infectious. Requirements include:

• Certificate from national health authority

• Sealed containers labeled “Biological Material – non-infectious” or “Category B”

• Prior approval from German customs in special cases

Transport methods:

1. International medical shipping services: e.g., DHL Medical Express, World Courier

2. Human courier: Hand-carried in medical cooler with full documentation

Reasons for rejection or confiscation:

• Unclear medical purpose

• Non-compliant packaging

• Suspicion of infectious material without permit

• Undeclared transport in luggage

• Data mismatch with doctor’s letter

Practical tips:

• Ensure German laboratory is licensed to handle foreign samples

• Request UN classification label for packaging

• Always notify German customs in advance to avoid violations

Conclusion: Transporting biological samples to Germany is possible and legal but requires careful preparation and strict compliance with EU and German regulations. Transparent documentation, safe packaging, and a clear medical purpose are key.