Israel

Israel was among the first countries to establish a formal medical cannabis program, beginning in the 1990s and formalised under the Dangerous Drugs Ordinance with MOH directives. The current IMFA framework, established ~2016–2020, brought industrial-scale regulation. Cannabis is legal for medical use only — recreational use remains illegal.

The Israel Medical Cannabis Agency (IMFA), under the Ministry of Health, is the primary regulator. IMFA issues all IMCA licenses, conducts GMP and GACP inspections, issues per-shipment export permits, and manages the domestic patient quota system. IMFA is internationally recognized — its GMP certificates are accepted by EU, UK, Australia, and Canada.

~120,000 licensed patients as of 2026. Patients receive a monthly gram quota (up to 40g/month following the Nov 2025 increase). Prescriptions issued by authorized physicians. Products dispensed through IMFA-licensed pharmacies and specialized dispensaries. GKV-equivalent reimbursement does not apply — patients pay out of pocket or via private insurance.

Israel is a major global cannabis exporter with a mature, internationally recognized regulatory framework. IMFA GMP certificates are accepted bilaterally by MHRA (UK), TGA (Australia), Health Canada, and under MRA arrangements with the EU GMP network. Germany and the UK are the largest Israeli export destinations.

IMCA licenses are issued per activity: cultivation, manufacturing (finished product and/or extract/API), distribution, dispensing, import, and export. A single entity may hold multiple license types. Currently ~120 licensed entities with ~60 active manufacturers.

IMFA has been actively updating its export documentation requirements and expanding bilateral GMP recognition agreements. Monitor IMFA directives closely — changes in 2025–2026 have affected export documentation requirements and product registration procedures.

IMFA issues per-shipment export permits under the Dangerous Drugs Ordinance. Applications submitted with the destination import authorization attached. Processing: approximately 2–3 weeks once destination auth is in hand. IMFA cross-checks all product details with the destination document.

Germany (BfArM): ~5 weeks. UK (Home Office): ~10 working days. Australia (TGA + ODC): 4–8 weeks. Netherlands (CCBM): ~4 weeks. Canada (Health Canada): ~4 weeks. Total supply chain planning should allow 8–12 weeks from intent to shipment for new trade lanes.

IMFA export permit (original), IMFA GMP or EU-GMP certificate, GACP certificate, Certificate of Analysis (COA) per batch with QP signature in English, Airway bill, Exporting country customs declaration, INCB narcotic export notification (filed by IMFA).

Virtually all Israeli cannabis exports depart via Ben Gurion Airport (TLV). Israeli Airports Authority has established procedures for pharmaceutical/narcotic exports. GDP-compliant handling available. Cold chain for temperature-sensitive products. Notify freight forwarder at least 72 hours before planned departure.

Israel imports relatively little cannabis given its large domestic industry. Foreign manufacturers must appoint an Israeli IMCA-licensed importer. IMFA product evaluation required before first import. Per-shipment import authorization issued by IMFA. Market entry is niche — focus on products or varieties not produced domestically.

HS Code: 1211.90 (plants and parts of plants used in pharmacy). Israeli Customs Authority processes narcotic import/export declarations under Single Convention 1961. IMFA files quarterly INCB reports covering all Israeli exports and imports.

IMFA conducts GMP inspections to a standard aligned with EU-GMP (PIC/S member equivalent). IMFA-issued GMP certificates are accepted by MHRA, TGA, and Health Canada under bilateral arrangements. Certificate validity: typically 2–3 years.

For finished product export to Germany, Netherlands, Czech Republic, and other EU markets requiring Part I — Israeli manufacturers typically obtain EU-GMP Part I certification from an EEA authority. Most common: ANSM (France) and IMB (Ireland) conduct inspections in Israel. Certificate is valid across all EU member states.

Israeli manufacturers supplying bulk API or extract to EU-licensed finishers may hold EU-GMP Part II. This allows supply to a German AMG §13 licensed finisher who takes responsibility for finished product Part I compliance.

Most export-oriented Israeli manufacturers hold both IMFA GMP and EU-GMP Part I — giving them access to all major markets (EU, UK, Australia, Canada) with a single manufacturing site. This dual certification is the industry standard among top Israeli exporters.

Batches exported to EU markets must be certified by an EU Qualified Person. For Israeli sites: either a QP employed at the Israeli site (holding EU QP qualifications) or a QP at the EU importer certifies each batch. The QP signature on the COA is required for EU customs clearance.

All Israeli cannabis cultivation sites must comply with GACP as a condition of their IMCA cultivation license. IMFA accepts EU GACP (EMEA/HMPC guideline) and WHO GACP 2003. Third-party ISO 17065-accredited certification required — IMFA does not accept self-certification.

IMFA conducts periodic announced and unannounced inspections of cultivation sites. Inspection frequency is risk-based. Non-compliance can result in license suspension. IMFA inspection findings are not publicly disclosed — exporters should maintain continuous compliance.

Importing countries (Germany BfArM, UK MHRA, Australia TGA) require a current GACP certificate as part of import permit applications. The certificate must name the specific cultivation site. Any change in site requires a new certificate and notification to all importing country authorities.

GACP certificates are typically issued for 1–3 years. IMFA requires current certificates for license renewal and export permit applications. Build renewal audits into annual planning — certificate lapses have caused shipment delays for Israeli exporters.

IMFA requires cultivation sites to document cannabis varieties by registered name and genetic profile. Variety changes require IMFA notification and may require GACP re-audit if cultivation conditions differ significantly. Important for maintaining consistency of exported product specifications.