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

All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Colombia. Prepared in association with Cavelier Abogados, a leading law firm in Colombia, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 99.

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

Yes, cannabinoid drugs are authorized in Colombia. However, they are subject to government control and to a specific regulatory framework.

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

The following are the most relevant offices:

• Ministry of Health and Social Protection: Authority in charge of granting licences to manufacture cannabinoids and assign quotas for production.
• National Fund of Narcotics (FDE): Authority in charge of overseeing import, exports, distribution and sale of narcotics.
• Ministry of Justice and Law: Authority in charge of granting licences for seed usage and cannabis cultivation.
• INVIMA: Authority in charge of the registry for pharmaceutical products of human use amongst others.
• ICA: Authority in charge of the registry of seeds cultivators, plant breeders and seeds testing, registry of seeds variety and pharmaceutical registry, amongst others for animal purposes.

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

Yes, since 2016 there has been a regulatory framework that seeks to apply from breeding to the sale of Cannabinoid Drugs. However, there is no specific regulation for pricing and reimbursement of cannabinoid drugs.

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

The first cannabinoid drug to received government approval in Colombia is Sativex from GW Pharma Ltd., a chemically-synthesized drug. To the date there is no authorized Cannabinoid drug as phytotherapeutic product.

5. Who can prescribe Cannabinoid Drugs?

Cannabinoid Drugs can be prescribed by any healthcare professional legally authorized to practice medicine in the country.

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

No, there isn´t.

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

The cannabinoid drug must be authorized to be sold in the country through a sanitary registry/marketing authorization granted by INVIMA.

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

Any pharmacy or drug store registered at the National Fund of Narcotics.

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

Although there is no list of authorized distributors available to the public, the retailers/distributors must be registered before the National Fund of Narcotics and keep record of all sales of cannabinoid drugs.

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

Currently, there are no proposals for significant change to the existing regulation. However, as the regulatory framework dealing with cannabinoid drugs is relatively new, there are possibilities of regulation improvements by the competent authorities.

11. When are they likely to come into force?

N/A

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

In Colombia, access to cannabis is authorized only for medical and scientific purposes.

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

• Ministry of Health and Social Protection: Authority in charge of granting licences to manufacture cannabinoids and assign quotas for production.
• National Fund of Narcotics (FDE): Authority in charge of overseeing import, exports, distribution and sale of narcotics.
• Ministry of Justice and Law: Authority in charge of granting licences for seed usage and cannabis cultivation.
• INVIMA: Authority in charge of the registry for pharmaceutical products of human use amongst others.
• ICA: Authority in charge of the registry of seeds cultivators, plant breeders and seeds testing, registry of seeds variety and pharmaceutical registry, amongst others for animal purposes.

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

REGULATORY FRAMEWORK

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

Production is regulated by the Health Ministry in conjunction with the National Narcotics Fund. On the other hand, import is regulated by INVIMA through the sanitary registry/marketing authorization of the product and also by the National Narcotics Fund.

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

There are four types of license that can be requested depending on the use to be made of cannabis.

• License to manufacture cannabis derivatives.
• License to use seeds for sowing.
• License for the cultivation of psychoactive cannabis.
• License for the cultivation of non-psychoactive cannabis plants.

Regarding licenses for the manufacture of derivatives and cultivation of psychoactive cannabis, additionally, a quota must be requested from the Health Ministry and the Ministry of Justice. This quota refers to the maximum amount of psychoactive cannabis in dry weight that you are authorized to acquire or receive from a licensee.

To import Medicinal cannabis, the product must have the marketing authorization granted by INVIMA.

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

Being substances subject to government control, medicinal cannabis advertising is restricted to health professionals only. It cannot be promoted in mass media and the sale can only be under medical prescription. Depending on the nature of the product, chemical synthesis or phytoterapeutic medicine, the general advertising rules for each type of product will apply also.

18. How can patients obtain Medicinal Cannabis?

Medicinal cannabis can only be acquired by patients through medical prescription.

19. Who can prescribe Medicinal Cannabis?

Dully licensed health professionals can prescribe Medicinal Cannabis.

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

No, there isn´t.

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

Medicinal cannabis must be authorized to be sold in the country through a sanitary registry/marketing authorization granted by INVIMA.

22. Where is Medicinal Cannabis available?

Any pharmacy or drug store registered at the National Fund of Narcotics.

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

Although there is no list of authorized distributors available to the public, the retailers/distributors must be registered before the National Fund of Narcotics and keep record of all sales of Medicinal Cannabis.

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

Currently, there are no proposals for significant change to the existing regulation. However, as the regulatory framework dealing with cannabinoid drugs is relatively new, there are possibilities of regulation improvements by the competent authorities.

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Opioid drugs are authorized in the country; however, they are subject to specific regulation and government control.

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

• National Fund of Narcotics (FDE): Authority in charge of overseeing import, exports, distribution and sale of narcotics.
• INVIMA: Authority in charge of the registry for pharmaceutical products of human application amongst others.

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

There is no specific regulatory framework regarding pricing and reimbursement of opioid drugs, however every activity involving this type of drug must be registered and authorized by the National Narcotics Fund.

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

Nowadays there are several opioid drugs approved in Colombia. Each time the approval of an opioid drug is granted by the sanitarian state authority, it must be informed to the National Narcotics Fund. Some approved are morphine, methadone, hydromorphone HCI, phenobarbital, among others.

29. Who can prescribe Opioid Drugs?

Opioid Drugs can be prescribed by any doctor legally authorized to practice medicine in the country.

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

No, there isn´t.

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

The sanitarian registry or marketing authorization granted by INVIMA and the notification to the national Narcotics Fund.

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

The National Narcotics Fund controls the sale and distribution of opioid drugs, so it keeps a record of all those authorized for the distribution of these drugs. Additionally, it manages agreements with some authorized pharmacies to sell these drugs to the public when dealing with opioids subject to government control.

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

Some opioids, despite being under the control of the state authorities, can be sold by the pharmaceutical laboratories that manufacture them; however, if they are subject of state monopoly, they can only be sold by the Fondos Rotatorios de Estupefacientes or through agreements made by the National Narcotic Fund with pharmacies nationwide. These agreements can be consulted by patients in general.

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

Currently there are no proposals for significant reforms to the regulation applying to Opioids.

35. When are they likely to come into force?

There are no reforms in consideration.