Anvisa discusses rules for cannabis production in the country this Wednesday.

By Paula Laboissière, reporter for Agência Brasil - The collegiate board of the National Health Surveillance Agency (Anvisa) meets this Wednesday (28) to discuss the definition of specific rules for the production of medicinal cannabis in Brazil.

At the meeting, scheduled for 9:30 am at the agency's headquarters in Brasília, the directors will discuss the review of... Resolution 327/2019which currently regulates access to cannabis-based products.

The definition of rules complies with a decision by the Superior Court of Justice (STJ) which, in November 2024, determined the regulation of cannabis cultivation, provided it is exclusively for medicinal and pharmacological purposes.

Proposals

Earlier this week, Anvisa presented three different draft resolutions that regulate the production of medicinal cannabis, scientific research with the plant, and the work of patient associations.

In a press conference, the agency's president, Leandro Safatle, highlighted that the demand for cannabis-based products has grown exponentially over the last decade in the country.

"In Brazil, the evolution of the use of these products has been mainly recorded through the increase in individual imports. Between 2015 and 2025, that is, in the last 10 years, there were more than 660 individual import authorizations."

"We also have, in Brazil, 49 products from 24 companies authorized by Anvisa, available in pharmacies. There are also approximately 500 court decisions authorizing cultivation by individuals or legal entities," he added.

Safatle also highlighted that currently, five Brazilian states have laws authorizing the cultivation of medicinal cannabis.

The proposed regulations restrict cannabis production to legal entities and require prior health inspection. Safety requirements include 24-hour camera monitoring and georeferencing of the plantations.

Furthermore, authorization will be limited to products with a THC content equal to or less than 0,3%.

These measures also pave the way for non-profit production by patient associations. The goal is to assess the feasibility of small-scale production, outside the industrial model, through a public call for proposals.

During the interview, Anvisa director Thiago Campos emphasized the technical rigor used in drafting the resolutions, as well as their alignment with the STJ's decision and guidelines from international bodies.

"The measures defined here meet the requirements of international control, the conditions of the United Nations and the International Narcotics Control Board, and are aligned with what was stated in the STJ (Superior Court of Justice) judicial decision."

The proposals will be analyzed by the board. If approved, the resolutions will take effect on the date of publication and will have an initial validity of six months.

Understand

In November 2024, the Superior Court of Justice (STJ) ruled that the Drug Law does not apply to cannabis strains with very low concentrations of tetrahydrocannabinol (THC), the plant's active ingredient that causes intoxicating effects.

At the time, the ministers granted authorization to a company that appealed to the Court to import cannabis seeds with low THC content and high cannabidiol content, a compound that does not have narcotic effects but provides medicinal benefits.

In order for the decision to be enforced, the court mandated the regulation of seed importation, cultivation, and the industrialization and commercialization of cannabis strains with low THC concentrations (less than 0,3%). 

Deadline extended

The six-month deadline for defining the rules expired in September 2025, but was extended in November of the same year, following a request from the Attorney General's Office (AGU).

Immediately after the extension, Anvisa reported that it had already begun the necessary actions to comply with the ruling, including collecting contributions from civil society and preparing the technical documents and the draft of the regulatory act.

"The work also includes planning the steps for sanitary monitoring and control after regulation," the agency highlighted.

Numbers

Anvisa estimates that more than 670 people in Brazil use cannabis-based products. According to Anvisa, access to this type of treatment occurs primarily through legal channels.

According to the agency, since 2022, the Ministry of Health has complied with approximately 820 decisions regarding the provision of this type of product.

"Although unregulated in the country, many associations have obtained authorization from the courts to produce cannabis exclusively for medicinal use," Anvisa highlighted.