- Product for Israeli Market
Product intended for the Israeli domestic medical cannabis market. IMFA maintains a product registry — all domestically sold products must be registered.
- Hold IMCA Manufacturing License
IMFA-issued IMCA license with manufacturing scope required. License specifies permitted product forms (dried flower, extract, oil, capsule, etc.).
- IMCA manufacturing license
- Product forms must match license scope
- Facility must pass IMFA GMP inspection
- Prepare Product Dossier
IMFA requires product specifications, analytical methods, stability data, and GMP documentation for each registered product.
- Product name, form, THC/CBD content
- Batch manufacturing record template
- Analytical specifications (HPLC, microbiology)
- Stability data per IMFA guidance
- Labeling in Hebrew (mandatory)
- IMFA Product Registration
Submit product dossier to IMFA for registration. IMFA assigns a registration number. Processing: 4–12 weeks for new products.
- Registration granted?
IMFA approves or requests additional information. Common issues: stability data gaps, labeling non-compliance, or analytical method validation gaps.
- Address IMFA Queries
Provide additional stability data, analytical method validation reports, or revised labeling as requested.
- Respond within IMFA-specified timeframe
- Updated labeling must comply with IMFA labeling directive
- Product Registered
IMFA registration number issued. Product may be supplied to licensed dispensaries and pharmacies.
- Registration number on all product labeling
- Annual renewal of registration required
- Any formulation changes require IMFA variation approval
- Patient Quota System
Israeli patients receive a monthly gram quota from MOH. Products are prescribed against this quota. IMFA tracks supply chain from manufacturer to patient via electronic system.
- IMFA electronic tracking system compliance
- Monthly reporting to IMFA
- Quota changes require MOH approval
- Domestic Supply Active ✓
Product available to ~120,000 licensed Israeli patients via IMFA-licensed dispensaries and pharmacies.