Israel's Medical Cannabis Quality Standards (IMC-GMP)

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. Our profile of Bedrocan and the Dutch standardisation model sets out how that batch-to-batch consistency was actually achieved, and why it is the half of the story Israeli laboratory science did not supply.

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.

The procedure also puts numbers on "purity". In the January 2022 text of Procedure 152 (update 4) the Ministry of Health sets maximum heavy-metal levels of 0.5 ppm for cadmium, 5.0 ppm for lead, 0.1 ppm for mercury and 2.5 ppm for arsenic, caps aflatoxin B1 at 2 µg/kg and total aflatoxins at 4 µg/kg, limits foreign matter to 2% by mass and sets a target moisture level of 10%, with up to 4% deviation (Ministry of Health, Procedure 152, update 4). Cannabinoid content is reported "on a dry basis" and must count the acid forms too — total THC is calculated as THC plus 0.877 × THCA — so the figure on the label reflects the potency of the dried product rather than whatever water it happens to contain (Procedure 152). Pesticide use is limited to the list of substances the Ministry of Agriculture and the Medical Cannabis Unit publish, and residue testing has to be done in laboratories approved by the Ministry of Agriculture and accredited to ISO 17025 (Procedure 152).

Reading the label: what IMC-GMP requires on the pack

For a patient, the most practical part of the standard is what it forces onto the packaging. Under the January 2022 text of Procedure 152, every medical cannabis product must be labelled with at least (Ministry of Health, Procedure 152, update 4):

• the generic product name and its category from the procedure's product tables;
• the exact THC, CBD and CBN concentrations measured in that production batch — not a typical value for the strain;
• every ingredient that is not cannabis — for an oil, the type of carrier oil;
• the words "dangerous drug" in red;
• a QR code linking to the batch certificate online;
• the harvest, processing and packing months, and the growing and production batch details;
• the name of the licence holder or holders for growing, processing and packing;
• the expiry date and storage conditions;
• standard icons for any physical or chemical treatment applied during growing or production — the procedure's own example is irradiation — explained in a key in the product leaflet.

The first four items must appear in at least Hebrew and English, in bold. Brand names, the grower's name and strain names are allowed on top, but the procedure says no marking may mislead the public about the product or its properties (Procedure 152).

The batch certificate behind the QR code. Each production batch released to a wholesaler carries a certificate signed by the manufacturer's designated batch-release officer, listing the production and expiry dates, batch number and size, the manufacturing and testing site, the measured cannabinoid concentrations, the specifications and the test results against them, and the storage conditions. The procedure requires that certificate to be handed to the buyer and published on the manufacturer's website for public transparency (Procedure 152). In practice, that means the laboratory results for the exact batch in your hand should be one scan away.

Pack size and shelf life. The procedure defines the three standard product forms — dried flower, rolled flower (pre-rolls) and cannabis oil — as packs of 10 grams net each; for oil, that is 10 grams of extract already diluted in oil (Procedure 152). This is why pharmacy prices in Israel are quoted per 10 grams; our guide to what medical cannabis costs in Israel works through what that means for a monthly bill. By default a product's expiry date is set at six months from packing, unless the manufacturer submits stability data the unit approves for a longer period, and production should start within a year of harvest on the same condition (Procedure 152).

Who made it. The licence holders named on the label are the companies that grew, processed and packed the product. The licensed producers, manufacturers and suppliers in Israel's supply chain are listed in our directory of Israeli cannabis companies, with fuller profiles of the larger players on our companies hub. How to check a producer's licence status, batch certificates and withdrawal record is set out in how to compare Israel's medical cannabis producers.

What the stamp does not mean. IMC-GMP is a standard for consistency and purity, not a finding that a product works. The procedure itself opens by stating that cannabis is not a medicine, is not registered as a drug, and that its efficacy and safety for medical use have not yet been proven — the aim of the standard is to make the supply chain as close as possible to that of registered medicines (Procedure 152). Whether a product is appropriate for a particular patient is a question for the treating physician.

Which version applies. The details above are drawn from update 4 of Procedure 152, published in January 2022. The Ministry's page for the procedure lists a later revision, update 5, dated 2 April 2024 (Ministry of Health); where the two differ, the current revision governs.

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.

The procedure spells out how that works for manufacturers. An IMC-GMP approval is issued by the Medical Cannabis Unit after an audit by the unit or an inspection body it has authorised; it is valid for up to three years and can be renewed for further periods of up to three years each, with the renewal application due at least 120 days before expiry. The unit or the inspection body carries out both periodic and unannounced inspections. Every plant must employ a responsible pharmacist, a batch-release officer and a quality-assurance manager, each approved by the unit — one person may combine two of those roles with the unit's approval, but never all three — and no batch may be marketed until the batch-release officer and the responsible pharmacist have signed off on it. The approval is a precondition for a manufacturing licence under the Dangerous Drugs Ordinance, not a licence in itself (Ministry of Health, Procedure 152, update 4).

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?.