Importing Pharmaceuticals into Germany: A Practical Guide
Germany is the largest pharmaceutical market in the EU and a primary entry point for products moving into Europe. Its import regime has a feature that surprises newcomers: while the federal agencies sit at the top, the licences and inspections that actually gate an import are run by the individual federal states, the Länder. This guide covers the German Medicines Act framework, what an importer needs from a third country versus within the EU, how investigational product moves, and where consignments get held.
Who regulates pharmaceutical imports into Germany
Medicines in Germany are governed by the German Medicines Act (Arzneimittelgesetz, AMG). Marketing authorisations are granted nationally by BfArM, the Federal Institute for Drugs and Medical Devices, or, for biologicals such as vaccines and blood products, by the Paul-Ehrlich-Institut, and centrally across the EU by the EMA. The licences that matter for import and distribution, the manufacturing and import authorisation and the wholesale authorisation, are issued and inspected by the competent authority of the relevant federal state (Land), not by the federal agencies.
Where the product comes from changes everything. From another EU or EEA member state, movement is intra-community with no customs import, but good distribution practice still applies. From a third country, the goods are customs-imported and, for medicinal products, require an import authorisation and Qualified Person certification before release.
What the importer needs
- A manufacturing and import authorisation under the AMG for import of medicinal products from third countries.
- Qualified Person (QP) certification. A QP certifies each imported batch before it can be released in the EU.
- A wholesale distribution authorisation and GDP compliance for onward distribution.
- Customs clearance for third-country imports, with the commercial or proforma invoice and correct tariff classification.
- Serialisation. Authorised medicines carry Falsified Medicines Directive safety features, verified through the German securPharm system.
| Document | Purpose |
|---|---|
| Manufacturing and import authorisation | Evidence the importer may import medicinal products. |
| QP batch certification | Confirms the batch is released for the EU market. |
| GMP certificate | Manufacturing quality evidence for the batch. |
| Wholesale authorisation and GDP evidence | Authorises onward distribution under GDP. |
| Commercial or proforma invoice | Customs valuation and description. |
| Temperature record | Cold-chain evidence for temperature-sensitive products. |
Clinical trial material
Clinical trials in the EU run under the Clinical Trials Regulation (536/2014) through the Clinical Trials Information System. Import of investigational medicinal product into the EU, including Germany, requires a manufacturing and import authorisation for IMPs and QP certification of each imported batch. The trial itself needs authorisation through CTIS and a favourable opinion from an ethics committee before material moves.
Cold chain and special categories
- Cold chain. Continuous temperature data and a documented excursion response are expected under GDP.
- Narcotics. Controlled substances fall under the German Narcotics Act and need separate authorisation and permits.
- Dangerous goods. Dry ice and certain biologicals require the correct transport declaration.
Where shipments get held up
- 1A third-country import arrives without the required import authorisation or QP certification.
- 2The batch cannot be QP-certified because GMP or batch documentation is incomplete.
- 3Serialisation data does not verify against securPharm for an authorised medicine.
- 4Temperature data has a gap, forcing a quality decision.
- 5The wrong Land authority has been engaged, or the wholesale authorisation does not cover the activity.
Frequently asked questions
Yes. Import of medicinal products from a third country requires a manufacturing and import authorisation under the German Medicines Act and Qualified Person certification of each batch before release, plus a wholesale authorisation and GDP compliance for onward distribution. These licences are issued by the competent authority of the relevant federal state.