- Shipment Planned
Both the BfArM import authorization and exporting country export authorization must be in hand before shipment departs.
- Exporting Country Auth
Obtain export authorization from the national authority of the exporting country (e.g., IMFA in Israel, ODC in Australia).
- Names German importer by license number
- Quantity and product description matching BfArM auth
- Per-shipment — no blanket export authorizations
- BfArM Import Auth
Per-shipment BtMG §3 authorization from BfArM must be received before shipment departs origin country.
- Original document required at customs
- Must be received before departure
- Prepare Shipping Docs
Full documentation package required by German customs.
- Original BtMG import authorization
- COA per batch
- EU-GMP + GACP certificates
- Phytosanitary certificate (if applicable)
- Airway bill / bill of lading
- Commercial invoice with HS code 1211.90
- Shipment Departs
Freight forwarder arranges controlled substance shipment. Air freight is primary (Frankfurt FRA). Sea freight via Hamburg port.
- Customs Entry — FRA / Hamburg
Customs broker presents BtMG authorization and documentation. Controlled substance declaration filed under Single Convention 1961.
- Original import authorization presented at entry
- BtMG import declaration form completed
- Physical inspection may be triggered
- Physical inspection?
German customs may select consignments for physical inspection. Higher probability for new suppliers or large shipments.
- Physical Inspection
Customs officers verify product against documentation. Batch numbers, quantities, and product identity checked. Allow 1–3 additional days.
- Product must match authorization exactly
- Discrepancies result in hold — notify BfArM
- Customs Cleared
Duties paid (if applicable). Import authorization endorsed. Cannabis released to licensed German importer.
- Receipt Testing & QP Release
German importer's QP performs receipt testing and certifies each batch against EU-GMP requirements.
- Identity and potency per pharmacopoeia
- Microbiological testing
- QP signs and dates batch certificate
- Released to Pharmacy Supply ✓
Batch QP-certified. Available for wholesale distribution to pharmacies ordering against BtM prescriptions.