- GMP Assessment
Determine GMP pathway for Israeli-manufactured cannabis. IMFA-issued GMP certificates are recognised bilaterally by EU, UK, Australia, Canada — a key competitive advantage for Israeli exporters.
- Finished product or API?
Are you manufacturing finished medicinal product (ready for pharmacy) or bulk API/extract for further processing by the importing country's manufacturer?
- EU-GMP Part I Path — Finished product for EU/UK
For supply of finished product to Germany, Netherlands, and other EU markets — EU-GMP Part I required. Most major Israeli manufacturers hold EU-GMP Part I issued by ANSM (France), IMB (Ireland), or other EEA authority.
- EU-GMP Part I certificate from EEA authority
- Cannabis scope explicitly stated on certificate
- QP at Israeli site or at EU importing entity
- IMFA GMP inspection in parallel for Israeli market
- IMFA GMP Certificate Path — For UK, Australia, Canada
IMFA-issued GMP certificates are accepted directly by MHRA (UK), TGA (Australia), and Health Canada under bilateral arrangements. No additional EU-GMP inspection needed for these markets.
- IMFA GMP inspection conducted
- IMFA certificate covers cannabis manufacturing scope
- Certificate accepted by MHRA, TGA, Health Canada directly
- Bilateral recognition — no re-inspection required
- EEA Authority Inspection
ANSM, IMB, or other EEA authority conducts EU-GMP Part I inspection of the Israeli site. Israeli manufacturers with EU-GMP Part I are the gold standard for the German and Dutch markets.
- Site must meet EU-GMP Annex 1 (sterile) or main guide
- Inspection fee paid to inspecting authority
- IMFA may conduct joint inspection in some cases
- IMFA Inspection
IMFA conducts its own GMP inspection. IMFA certificate issued. Accepted bilaterally by MHRA, TGA, Health Canada.
- Annual IMFA GMP inspection
- Cannabis-specific manufacturing scope
- IMFA certificate validity: typically 2–3 years
- EU-GMP Part I Certified ✓
Eligible to supply finished product to Germany, Netherlands, Czech Republic, and all EU markets that require Part I.
- IMFA GMP Certified ✓
Eligible to supply UK, Australia, Canada directly. Also valid for Israeli domestic market.