Brazil Cannabis Market 2026: Essential ANVISA Compliance Guide

Brazil has approved landmark cannabis regulations — what does it take to enter the market?

Brazil is the largest medical cannabis market in Latin America. The country’s cannabis industry generated nearly R$1 billion in 2025, serves over 672,000 registered patients, and is growing at more than 20% per year. In January 2026, the country’s health regulatory agency ANVISA unanimously approved four new resolutions that legalized cannabis cultivation, expanded patient access, and created a regulatory sandbox for controlled testing. For international cannabis companies, Brazil now represents one of the most significant market entry opportunities in the world.

Brazil’s naturally warm climate, massive population of 215 million, and established pharmaceutical distribution infrastructure make it an attractive destination for cannabis producers. However, the market is tightly regulated by ANVISA, and entering it requires understanding a complex web of licensing, compliance, and partnership requirements.

This guide covers what you need to know about the Brazil cannabis market: the regulatory framework, market data, licensing requirements, and compliance standards for companies looking to operate in the country.

Cannabis Legalization in Brazil

Medical cannabis in Brazil was first regulated in 2019 under RDC 327, which allowed the manufacturing, importing, and selling of cannabis-based products. Products had to be CBD-dominant with a maximum of 0.2% THC. Domestic cultivation was prohibited, meaning every cannabis product consumed in Brazil had to be imported from abroad.

ANVISA (Agencia Nacional de Vigilancia Sanitaria) is the primary regulatory body overseeing cannabis in Brazil. It approves products, issues manufacturing and import licenses, sets GMP standards, and manages the SNGPC national tracking system. Other key agencies include MAPA (Ministry of Agriculture) for hemp cultivation and Embrapa (Brazilian Agricultural Research Corporation), which launched a 12-year cannabis research program from 2025 to 2037.

In 2022, RDC 660 created the individual patient import pathway, enabling patients to obtain ANVISA authorization to import cannabis products for personal medical use. This channel now serves approximately 47% of Brazil’s cannabis patients and processes over 500 daily import requests.

June 2024: STF Decriminalization Ruling

In June 2024, Brazil’s Supreme Federal Court (STF) decriminalized personal cannabis possession of up to 40 grams and set a threshold of six plants for personal cultivation. While this did not legalize recreational use, it marked a significant shift in the country’s approach to cannabis policy and removed criminal penalties for small-quantity possession.

November 2024: STJ Cultivation Mandate

In November 2024, the Superior Court of Justice (STJ) validated commercial cannabis cultivation and ordered ANVISA to regulate within six months. This landmark ruling responded to years of patient advocacy and court mandates, and directly set the stage for the January 2026 regulatory overhaul.

ANVISA’s January 2026 Regulatory Breakthrough

On January 28, 2026, ANVISA’s Collegiate Board unanimously approved four new Resolutions of the Board of Directors (RDCs) that together create a comprehensive regulatory architecture:

1. Commercial exploitation of cannabis for medicinal and pharmaceutical purposes
2. Scientific research on cannabis, including clinical trials and agricultural research
3. Cultivation of Cannabis sativa L. with THC content of 0.3% or less
4. Regulatory sandbox for controlled testing of cultivation and extraction processes

These four RDCs replace the restrictive RDC 327/2019 framework. Key changes include:

• Cannabis cultivation is formally authorized for the first time under ANVISA regulation
• ANVISA will open public calls for non-profit patient associations to conduct controlled cultivation testing
• Compounding pharmacies can now dispense CBD-based products via individualized prescriptions
• Products with THC above 0.2% are now available for patients with serious and debilitating diseases, not only terminal cases
• New administration routes are authorized: inhalation, buccal, sublingual, and dermal delivery
• Dental surgeons are now authorized to prescribe cannabis products

The new framework becomes fully effective on August 4, 2026 — 180 days from publication in the Official Gazette. Meanwhile, the STJ has set a separate March 31, 2026 deadline for ANVISA to finalize cultivation-specific regulations. Organizations that begin building compliance infrastructure before August 2026 will have a significant first-mover advantage.

Medical Cannabis in Brazil

The numbers tell a compelling story. The Brazil cannabis market generated R$971 million in 2025, up 22% from R$853 million the prior year, approaching the symbolic R$1 billion milestone. More than 672,000 patients accessed cannabis-based therapies in 2024, a 56% increase year-over-year, with coverage reaching over 80% of Brazil’s municipalities. Analysts at Cognitive Market Research project a 24.6% compound annual growth rate (CAGR) through 2030. If regulatory expansion allows cannabis-based treatments for chronic pain — a category affecting an estimated 3.4 million Brazilians — the addressable market could reach R$4.7 billion.

Patient Access Channels

Patients currently access medical cannabis through three distinct channels:

Source: Kaya Mind via InternationalCBC

Over 2,180 cannabis-based products are available in the country, supplied by more than 500 companies exporting from the United States, Canada, Colombia, Uruguay, the Netherlands, and Spain.

Brazil’s Patient Association Model

One of the most distinctive features of the Brazil cannabis market is the patient association model. As of mid-2025, 259 associations were registered, with 40 holding judicial authorization to cultivate cannabis. Leading associations include ABRACE Esperanca (over 50,000 patients served), APEPI (Brazil’s largest legal cannabis farm at 42 hectares), and AMA+ME (3,300 patients).

Products sourced through associations cost R$79 to R$180 per bottle, compared to R$300 to R$1,000+ through pharmacies and R$480 to R$777 through imports — savings of 90% or more. At ABRACE Esperanca, 20% of patients receive their products free of charge, a level of access unmatched by any commercial channel.

Until January 2026, patient associations operated in a legal gray zone. Cultivation authorizations came through judicial orders secured case by case, and only 15.38% of cultivating associations had full judicial guarantees. The new ANVISA framework changes this fundamentally: associations now have a formal regulatory pathway through ANVISA’s public calls for controlled cultivation testing. The national federation FACT Brasil, representing over 50 associations and 30,000 patients, continues to advocate for inclusive regulation.

How to Enter the Brazil Cannabis Market

For international cannabis producers and manufacturers, the Brazil cannabis market presents a significant but carefully regulated opportunity. The most critical rule is this: you must partner with a Brazilian pharmaceutical company. Foreign entities cannot directly hold sanitary authorization without a local partner that maintains its own AFE and AE. Sanitary authorizations are valid for five years, with a proposed revision allowing one five-year extension.

License Types

Market Entry Requirements

• Product dossier and all labeling must be in Brazilian Portuguese
• GMP certification (WHO GMP or PIC/S) recognized by ANVISA
• Certificate of Analysis (COA) in Portuguese for all imported products
• Tamper-evident and child-resistant packaging is mandatory
• No trade names are permitted — products are designated by derivative name plus company name

International producers should also consider the regulatory sandbox as a lower-risk entry point for testing products and processes, and evaluate patient association partnerships for the new cultivation pathway. Engaging local legal counsel with cannabis expertise is essential — firms like Mattos Filho, Demarest, and Daniel Law have published detailed analyses of the new framework.

Compliance and Seed-to-Sale Requirements

For producers and manufacturers targeting the Brazil cannabis market, compliance is not optional — it is the price of entry. The January 2026 framework maintains and in some cases strengthens the rigorous standards that ANVISA has established. GMP compliance forms the backbone of Brazil cannabis regulation:

• CBPF (Good Manufacturing Practice Certificate) is mandatory for all manufacturers
• SNGPC (Sistema Nacional de Gerenciamento de Produtos Controlados) integration is mandatory — this national tracking system requires digital tracking from cultivation or importation through final dispensing
• Full batch traceability for production and distribution records must be maintained
• All packaging must include traceability codes and product identification
• ANVISA recognizes WHO GMP and PIC/S certification for internationally certified facilities

For patient associations transitioning from informal operations to regulated participants under the new framework, standardized batch records, testing documentation, and dispensation tracking are no longer optional — they are prerequisites for participating in ANVISA’s public calls.

If you are producing cannabis for the Brazilian market (or plan to), you will need a seed-to-sale platform that can meet ANVISA’s strict recordkeeping and traceability standards. GrowerIQ’s cannabis compliance platform provides the digital infrastructure that producers need — from cultivation analytics and batch record management to traceability reporting and multi-facility oversight. The platform supports Portuguese-language documentation, Certificates of Analysis, and regulatory reporting. For organizations preparing to enter the Brazil cannabis market, building compliance systems before the August 2026 effective date is a strategic advantage.

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GrowerIQ’s cannabis compliance platform helps producers meet ANVISA’s GMP, traceability, and batch documentation requirements. Let’s discuss your project and customize a plan for entering the Brazil cannabis market.