Brazil’s regulator of health has approved regulations which begin to transform years of political and legal delay into an operational framework for hemp-derived CBD in the country.
Anvisa, the National Health Surveillance Agency has recently established rules to expand access to CBD medical products. They also begin to outline how closely supervised extraction and cultivation can take place in this country.
In the case of hemp, this decision represents a move away from a system that relies mainly on imported products to one where controlled domestic production could be supported.
Access Expands
The compounding pharmacy will now be able dispense CBD based products via individualized prescriptions. This opens up a whole new avenue for patients to access CBD-based products. It should also increase the demand for CBD extracts that are standardized and have been regulated.
Anvisa has also expanded the ways in which patients may use the products. They now include the application of the product to the skin, under the tongue and oral inhalation, as well as the forms that were already permitted. In a statement, the agency emphasized that CBD-based products for use outside of medical purposes are still illegal. The framework remains focused on healthcare and monitoring.
Growing controlled
This package includes cultivation standards and guidelines for patient and company associations. It is the first time that Brazil has published national regulations for large-scale production in Brazil for medical and scientific purposes.
Pharma and research companies are allowed to grow plants that contain THC up to 0.3% under strict security and authorization controls. The entire process, from the seed to the final product, will be traceable. Patients associations won’t receive the open cultivation rights but they may be included in future public calls as part of a “controlled testing” approach or limited “sandbox”.
Leandro Sfatle, president of Anvisa, said that the agency couldn’t ignore the important role played by patient associations in Brazil’s medical marijuana system. The president noted that the patient associations stepped in when the private and state markets failed to provide access, which was a boon for many patients. According to him, the new regulations are designed to give associations a better legal structure.
Impact of Industry
Business implications will be significant, but how they are implemented will determine the final outcome.
Brazil’s CBD medical market is growing rapidly, largely due to imports and a narrow set of legal paths. Local cultivation would reduce costs, decrease dependence on imports, and help Brazilian pharmaceutical grade CBD production.
However, the compliance demands described — monitored growing areas, 24-hour security, and strict oversight — could restrict participation to well-capitalized companies and a small number of approved associations.
Next developments hinge on the implementation. How quickly Anvisa releases operating criteria, what number of authorizations is granted and whether or not the Sandbox model moves beyond its pilot phase will determine how things progress.
The competition in the Brazilian medical CBD market has intensified, as companies cut prices to gain market share.
Still missing
Even with the hemp breakthrough, there are still major issues.
This framework does not cover the broad uses of industrial hemp, such as grain or fibers, nor do they include general consumer markets.
Brazil’s hemp industry is in its early stages and is limited by time. This suggests that Brazil is testing the regulatory framework rather than launching a fully-fledged hemp economy.
A second question that remains unanswered is whether Brazil eventually increases its THC limit above 0.3%.
Brazil’s agricultural agency Embrapa argues that a THC level of 1.0% is necessary to make CBD production economically feasible and competitive internationally.
Legal background
This decision comes after a period of uncertainty in regulatory matters, influenced by court interventions.
Brazil’s Superior Court of Justice, in 2024, ruled that varieties of cannabis with minimal THC should not have the same treatment as drugs-type marijuana under Brazil’s Drug Law. They ordered regulators establish a legal framework for medical cannabis production.
Anvisa postponed the hemp rulemaking process in 2025 even though it was under court deadlines. Companies and patient associations were left without a path to domestic production.
The court then extended the date again. It now expects the cultivation finalization framework to be completed by the end of this year.