Legal & Regulatory > Thailand > Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

The low-down on the situation regarding cannabinoid drugs, medicinal cannabis and opioid drugs in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for USD 99.

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

For the purpose of this chapter, cannabinoid drugs are drugs containing a cannabinoid, which may be extracted and purified from a cannabis plant or synthesized by other means without involving a cannabis plant.

In Thailand, there is currently no legal distinction between cannabinoids from a cannabis plant and synthesized ones. Therefore, all types of cannabinoids fall under medical cannabis regulations per the Narcotics Act, as amended.

Cannabinoid drugs are authorized in Thailand under strict regulations. In fact, cannabis-related activities—including production, importation, exportation, distribution (inclusive of prescription), and possession—are now licensed for medical purposes only.

Generally, formulations of cannabinoid drugs must be approved under either the Drug Act or the Narcotics Act, depending on the THC level; while business operators (producers, distributors, etc.) must have a relevant license under the Narcotics Act to operate in connection with the cannabinoid drugs.

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

The Thai Food and Drug Administration (Thai FDA).

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

Authorization of cannabinoid drugs will follow the pathways of the Drug Act or the Narcotics Act, and any Ministerial Regulations or Notifications issued pursuant to such Acts.

Currently there is no specific pricing and reimbursement scheme for cannabinoid drugs.

4. Which are the cannabinoid drugs that have received market approval to date?

None.

5. Who can prescribe Cannabinoid Drugs?

Cannabinoid drugs must be prescribed by a Thai professional doctor, dentist, or pharmacist who is licensed by the Thai FDA to distribute medical cannabis.

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

There is currently no official list of doctors who are authorized to prescribe cannabinoid drugs.

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

Licenses for medical cannabis distribution, issued by the Thai FDA, are required. Please see question 5 (above) for details.

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

1. Hospitals, the Thai Government Pharmaceutical Organization, the Thai Red Cross, and other public entities having duties relating to public health, provided that they have a license for medical cannabis distribution issued by the Thai FDA, are authorized to sell and distribute cannabinoid drugs.
2. Other types of organizations that the Minister of Public Health may later prescribe in a Ministerial Regulation, provided that they have a license for medical cannabis distribution issued by the Thai FDA, will be authorized to sell and distribute cannabinoid drugs.

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

There is no official list of retailers or distributors authorized to sell cannabinoid drugs.

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

Notable proposals include: (i) removing medical cannabis (including cannabinoid drugs) from the scope of the Narcotics Act; and (ii) including medical cannabis (including cannabinoid drugs) in the National Health Security system.

11. When are they likely to come into force?

Currently unknown.

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

Medicinal cannabis is authorized in Thailand under strict regulations. In fact, cannabis-related activities—including production, importation, exportation, distribution (inclusive of prescription), and possession—are now licensed for medical purposes only.

Generally, formulations of medical cannabis drugs must be approved under the Narcotics Act, while business operators (producers, distributors, etc.) must have a relevant license under the Narcotics Act to operate in connection with the narcotics.

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

The Thai FDA.

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

Authorization of medical cannabis will follow the pathways of the Narcotics Act, and any Ministerial Regulations or Notifications issued pursuant to such Acts.

There is no regulatory framework in relation to pricing and reimbursement of medical cannabis.

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

There will be an exclusivity period until 2024, during which only Thai public entities (including public hospitals) may be licensed by the Narcotics Control Board for producing or importing medical cannabis. Private entities (including farmers and individual healthcare professionals) may have a standing for such license only if they operate jointly with such public entity.

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

Licenses for medical cannabis production or importation, issued by the Thai FDA, are necessary to produce or import medicinal cannabis. Please see question 15 (above) for details.

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

The previous chapter’s regulations on sale and distribution of cannabinoid drugs fully apply to medical cannabis:

Organizations authorized for sale/distribution:

1. Hospitals, the Thai Government Pharmaceutical Organization, the Thai Red Cross, and other public entities having duties relating to public health, provided that they have a license for medical cannabis distribution issued by the Thai FDA, are authorized to market and distribute medicinal cannabis.
2. Other types of organizations that the Minister of Public Health may later prescribe in a Ministerial Regulation, provided that they have a license for medical cannabis distribution issued by the Thai FDA, will be authorized to market and distribute medicinal cannabis.

For medical cannabis prescription, please see questions 19–21 (below).

18. How can patients obtain Medicinal Cannabis?

In addition to questions 19 and 22 (below), patients carrying medical cannabis for personal treatment under an authorized prescription are not required to have a Thai FDA license for possession. Patients can consult with their attending physicians whether medical cannabis should be used for treatment of diseases.

19. Who can prescribe Medicinal Cannabis?

Medical cannabis must be prescribed by a Thai professional doctor, dentist, or pharmacist who is licensed by the Thai FDA to distribute medical cannabis, provided that such prescription is for the purpose of medical treatment.

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

There is currently no official list of doctors who are authorized to prescribe medical cannabis.

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

Licenses for medical cannabis distribution, issued by the Thai FDA, are required to prescribe medicinal cannabis. Please see question 9.19 (above) for details.

22. Where is Medicinal Cannabis available?

According to the present regulations, medical cannabis must be prescribed by a Thai professional doctor, dentist, or pharmacist who is licensed by the Thai FDA to distribute medical cannabis.

Further, medical cannabis may be made available by hospitals, the Thai Government Pharmaceutical Organization, the Thai Red Cross, and other public entities having duties relating to public health, provided that they have a license for medical cannabis distribution issued by the Thai FDA.

Additionally, international transportation service providers may make medical cannabis available for emergency treatment, provided that such entity is licensed by the Thai FDA for possessing medical cannabis for such purpose.

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

There is no official list of retailers/distributors authorized to sell medical cannabis.

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

Notable proposals include: (i) removing medical cannabis from the scope of the Narcotics Act; and (ii) including medical cannabis in the National Health Security system.

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

For the purposes of this chapter, opioid drugs are drugs containing an opium derivative that are formulated for medical use (e.g., morphine and pethidine). Activities relating to this class of drugs—including production, importation, exportation, distribution (inclusive of prescription), and possession—are allowed for medical use under the Narcotics Act’s strict regulation.

Generally, formulations of medical opioid drugs must be approved under the Drug Act, while business operators (producers, distributors, etc.) must have a relevant license under the Narcotics Act to operate in connection with the narcotics.

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

The Thai FDA.

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

Authorization of opioid drugs will follow the pathways of the Drug Act and the Narcotics Act, and any Ministerial Regulations or Notifications issued pursuant to such Acts.

Pricing of certain opioid drugs (e.g., morphine) is controlled by the Narcotics Control Division of the Thai FDA. Reimbursement for some opioid drugs is permissible for patients under the National Health Security System.

28. Which are the Opioid drugs that have received market approval to date?

A number of opioid drugs have received market approval in Thailand, such as morphine, fentanyl, codeine, and pethidine.

29. Who can prescribe Opioid Drugs?

Opioid drugs must be prescribed by a Thai professional doctor, dentist, or pharmacist who is licensed by the Thai FDA to distribute opioid drugs.

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

There is currently no official list of doctors who are authorized to prescribe opioid drugs.

31. What approvals or notifications are required to prescribe Opioid Drugs?

Licenses for opioid drug distribution, issued by the Thai FDA, are required to prescribe opioid drugs. Please see question 29 (above) for details.

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

Hospitals, the Thai Government Pharmaceutical Organization, the Thai Red Cross, or other public entities, provided that they have a license for opioid drug distribution issued by the Thai FDA, are authorized to sell and distribute opioid drugs.

33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?

There is no official list of retailers or distributors authorized to sell opioid drugs.

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

There is no such proposal.

35. When are they likely to come into force?

Not applicable.