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

All about cannabinoid drugs, medicinal cannabis and opioid drugs in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

The National Health Surveillance Agency (“ANVISA”) recently approved (on December 11, 2019) the Resolution RDC No. 327/19 defining the procedure for granting the Sanitary Authorization for manufacturing and importing Cannabis Products (given name for industrialized products that contain plant derivatives or Cannabis Sativa active agents, with a medicinal purpose). Such rule also establishes requirements for its commercialization, prescription, dispensation, monitoring and supervision.

The aforementioned Resolution provides that the commercialization must occur upon medical prescription and exclusively in pharmacies without manipulation. Furthermore, the rule determines that Cannabis Products must have predominantly Cannabinoid (CBD), and must observe a limit of 0.2% tetrahydrocannabinol (THC), except in cases of palliative care exclusively for patients without other therapeutic alternatives, and in irreversible or terminal clinical situations.

Nonetheless, in order to manufacture and commercialize Cannabis Products in national territory, the interested company shall import the pharmaceutical input into the forms of vegetable derivative, phytopharmaceutical, in bulk, or industrialized product, once planting is still forbidden in Brazil.

Before such rule, only the importation of Cannabis’ based products was possible (through individuals for personal use or by companies interested in registering the product before ANVISA). The manufacturing of the product locally was ruled.

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

The regulatory authority with jurisdiction over Cannabinoid Products is ANVISA.

Federal Police, Civil Police and Army also have jurisdiction over Cannabinoids, considering that it is a controlled substance.

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

The main regulation on these subjects is the aforementioned Resolution RDC No. 327/19, which provides the procedure for granting the Sanitary Authorization (which allows the manufacture and importation of the Cannabis Products), and its commercialization under the terms of the Resolution.

Also, Ordinance No. 344/1998, which determines the substances and drugs subject to special control and Resolution RDC No. 17/2015, which authorizes the importation and determines the procedure for importation by individuals of Cannabis based products.

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

Resolution 327/2019 was published on December 11, 2019, thus there is no Cannabis Product approved based in this Resolution.

However, there is a product that received ANVISA’s marketing authorization few years ago based on the general rule for registration of synthetic drugs, the cannabis-based product called Mevatyl (also called Sativex in other countries).

5. Who can prescribe Cannabinoid Drugs?

According to Resolution No. 327/19, prescription is restricted to medical professionals duly registered before the Federal Medical Council, only when there is no other therapeutic option available in the Brazilian market.

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

No.

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

As mentioned above, the medical professionals must be duly registered before Federal Medical Council.

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

According to Resolution No. 327/19 the commercialization of Cannabis Products must occur exclusively by pharmacies without manipulation, upon presentation of prescription by a medical professional, legally qualified. Such pharmacies must be previously licensed before ANVISA and before local health authorities.

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

No.

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

The Resolution No. 327/19 was recently approved by ANVISA and will be reviewed after three years of its publication.

11. When are they likely to come into force?

The Resolution No. 327/19 will come into force 90 (ninety) days from the date of its publication (i.e. March 11, 2020).

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

According to Federal Law No. 11.343/2006, which established the Brazilian ‘National System for Public Policies on Drugs’ (SISNAD), it is forbidden in all national territory planting, growing, harvesting and exploiting vegetables and substrates from which drugs may be extracted or produced. Besides, Cannabis sativa L. is currently considered a proscribed substance by ANVISA on its Ordinance No. 344/1998 and, therefore, Medicinal Cannabis is still forbidden in Brazil.

Its legal use is restricted to the manufacturing and commercializing of Cannabis Products by legally registered companies. These companies, in order to fabricate the drugs, have to import the pharmaceutical input into the forms of vegetable derivative, phytopharmaceutical, in bulk, or industrialized product.

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

The regulatory authority with jurisdiction over Medicinal Cannabis is ANVISA, which still has not regulated the matter.

Federal Police, Civil Police and Army also have jurisdiction over Medicinal Cannabis, once it is a forbidden substance in Brazil.

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

As mentioned above, Medicinal Cannabis is still forbidden in Brazil and so there is no regulatory framework about its authorization, pricing and reimbursement yet.

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

The procedure for manufacturing and importing Cannabis Products is set forth in Resolution RDC No. 327/19. However, as mentioned above, since Medicinal Cannabis is still forbidden in Brazil, in order to manufacture and commercialize Cannabis Products in national territory, the interested company shall import the pharmaceutical input into the forms of vegetable derivative, phytopharmaceutical, in bulk, or industrialized product.

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

Companies cannot import or produce Medicinal Cannabis in Brazil.

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

There is no regulatory framework for the marketing and distribution of Medicinal Cannabis.

18. How can patients obtain Medicinal Cannabis?

Patients cannot obtain Medicinal Cannabis. However, according to Resolution No. 327/19, they must have prescription to obtain Cannabis Products, which is restricted to medical professionals legally registered before the Federal Medical Council.

Note that Cannabis Products may only be prescribed when there is no other therapeutic option available in the Brazilian market.

19. Who can prescribe Medicinal Cannabis?

The prescription of Medical Cannabis is forbidden. However, as mentioned in the previous question, Cannabis Products must be prescribed by medical professionals duly registered before the Federal Medical Council.

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

N/A

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

The prescription of Medical Cannabis is forbidden.

22. Where is Medicinal Cannabis available?

The prescription of Medical Cannabis is forbidden.

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

N/A.

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

No. At this moment, there are no proposals for reforming or significantly changing to the regulation of Medicinal Cannabis.

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Yes, Opioid Drugs are authorized since duly registered before ANVISA. Note that opioid substances are subject to special control (Ordinance No. 344/1998).

There are some opioid derivate substances that are forbidden in Brazil (List F1), for example, heroin.

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

The regulatory authority with jurisdiction over Opioid Drugs is ANVISA.

Federal Police, Civil Police and Army may also have jurisdiction over Opioid Drugs depending on the substance used on the drug, since it may be a controlled substance.

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

No, there is no specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs.

The only resolution that may be used as parameter is Ordinance No. 344/1998, which provides for substances subject to special control.

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

There are several drugs approved, on all of the four major categories: codeins, fentanyls, oxycodones and tramadols.

29. Who can prescribe Opioid Drugs?

The physician duly enrolled before the Medical Council.

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

No.

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

The physician must be duly registered before the Regional Medical Council.

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

In order to commercialize Opioid Drugs the interested company must be licensed before ANVISA and local health authorities, and the product must be duly registered before the Agency.

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

No.

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

We are not aware about any change in the regulatory framework.

35. When are they likely to come into force?

N/A