- GMP Assessment
Determine which GMP pathway applies to your product and manufacturing setup for the German market.
- Finished product or bulk API?
Are you importing finished medicinal product (ready for pharmacy) or bulk active substance (for further processing by a German manufacturer)?
- Need EU-GMP Part I — Finished product path
All finished medical cannabis products must be manufactured under EU-GMP Part I to be imported into Germany.
- Covers full manufacturing to finished product
- Includes QC, release testing, QP certification
- Certificate issued by EEA or PIC/S authority
- Need EU-GMP Part II — Bulk API path
Bulk cannabis API supplied to a German AMG §13 licensed manufacturer. They take Part I responsibility for finishing.
- Covers active substance manufacturing only
- German finisher holds Part I for finishing steps
- Batch release by German QP
- Manufacturer location?
Where is the site? This determines who issues the GMP certificate and whether BfArM accepts it directly.
- EEA Authority Certificate — ANSM, IMB, PEI, AGES…
EEA competent authority issues EU-GMP Part I directly. Gold standard — fully accepted by BfArM with no additional steps.
- ANSM (France), IMB (Ireland), PEI (Germany)
- Certificate directly valid for German import
- All EEA-issued certificates accepted by BfArM
- PIC/S Member Certificate — TGA, Health Canada, MHRA…
PIC/S mutual recognition means BfArM accepts TGA (Australia), Health Canada, MHRA (UK) certificates as equivalent to EU-GMP Part I.
- TGA (Australia) — fully accepted
- Health Canada — fully accepted
- MHRA UK — accepted post-Brexit under MRA
- Certificate must cover cannabis scope
- EU-Based QP Required — Non-PIC/S manufacturers
Manufacturers in non-PIC/S countries (e.g., US) need an EU-based QP to certify each batch. US FDA certificates are not accepted by BfArM.
- QP named on an EU manufacturing authorization
- QP certifies compliance batch-by-batch
- US FDA certificates not accepted by BfArM
- Israeli IMFA certs reviewed case-by-case
- Supply to German Finisher
Under EU-GMP Part II, supply bulk API to a licensed German manufacturer. They handle finishing, QP release, and direct supply to pharmacies.