IMC-GAP and IMC-GMP: Israel's Medical Cannabis Standards Explained

Every legal medical cannabis product in Israel carries an "IMC – Medical Grade" stamp. Behind that label sits a four-part rulebook that governs the entire supply chain, from the seedling in the greenhouse to the jar on the pharmacy shelf. This guide explains what the IMC standards are, what each one requires, and why they matter far beyond Israel's borders.

Where the standards came from

For its first two decades, Israel's medical cannabis programme ran on individual permits with little standardisation. That changed with government resolution #1587 of June 2016 — the "medicalization" reform — which set out to turn a patchwork of approvals into a regulated, pharmaceutical-style industry (PMC review, 2011–2025). The centrepiece was a suite of binding quality standards published that autumn and adopted by official resolution, administered by the Health Ministry's Medical Cannabis Unit — known by the acronym IMCA or the Hebrew "Yakar."

The standards are deliberately modelled on European pharmaceutical practice rather than invented from scratch. They borrow the structure of EU Good Manufacturing Practice and the European Pharmacopoeia, which is why Israeli-grown cannabis can credibly target regulated export markets.

The Dutch precedent

Israel did not invent the idea of pharmaceutical-grade cannabis — it adopted a model pioneered in the Netherlands. The Dutch were the first country in Europe to build a state medical-cannabis system with domestic production, run since 2003 through the government's Office of Medicinal Cannabis (OMC), which takes possession of the harvest and handles export on behalf of the Ministry of Health (Bedrocan). The sole grower behind that system, Bedrocan, became the first company in the world to obtain EU-GMP certification for medicinal cannabis, in 2017 (Bedrocan), proving that cannabis flower could be produced as a standardised, batch-consistent active pharmaceutical ingredient. That proof of concept — standardised varieties at defined THC/CBD ratios, dispensed by prescription and exported under GMP — is the template Israel's IMC standards follow. The Netherlands is also, notably, among the markets that have exported flower into Israel.

The four IMC standards

The framework breaks the supply chain into four domains, each with its own standard and its own Health Ministry directive (BH Synergy Group):

IMC-GAP — Good Agricultural Practice. Set out in Directive 151 (SOP 151), this governs propagation, cultivation and harvesting. It is the cannabis-specific application of the internationally recognised GACP (Good Agricultural and Collection Practice) framework for plant-derived medicines, covering everything from mother-plant management and pesticide control to harvest timing and record-keeping (Gamson, IMC-GAP launch).

IMC-GMP — Good Manufacturing Practice. Set out in Directive 152 (SOP 152), this is the heart of the system. It defines the tests and specifications every product must meet before it can be marketed, and those requirements are built on the European Pharmacopoeia's General Monograph for Herbal Drugs (Ph. Eur. 1433) and EU-GMP Annex 7 on herbal medicinal products (Gsap). In practice, post-harvest steps such as drying, curing, trimming, extraction and packaging are treated like pharmaceutical manufacturing.

IMC-GDP — Good Distribution Practice. Governs storage and distribution — the cold chain, transport conditions, traceability and stock control that keep a finished product within spec until it reaches the patient.

IMC-GSP — Good Security Practice. Governs the physical security of sites handling a controlled substance: access control, surveillance, inventory reconciliation and anti-diversion measures.

What IMC-GMP actually tests

The GMP standard is where abstract "quality" becomes concrete numbers. Under SOP 152 and the January 2019 product notification, Israel recognises four main product groups — inflorescences (flower), cigarettes (pre-rolls), oils, and cookies — with defined sub-products that differ by cannabinoid concentration and, for THC flower, by genetic source (sativa or indica) (Gsap). Twelve inflorescence products and nine oil products are specified, each with its own labelled potency band.

Because the tests follow the European Pharmacopoeia herbal-drug monograph, products must be analysed for cannabinoid assay (the actual THC and CBD content must fall within a tight band of the labelled amount), plus microbiological contamination, heavy metals, pesticide residues and other impurities. The logic mirrors any herbal medicine: a patient should get the same potency and purity from every batch, every time.

How the pieces fit together

The standards map onto the plant's journey. Cultivation and harvest fall under IMC-GAP/GACP. The moment cannabis becomes "starting material" for a medicine — once it is dried, cured and trimmed — the stricter GMP requirements of EU-GMP begin to apply, because those steps influence the finished product (Gsap). Manufacturing, testing and release sit squarely under IMC-GMP. Storage and transport fall under IMC-GDP, and security wraps around the whole chain under IMC-GSP. A licensed operator typically needs to demonstrate compliance across every relevant standard, verified by Health Ministry inspection, before a product can be marked IMC – Medical Grade and dispensed.

Certification and inspection

Compliance is not self-declared. When IMC-GAP launched, the Health Ministry approved specific certification bodies to audit propagation and cultivation sites against the standard (Gamson, IMC-GAP launch), and operators across the chain must demonstrate conformity through documentation and on-site inspection before a licence is granted or renewed. A facility that fails to hold its conditions — a contamination result out of spec, a broken cold chain, a security lapse — risks product being rejected at batch release or its licence being suspended. For producers, the practical consequence is that quality assurance is a continuous obligation, not a one-time certificate, and it is the single biggest fixed cost of operating inside the legal framework rather than the illicit market.

Why the standards matter for export

This pharmaceutical framing is not just domestic housekeeping — it is Israel's competitive case abroad. Regulated importers such as Germany require EU-GMP certification before cannabis can enter the market, and the IMC system was built to be intelligible to exactly those regulators. By aligning early with European Pharmacopoeia and EU-GMP structures, Israeli producers positioned themselves to supply markets that reject loosely regulated product. The standards are, in effect, the quality passport behind the country's export ambitions — and a key reason Israel is taken seriously as a medical-cannabis origin rather than just a consumer market.

This guide is general information about Israel's regulatory standards, not medical or legal advice. Always rely on a qualified physician and pharmacist for treatment decisions, and verify current requirements with the Israeli Ministry of Health.

The takeaway

The IMC standards turned Israeli medical cannabis from a permit programme into a regulated pharmaceutical supply chain: IMC-GAP for growing, IMC-GMP for making and testing, IMC-GDP for moving and storing, and IMC-GSP for securing. Together they are why every legal product is batch-tested to a published spec and stamped "Medical Grade." For how these standards fit into the wider rulebook, see our Regulation hub, the medical cannabis reform timeline, and is cannabis legal in Israel?.