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Germany – Peptide Import & Customs Guide

AMG (Arzneimittelgesetz) regulations, import permits, certificates of origin, and compliance requirements

Medium-Risk Destination

Germany applies strict pharmaceutical import controls under the AMG. Customs success rate is approximately 72%. Import permits must be applied for at least 12 weeks in advance.

1. Regulatory Framework

The legal basis for medicinal product legislation in Germany is the Medicinal Products Act (Arzneimittelgesetz – AMG). Customs authorities cooperate in monitoring the movement and introduction of medicinal products and active substances within the scope of the AMG.

In their monitoring, customs offices examine in particular:

•Whether the required import permits, certificates, and certifications have been obtained

•Whether the medicinal products have been approved, registered, or licensed

•Whether labelling requirements have been complied with

•Whether finished medicinal products include a package leaflet in German

2. Import Requirements (Non-EU States)

When importing medicinal products or certain active substances from non-EU states, you always require:

Import Permit (Section 72 AMG)

A formal permit authorizing the import of medicinal products from outside the EU.

Certificate of Origin (Section 72a AMG)

A certificate from the country of origin confirming compliance with quality standards.

Municipal Certification

Appropriate certification from the medicinal products authority competent for commercial imports in the municipality where your business is established.

Note: Imports from Iceland, Liechtenstein, and Norway (EEA member states) can be released for free circulation without the presentation of medicinal product legislation documents.

3. Application Timeline & Costs

Timeline

• Apply for permission at least 12 weeks before the planned import
• In the case of foreign inspections, apply at least 12 months in advance

Costs

Import permit fees range from €200 to €20,000 depending on the tariff category.

4. Key Considerations

•The medicinal product to be imported must be approved in Germany or the EU, or it must be proven that an application for approval has been submitted

•Proper documentation of samples is critical for uncomplicated clearance into the European Union

•Mark samples, if applicable, as: Non‑harmful, non‑radioactive, non‑infectious

5. Compliance Recommendations

✓Contact customs authorities before shipping to prevent import issues

✓Ensure the product is approved in Germany/EU or that an approval application is in progress

✓Apply for import permits well in advance (minimum 12 weeks)

✓Prepare complete documentation: import permit, certificate of origin, COA, GMP certificates

✓Include German‑language package leaflets for finished medicinal products

✓Work with a German customs broker familiar with AMG requirements

Shipping to Germany?

Start your AMG import permit application 12 weeks in advance. Complete German-language documentation is essential.

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