Germany operates the largest regulated medical cannabis market in the EU. The MedCanG (2024) consolidated the legal framework under BfArM oversight. Imports require federal authorization; pharmacies dispense via BtM prescription.
Medical cannabis is legal under the MedCanG (Medizinal-Cannabisgesetz), effective April 1, 2024. This replaced BtMG provisions and created a dedicated framework for medical cannabis separate from recreational use. Cannabis is prescribed as a finished medicinal product or magistral preparation.
Licensing — Who Can Operate
Importers require a BtMG §3 importer license issued by BfArM. Wholesale distributors require an AMG §52a wholesale authorization. Pharmacies dispense under their standard pharmacy license without additional cannabis-specific authorization. German manufacturers require an AMG §13 manufacturing authorization.
Prescription & Patient Access
Patients require a doctor's prescription (BtM-Rezept). There are no approved indications — any indication may be prescribed at physician discretion. Monthly costs are reimbursable by statutory health insurance (GKV) following a 2024 amendment, subject to prior authorization for some conditions.
Product Standards
Permitted forms: dried flower, extracts, oils, and dronabinol preparations. No prescribed THC/CBD limits — product must match approved specifications. Labeling must conform to AMVV and include batch number, expiry, manufacturer name, and composition in German.
Key rule: All imports require a per-shipment BtMG §3 authorization from BfArM. No blanket or annual authorizations are issued.
Import Authorization
Applications submitted via BfArM online portal. Average processing: 5 weeks (reduced from 8 weeks, Feb 2026). Each authorization specifies: exporting country, exporter, importer, quantity, product type, and HS code. Authorization is shipment-specific.
Approved Exporting Countries
Germany accepts imports from all countries with a recognized national cannabis control authority. Israeli cannabis (via INCB procedure) is accepted. Canadian, Dutch, Portuguese, Danish, and Australian cannabis are the dominant import sources.
Required Documentation per Shipment
BtMG import authorization (original), Certificate of Analysis (COA) per batch, EU-GMP or recognized GMP certificate of the manufacturer, GACP certificate of the cultivation site, Phytosanitary certificate (if applicable), Exporting country export authorization, Bill of lading / airway bill.
Customs Classification
HS Code: 1211.90 (plants used in pharmacy). Frankfurt airport (FRA) and Hamburg port are the primary entry points. BfArM import authorization must be presented at customs. Controlled substance import declaration under Single Convention 1961 applies.
Export from Germany
Germany-based manufacturers may export with a BtMG §3 export authorization from BfArM plus import authorization from the destination country. Germany-manufactured product carries EU-GMP Part I status, broadly accepted across EU and PIC/S member states.
Key rule: EU-GMP Part I required for finished products. EU-GMP Part II accepted for bulk API supplied to a German licensed finisher — not for direct finished product import.
EU-GMP Part I — Finished Products
Required for all finished medicinal cannabis (dried flower, extract, oil) imported and dispensed directly to pharmacies. The manufacturing site must hold a valid EU-GMP certificate issued by an EEA competent authority or recognized PIC/S member.
EU-GMP Part II — Active Substance
Accepted for bulk cannabis active substance supplied to a German AMG §13 licensed manufacturer who performs finishing operations under Part I. Primary pathway for Israeli and Canadian bulk suppliers entering the German market.
Non-EU GMP Certificates
Certificates from PIC/S member state authorities (TGA Australia, Health Canada, MHRA UK) are recognized by BfArM. US FDA does not issue EU-GMP certificates — US-origin product requires a separate EU-based QP for batch certification.
Qualified Person (QP) Requirement
Every batch released for the German market must be certified by an EU-qualified Qualified Person named on the manufacturing authorization. For imports, the QP at the importing entity certifies the batch — not the foreign manufacturer's QP.
BfArM Inspection Rights
BfArM may conduct GMP inspections of foreign manufacturing sites. Since 2025, remote assessments are accepted as an initial step for new suppliers, with physical inspection required within 24 months of first import.
Note: GACP is a prerequisite for BfArM import authorization. Both EU GACP and WHO GACP are accepted. Self-certification is not accepted.
Accepted GACP Standards
Germany accepts the EU GACP Guideline (EMEA/HMPC/246816/2006) and WHO GACP 2003. Certification must be issued by an ISO 17065-accredited third-party body.
Recognized Certifying Bodies
Any ISO 17065-accredited body issuing against EU GACP or WHO GACP is accepted. Common bodies: Bureau Veritas, SGS, Kiwa, IQNET members. BfArM reviews accreditation case-by-case.
Certificate Validity & Renewal
Certificates are typically issued for 1–3 years. BfArM requires a current (unexpired) certificate at the time of each import authorization application. No grace periods are granted.
GACP + GMP Chain of Custody
The GACP certificate must name the specific cultivation site. The GMP certificate must reference the GACP-certified source. Any change in cultivation site requires a new GACP certificate and BfArM notification.
No documents yet
No regulatory documents available for this jurisdiction yet. We are expanding coverage — check back later.
Regulator Contacts
BfArM
Federal Institute for Drugs and Medical Devices — Primary cannabis regulator