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

Cannabinoid drugs, medicinal cannabis and opioid drugs in Malaysia – a comprehensive legal overview. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for USD 99.

CANNABINOID DRUGS

1. Are Cannabinoid Drugs authorized in your country?

The Malaysian regulatory authority does not authorise the use or sale of any specific drug per se, i.e. cannabinoid drugs, rather it regulates the registration of products which may include cannabinoid drugs as an active ingredient of such products. Products are registered on a case by case basis.

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

The primary authority with jurisdiction over Cannabinoid Drugs is the National Pharmaceutical Regulatory Agency (NPRA) established under the Ministry of Health (MOH) of Malaysia.

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

We are not aware of any such regulatory framework in Malaysia. The only relevant regulatory framework lies in the registration of a product which may include Cannabinoid Drugs as an ingredient, and this would be carried out in accordance with the general authorisation, pricing and reimbursement scheme for registration of any product, medicine or device.

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

Please see our comments in Question 1 above – there is therefore no Cannabinoid Drugs per se that has been approved to date.

5. Who can prescribe Cannabinoid Drugs?

We are not aware of anyone who can prescribed Cannabinoid Drugs. Upon registration of a product containing Cannabinoid Drugs however, any registered medical practitioner, registered dentist and registered veterinarian may prescribe the said product.

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

We are not aware of any list of doctors who are authorised to prescribe Cannabinoid Drugs. As long as a product containing Cannabinoid Drugs is registered, any doctor registered with the relevant council may prescribe the use of the said product.

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

We are not aware of any approval or notification required to prescribed Cannabinoid Drugs. The only approval we are aware of is from the NPRA for the registration of products containing Cannabinoids.

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

We are not aware of any organisations authorised to sell/distribute Cannabinoid Drugs. Upon registration of a product it may be prescribed by a registered medical practitioner, registered dentist or registered veterinaries who would be authorised to sell/distribute the product containing the Cannabinoid Drug or by a licenced pharmacist.

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

We are not aware of any list of retailers/distributors authorised to sell Cannabinoid Drugs in Malaysia.

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

We are not aware of any current proposal or reforms to the regulation of Cannabinoid Drugs. But we are made to understand that there are proposal and reforms to the status, legality and authorisation of Cannabis which may affect the status of Cannabinoid Drugs in the future. This is elaborated in Question 13 below.

11. When are they likely to come into force?

Not applicable.

MEDICINAL CANNABIS

12. Is Medicinal Cannabis authorized in the country?

The Malaysian regulatory authority does not authorise the use or sale of Cannabis in Malaysia. It recognises the strains of active ingredients in Cannabis which is used in products that are registered with the relevant authority. Such products are registered on a case by case basis. In addition, Cannabis is a drug controlled under the Dangerous Drug Act 1952 (“DDA 1952”) and in accordance with the provisions of that Act, the Minister charged with the responsibility for medical and health services (“the Health Minister”) may authorise the cultivation of Cannabis for medicinal purposes, however to date, no such authorisation has been granted.

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

The primary authority with jurisdiction over Cannabis is the NPRA as is with all substance deemed to be a Dangerous Drug.

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

Whilst there are statutory provisions which empowers the Health Minister to regulate the authorisation of Cannabis for medicinal purposes, there is to date no such regulatory framework in place. The only relevant regulatory framework lies in the registration of a product which may include Cannabis as an ingredient, and this would be carried out in accordance with the standard authorisation, pricing and reimbursement scheme for registration of any product, medicine or device.

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

The production (manufacturing) and importation of medicinal cannabis is regulated by the NPRA. No cannabis, even for medicinal purposes, may be imported or produced without authorisation from the Health Minister. The NPRA does not authorise or regulate the production or importation of Cannabis, even for medicinal purpose but rather it regulates the production and import of products, which may contain Cannabis as an ingredient. In any event, all such products must be registered with NPRA.

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

The production and/or cultivation of Cannabis for medical purposes can only be authorised by the Health Minister and we are not aware of any such authorisation that has been issued to any person(s). Where any person(s) intend to import a dangerous drug, such as Cannabis, into Malaysia, an import authorisation in the prescribed form (Form C of the DDA 1952) must be approved by the Health Minister who will then issue an import certificate according to the prescribed Form A set out in the Second Schedule of the DDA 1952 which must be forwarded by the intending importer to the person from whom the drug is to be obtained. If the importer to whom the import authorisation is issued intends to import the drug in more than one consignment, a separate approval of import certificate must be obtained for each consignment.

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

Cannabis cannot be marketed and distributed in Malaysia, even for medical purposes.

18. How can patients obtain Medicinal Cannabis?

Patients cannot obtain Medicinal Cannabis per se, only the products which may contain Cannabis as an ingredient. In the event that Health Minster approves of the importation of Cannabis in accordance with the procedure stated in Question 16 above, it can only be prescribed by licenced bodies or registered medical practitioners, registered dentists and registered veterinarians authorised by the Health Minister to make such prescriptions.

19. Who can prescribe Medicinal Cannabis?

We are not aware of anyone who can prescribe Medicinal Cannabis.

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

We are not aware of any list of doctors authorised to prescribe Medicinal Cannabis.

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

We are not aware of any approval or notification required to prescribe Medicinal Cannabis as this is not permitted in Malaysia. The only approval required, is from the NPRA for the registration of products which may contain Cannabis as an ingredient for medicinal purposes.

22. Where is Medicinal Cannabis available?

We are not aware of anywhere in Malaysia which Medicinal Cannabis is made available.

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

We are made to understand that the Malaysia Psychiatric Association has called on the government to set up a review committee, consisting of medical and legal professionals, academicians and researchers, and other stakeholders in the community to review the status of medical cannabis before deciding on the legalisation of Cannabis in Malaysia as a whole.

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

OPIOID DRUGS

25. Are Opioid Drugs authorized in your country?

Yes, opioids are controlled drugs under the Dangerous Drugs Act 1952 and are commonly used in Malaysia. The types of opioids used in particular are weak opioids i.e. dihydrocodeine, tramadol and tramadol combinations rather than strong opioids i.e. morphine, oxycodone, pethidine and fentanyl.

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

The primary regulating authority on the possession, importation and exportation of raw opium is the NPRA under the MOH. In addition, the Poisons Board is an advisory board which reviews the list of poisons including opioid and is called upon to advise the Minister of Health on matters relating to poisons. The NPRA has jurisdiction over the registration of any drug-related product including those with opioid constituents.

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

We are not aware of any regulatory framework for the authorisation of Opioid Drugs per se, rather all products constituting any traces of various types of Opioids as an active ingredient must go through the necessary registration with NPRA, without which it cannot be sold or used in Malaysia. We are also not aware of any regulatory framework for the pricing and reimbursement of Opioid Drugs.

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

We are not aware of any Opioid drugs that have received market approval to date. However, there have been products registered in Malaysia which include Opioid Drugs as an active ingredient such as tramadol, codeine, dihydrocodeine morphine, oxycodone, pethidine, fentanyl and methadone.

29. Who can prescribe Opioid Drugs?

Opioid drugs are considered psychotropic substances and are thus regulated by the Poisons (Psychotropic Substances) Regulation 1989. Under the said regulation only a specific class of persons is permitted to possess psychotropic substances, and only a registered medical practitioner, registered dentist Division I, a veterinary surgeon or a person acting in accordance with the direction of a registered medical practitioner, registered dentist Division I or a veterinary surgeon is permitted to prescribe these psychotropic substances, like products containing Opioid Drugs.

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

We are not aware of any list of doctors authorised to prescribe Opioid Drugs.

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

The main requirement for the prescription of psychotropic substances including Opioid Drugs as an active ingredient, is that the prescriber must be registered with the appropriate authorities, for medical practitioner with the Malaysian Medical Council, for dentists with the Malaysian Dental Council and for veterinarians with the Malaysian Veterinary Council.

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

The only person(s) permitted to dispense any psychotropic substance whether or not for medical, dental or animal treatment is a licensed pharmacist or a pharmacist in the public service.

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

We are not aware of any list of retailers/distributors authorised to sell Opioid Drugs in Malaysia.

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

We are not aware of any proposals for reform or significant change to the regulation of Opioid Drugs given that these drugs are not being regulated in their raw form. We are not aware of any plans to reform the registration of products containing Opioid Drugs as active ingredients.

35. When are they likely to come into force?

Not applicable.