Medical Cannabis: New ANVISA Resolutions Redefine the Brazilian Pharmaceutical Market

The new resolutions published in 2026 by the Brazilian Health Regulatory Agency (“ANVISA”) mark a turning point in the regulation of medical cannabis in Brazil. More than simply updating specific rules, the regulatory package redesigns the sector’s architecture by establishing stronger foundations for research, cultivation, production, and commercialization, while introducing modern risk-based regulatory instruments, such as the regulatory sandbox.

This creates a new framework with a direct impact on the entire pharmaceutical supply chain — from manufacturers and importers to compounding pharmacies.

The progressive and modular strategy adopted by ANVISA to regulate the matter provides an important competitive advantage for companies in the sector: in this case, time will be an ally to business strategies. Companies that know how to take advantage of this time — which is not extensive — to adapt their businesses, anticipate legal and health regulatory requirements, structure production processes and supply chains, and train their teams will have a head start.

This will allow them to capture relevant market shares and gain a competitive advantage.

Regulatory Background of Cannabis in Brazil

In 2015, ANVISA began authorizing, on a case-by-case basis, the importation of cannabidiol (“CBD”) products upon medical prescription and individual authorization — a specific solution that initially enabled access but left the country dependent on foreign products.

In 2019, ANVISA Resolution RDC No. 327/2019 established the first regulatory framework for medical cannabis, allowing its sale in pharmacies and the importation of products and inputs, while still not authorizing domestic cultivation. In 2022, ANVISA Resolution RDC No. 660/2022 expanded access by allowing individuals to directly import such products, while also highlighting regulatory asymmetries and limitations on the development of a local production chain.

The scenario changed decisively in 2024, but through the Judiciary: the Superior Court of Justice (“STJ”) ordered ANVISA to regulate cannabis cultivation exclusively for medicinal and pharmaceutical purposes, establishing a reference threshold of up to 0.3% THC.

This set of factors, combined with the increasing judicialization of the issue, led to a broader review of the regulatory framework, culminating in 2026 with the publication of a new regulatory package by ANVISA. The package seeks to replace ANVISA Resolution RDC No. 327/2019 and establishes an integrated system covering the entire chain, from cultivation to the final product.

The Brazilian market will now be redefined. For the first time, medical cultivation has been permitted in the country under strict rules and exclusively for legal entities, while different regimes have been created for research, medical production, and an experimental regulatory environment (sandbox) to test alternative production models.

In practice, Brazil is moving away from a model based on exceptions and individual imports and toward a regulated domestic market, with greater legal predictability, incentives for local production, and stronger foundations for investment, innovation, and expansion of the pharmaceutical supply chain.

ANVISA’s Institutional Response

At its 1st Ordinary Public Meeting of 2026, ANVISA approved a set of resolutions that redesigns the regulatory treatment of medical cannabis in Brazil. The strategy adopted is progressive and modular, combining rules of a more definitive nature with experimental instruments — such as the regulatory sandbox — allowing institutional learning without relinquishing health regulatory oversight.

Regulatory Plan Approved by the STJ

This new regulatory framework is part of the implementation of a regulatory plan approved by the First Section of the STJ in June 2025, in connection with Special Appeal No. 2,024,250 (Incident of Assumption of Competence No. 16/STJ). The plan, jointly submitted by the Federal Government and ANVISA, aims to structure the regulation of health-related aspects concerning the importation and cultivation of cannabis for medicinal purposes.

In this context, the measures adopted by the Agency — including the creation of the regulatory sandbox and the issuance of specific resolutions — implement the judicial decision in a technical and coordinated manner, in cooperation with other bodies of the Federal Public Administration, such as the Ministry of Agriculture and Livestock (“MAPA”), which is responsible for the phytosanitary requirements applicable to the importation of seeds.

ANVISA’s New Resolutions and Their Main Provisions

ANVISA Resolution RDC No. 1,015/2026 – Manufacturing, Importation and Commercialization

As the central pillar of the regulatory transition, ANVISA Resolution RDC No. 1,015/2026 enters into force on May 4, 2026, and repeals RDC No. 327/2019. The new regulation governs the manufacturing, importation, and commercialization of cannabis products for human medical use.

The main developments include:

• stronger regulatory requirements, bringing these products closer to the regulatory framework applicable to medicines;
• clearer requirements for health authorization and proof of safety and quality;
• provisions establishing deadlines for clinical research and the generation of scientific evidence;
• the incorporation of new routes of administration, including oral, buccal, sublingual, and dermatological routes, among others;
• expansion of the list of authorized prescribers to include dentists;
• recognition of the possibility of magistral compounding, subject to the issuance of specific regulations.

In practice, RDC No. 1,015 signals a transition from an exceptional model to a more structured regime focused on the development of the domestic market.

ANVISA Resolution RDC No. 1,012/2026 – Cultivation for Research

Effective as of August 4, 2026, ANVISA Resolution RDC No. 1,012/2026 establishes requirements for the cultivation of Cannabis sativa L. exclusively for scientific research. The activity will require a specific Special Authorization, reinforcing health regulatory controls and supply-chain traceability.

ANVISA Resolution RDC No. 1,013/2026 – Cultivation for Medicinal and Pharmaceutical Purposes (THC ≤ 0.3%)

Also entering into force in August 2026, ANVISA Resolution RDC No. 1,013/2026 governs the cultivation of the plant with a THC content equal to or below 0.3% for medicinal and pharmaceutical purposes. Companies interested in this production model will likewise be required to obtain Special Authorization, establishing a national regulated cultivation regime for therapeutic applications.

ANVISA Resolution RDC No. 1,014/2026 – Regulatory Sandbox

As a complementary instrument, ANVISA Resolution RDC No. 1,014/2026 establishes an Experimental Regulatory Environment (regulatory sandbox) for the controlled testing of activities related to medical cannabis.

The sandbox creates a temporary, supervised, and reversible environment for assessing health risks, generating regulatory evidence, and improving the regulatory framework — particularly for initiatives that do not yet fit within the traditional regulatory framework. This is risk-based regulation, not market liberalization.

Impact on the Market

The new regulatory framework has direct implications for pharmaceutical companies, importers, distributors, and potential domestic producers:

• strengthening of the domestic market and incentives for local production;
• greater regulatory predictability for medium- and long-term investments;
• a gradual movement toward equal treatment of domestic and imported products, although RDC No. 660/2022 remains in force for the time being.

For compounding pharmacies, the scenario is particularly relevant. ANVISA’s Collegiate Board removed the general prohibition on the magistral compounding of cannabis derivatives, indicating that the activity will be regulated by specific rules, with particular health requirements — potentially stricter than those currently provided for under RDC No. 67/2007. In practical terms, the sector can already begin preparing for this new regulatory framework.

What Comes Next

Despite the significant progress, the 2026 regulatory package does not conclude the regulatory agenda. The following matters remain pending:

• the specific regulation governing the magistral compounding of cannabis-based products;
• the definition of objective criteria for the use of trade names;
• the initiation of a specific regulatory proceeding to reassess RDC No. 660/2022 (importation by individuals), including a Regulatory Impact Analysis and public consultation.

These next steps will be decisive in consolidating the new market and ultimately defining the balance between access, innovation, and health regulatory oversight in Brazil.

This material is for informational purposes only and should not be used independently as a basis for decision-making. Specific legal advice may be provided by one of our attorneys. All copyrights are reserved by KESTENER VIEIRA TORRONTEGUY SPEGIORIN ADVOGADOS.