Every country that supplies cannabis to patients legally has had to choose between two options. It can treat cannabis as a medicine, handled by the normal medicines regulator. Or it can treat cannabis as a special case with its own government agency. That choice affects you as a supplier in three ways: who buys from you, which certificates you need, and whether an import quota limits how much you can sell.
This article covers the international rules, not Thai law. In Thailand, cannabis flower is a controlled herb under the Notification of the Ministry of Public Health Re: Controlled Herbs (Cannabis), B.E. 2568. It is dispensed with a prescription on form PT 33 (ภ.ท.33). The Thai rules are explained in the topic on Thailand’s cannabis rules, 2022 to 2026. Nothing below says what is allowed in Thailand.
Translator’s note: Here are the main points of Thai law for readers who need them. The B.E. 2568 Notification was issued under the Thai Traditional Medicine Protection Act B.E. 2542 and came into force on 26 June 2025. A PT 33 prescription covers at most 30 days. Advertising and online sale of cannabis flower are prohibited. The penalty under section 78 of the 1999 Act is up to 1 year in prison, a fine of up to 20,000 baht, or both. The draft Cannabis Control Act is not law yet: the Cabinet approved the draft on 22 September 2026 and sent it to the House.
1. The International Treaty That Comes Before National Law
Every country designs its own system inside limits set by a treaty. The Single Convention on Narcotic Drugs, 1961, is the main UN treaty on controlled drugs such as opium, cocaine and cannabis. Three parts of this treaty shape every national medical cannabis programme.
Article 4: medical and scientific use only
Article 4 allows controlled drugs only for medical and scientific purposes. This covers every step: production, manufacture, trade, distribution, use and possession.
The treaty is supervised by the International Narcotics Control Board (INCB), a body based in Vienna. Based on Article 4, the INCB has stated many times that legalising non-medical cannabis use breaks the Convention.
Articles 23 and 28: a government agency wherever cultivation is allowed
These articles were first written for opium and were later applied to cannabis too. A country that allows cannabis cultivation must name one government agency. That agency must:
- license the people who grow the crop;
- take physical possession of the entire harvest within four months after harvest ends;
- hold the exclusive right to wholesale trade, stocks, import and export.
Article 28 contains an important exception. The Convention does not apply to cannabis grown only for industrial purposes (fibre and seed) or horticultural purposes. This exception is the treaty basis for the industrial hemp sector.
Translator’s note: The hemp exception is part of the treaty. Each country’s own law still decides what counts as hemp and what may be exported. What can leave Thailand as hemp is covered in What Can Actually Leave Thailand as Hemp: Extracts, Seed, Fibre and Cosmetics.
Articles 19 to 21: the yearly estimate
Each year, every country sends the INCB an estimate of how much of each controlled drug it needs for medical and scientific use. The INCB confirms these estimates, runs the system and tracks the drug flows between countries. Countries also report what they actually produced, imported and used.
The estimate sets a limit. A country may not manufacture and import more in a year than its estimate allows. Under Article 19, a country whose annual estimate turns out too low can file a supplementary estimate (an extra request during the year).
For an exporter, this means demand alone does not decide how much you can sell. The importing country’s current estimate decides it. The estimate can be raised, but only through this formal process.
The 2020 change, and what it did not change
The treaty sorts drugs into lists called schedules, and each schedule carries a different level of control. On 2 December 2020, the Commission on Narcotic Drugs (CND) voted on a recommendation from the World Health Organization (WHO). The CND is the UN commission where member states vote on how drugs are scheduled. It voted to remove cannabis and cannabis resin from Schedule IV.
Schedule IV was the strictest list. It was kept for substances seen as especially dangerous and of little medical value. Cannabis is still in Schedule I, so all the controls of the Convention still apply. The vote removed a symbolic and practical barrier to medical research and use. It did not take cannabis out of control. News reports often get this wrong.
Translator’s note: Before you sign any export deal, ask the buyer for two things in writing. First, the import permit issued by their national authority. Second, confirmation that your volume fits inside their country’s current estimate. The purpose is to find out early whether the order can legally be delivered. The INCB publishes the estimates on its website (see References). Since July 2025 it has also published monthly updates of the cannabis cultivation and production estimates, country by country.
2. Model One: A Separate Cannabis Agency
In this model, the state creates or names a body that handles cannabis apart from other medicines. This agency licenses growers, contracts production, controls the supply chain, and manages import and export. Cannabis gets its own rules on who may prescribe it, dispense it, grow it and hold stock.
The main advantage is that one agency directly meets the treaty requirement in Articles 23 and 28. It also lets a country build a supply chain fast, without waiting for each cannabis product to pass normal medicine registration.
The main cost is a second, parallel system. Cannabis sits outside the normal pharmaceutical system, with its own exceptions and its own paperwork. It is also often more exposed to political change.
3. Model Two: The Normal Medicines Route
In this model, cannabis products follow the same route as any other medicine. The medicines regulator registers a product after reviewing data on quality, safety and efficacy. Doctors then prescribe it, and ordinary pharmacies dispense it.
The advantage is consistency. A registered product has:
- an approved indication (the medical condition it is approved to treat);
- an approved dose;
- a package leaflet for patients;
- a duty of pharmacovigilance (collecting and reporting side effects after sale);
- a named manufacturer that is legally responsible for it.
The cost is that this route is slow and covers few products. Most cannabis products have not been through the normal development route, including clinical trials. That is exactly why cannabis does not fit neatly into either model. Few cannabinoid medicines are registered, and in most countries herbal cannabis flower is not one of them.
Both models aim at the same goal: high standards of quality, safety and efficacy. They differ in how they reach it, not in what they aim for. Most countries mix the two. An agency handles supply, and the medicines regulator handles registered products in parallel.
For each market you are considering, write down two names: the body that licenses cannabis supply, and the body that registers medicines. You will then know who your real customer is and whose rules your product must meet.
4. Real Examples
- Netherlands (agency model). The government’s Office of Medicinal Cannabis has carried out the Single Convention duties for cannabis since 1 January 2001. It holds the monopoly on supplying medicinal cannabis to pharmacies and on import and export. Pharmacies began dispensing it on prescription in 2003. This makes it one of the longest-running pharmacy-based programmes. How Dutch doctors and pharmacists share the work is explained in a separate forum topic.
- Germany (mixed model). In 2017, Germany set up a Cannabis Agency inside BfArM, the federal medicines regulator. The agency awards domestic cultivation contracts by tender and takes possession of the harvest. It then sells the harvest to manufacturers, wholesalers and pharmacies. Imports continue under separate BfArM permits.
- South Korea (registered medicines only). South Korea’s amended narcotics law took effect in March 2019. Press reports at the time said patients may only get cannabinoid medicines already approved in other countries. Examples are Epidiolex, a cannabidiol (CBD) medicine for certain severe epilepsies, and Sativex, a THC–CBD mouth spray. These are imported through a state centre for orphan drugs (medicines for rare diseases). Unapproved extracts and flower remain illegal.
Translator’s note: South Korea shows that a nearby Asian market may accept only registered finished medicines. In such a market, a farm selling flower or crude extract has no direct customer. Before you spend time on a market, check which of these three patterns it follows. The article Five Medical Flower Markets Compared: Germany, Australia, Switzerland, the UK and Israel is a good starting point.
5. Opium Shows the System Can Work
One argument for this system is that it already works for a group of drugs with higher acute risk than cannabis.
Under the UN treaties and national law, opium poppy is grown in Tasmania, an island state of Australia. The crop is shipped to pharmaceutical factories around the world. Hospital and community pharmacies then dispense it as codeine, morphine or oxycodone. Each step is tightly controlled: growing, manufacturing, distribution and dispensing.
Applying this system to cannabis mostly means extending rules that already exist, not inventing new ones. This explains why many cannabis requirements look like the rules for opioid medicines. Whether each of those rules really suits cannabis is still a fair question.
When a cannabis requirement in a target market seems unusually strict, ask the authority or importer which rule text it comes from. Often it is a rule copied from opioid medicines. Knowing this tells you to prepare the same documents a pharmaceutical supplier would.
6. When the Legal Route Is Hard to Use, Patients Go Elsewhere
Whichever model a country chooses, it only works if patients can actually get the product. Some programmes have few doctors trained in or willing to prescribe cannabis. In others the legal channel is hard to reach. In both cases patients do not stop using cannabis.
Many patients then buy illegal or semi-legal products that nobody has tested. Their strength is unpredictable and contamination is a real risk. A programme that is legally correct but hard to use does not end patient use. It pushes that use to untested supply. A business plan should count this demand rather than assume it away.
Translator’s note: The same logic applies in any country where flower needs a prescription. If you run a farm or a licensed dispensary, list the steps a patient must take to buy from you legally. Every extra step shows where buyers may be lost to untested sources. Also give every batch a lab certificate of analysis (COA, the lab report on potency and contaminants). The purpose is to prove your product is the tested, safer option.
7. What This Means for Your Business
If you build a cannabis business in Asia, the model a target market uses decides four practical things.
| Question | Under a cannabis agency | Under the medicines route |
|---|---|---|
| Who is the customer? | The agency, or licensed importers and wholesalers it authorises | A pharmaceutical company holding a marketing authorisation (the licence to sell a registered medicine) |
| What must the product be? | Standardised herbal material that meets the agency’s specification | A registered medicine with a dossier (the full file of quality, safety and efficacy data) |
| Which certificate is needed? | GACP (good agricultural and collection practice) for the farm, plus GMP (good manufacturing practice) for the processing step | Full GMP, backed by a marketing authorisation |
| What limits the volume? | The national estimate filed with the INCB | The estimate, plus the number of patients with the approved condition |
Under both models, the national estimate sets the maximum volume before any price talks begin. A supply contract larger than the importing country’s estimate is more than a commercial risk. It cannot be delivered until that country raises its estimate, for example through a supplementary estimate confirmed by the INCB.
Translator’s note: A Thai or Southeast Asian farm that wants to export can start with these steps:
- Pick one or two target markets and identify their model. The purpose is to know who your buyer is.
- Check the volume against the importing country’s estimate, as described in section 1. The purpose is to avoid signing an order that cannot legally be shipped.
- Plan certification. Under the agency model a GACP farm can supply directly, but the processing step still needs GMP. Under the medicines route you will usually supply a GMP-certified manufacturer, not the market itself.
- Check the Thai side. Exporting also needs Thai permits. Ask the Thai authorities which ones apply to your product before you sign. The Export Pathway: From a Thai Farm to a Regulated Overseas Market describes the export pathway.
- If your product is an extract above 0.2% THC, check who may hold the licence. Under the Ministerial Regulation on Cannabis or Hemp Extracts B.E. 2569 (in force 26 April 2026), only three kinds of holder qualify: Thai juristic persons that are not “foreign” under the Foreign Business Act B.E. 2542, state agencies, and the Thai Red Cross Society. Under the Ministerial Regulation on Controlled Herbs (No. 2) B.E. 2569 (in force 30 April 2026), licence criteria for flower are stricter. Both are explained in Thailand’s Two Ministerial Regulations of B.E. 2569: What Actually Changed for Cannabis Businesses in April 2026.
8. Where the Field Is Heading
One change in wording reflects a real change in thinking. The term “medical cannabis” is slowly being replaced by “cannabinoid therapy”. This term defines the products by their compounds, not by the plant: THC, CBD and other components such as terpenes.
The new term follows how scientific understanding developed. Research moved from the plant itself to the endocannabinoid system, the body’s own signalling system. That system includes receptors, endocannabinoids made by the human body, and phytocannabinoids made by the plant.
The change also matters for regulation. The closer a product moves from herbal material to a defined compound with a dossier, the better it fits the medicines route. It then needs a special agency less. Is that progress, or a narrowing of options? It depends on whether whole-plant preparations have effects that isolated compounds lack (often called the entourage effect). Science has not settled this yet.
Translator’s note: For a grower, this trend means buyers increasingly value consistent, measured chemistry. In Thailand you can start now with no new equipment. Send samples from every batch for cannabinoid and terpene testing, and keep the results in one table per cultivar. After several harvests, the table shows whether your product is consistent enough to supply a manufacturer working toward registered products.
Share Your Experience
Have you dealt with a licensing authority in any Asian market? It could be an application, an import permit, a quota question or a refusal. Please post the details below this topic: what documents they asked for and how long each step took. Real procedures help other growers more than any published summary.
References
- Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol — Arts 4, 19–21, 23, 28 (UN Treaty Collection): https://treaties.un.org/doc/Treaties/1975/08/19750808%2006-05%20PM/Ch_VI_18p.pdf
- UNODC, “CND votes on recommendations for cannabis and cannabis-related substances” (2 December 2020): CND Votes on Recommendations for Cannabis and Cannabis-Related Substances
- INCB, Estimated World Requirements for Narcotic Drugs: Narcotic Drugs Estimates
- Office of Medicinal Cannabis (Netherlands): https://english.cannabisbureau.nl/
- BfArM press release on the Cannabis Agency (2017, German): https://www.bfarm.de/SharedDocs/Pressemitteilungen/DE/2017/pm7-2017.html
This article is part of the Asiannabis Community educational series on regulation and compliance. It gives general information about international rules. It is not legal advice and does not describe Thai law. Check current requirements with the relevant authority before you act.