Brazil’s ANVISA Publishes 5 New Cannabis Resolutions: What Regulators, Operators, and Investors Must Know

How will ANVISA’s 5 new cannabis resolutions reshape Brazil’s growing market?

Brazil’s ANVISA cannabis resolutions 2026 represent the most significant overhaul of the country’s medical cannabis regulatory landscape since RDC 327/2019. On February 3, 2026, the Agência Nacional de Vigilância Sanitária (ANVISA) published four Collegiate Board Resolutions — RDCs 1,012 through 1,015 — plus sweeping amendments to existing Marketing Authorization rules, collectively establishing a new national framework for cannabis cultivation, pharmaceutical manufacturing, research, and regulatory experimentation. For cannabis operators, investors, and compliance teams monitoring Brazil’s rapidly expanding market — which grew 22% in 2024 to R$853 million and now serves roughly 672,000 medical cannabis patients — understanding what each resolution requires is not optional. It is a prerequisite for doing business in the world’s largest emerging cannabis market. For operators already using cannabis compliance software, this framework provides a clear checklist of what your systems must support before August 4, 2026.

The 5 ANVISA Cannabis Resolutions Explained

Brazil’s new regulatory framework was triggered by a November 2024 ruling from the Superior Court of Justice (STJ), which explicitly assigned ANVISA the authority and legal obligation to regulate domestic cannabis cultivation. The agency moved decisively, publishing five resolutions at its first public collegiate board meeting of 2026. The framework addresses every phase of the cannabis supply chain — from seed to pharmacy shelf — and closes regulatory gaps that had forced operators to rely on individual court orders for years.

Each resolution operates independently but together they form a coherent national framework — one that addresses the full cannabis supply chain from cultivation through patient access. The official resolutions are published on ANVISA’s legislation portal and are freely accessible in Portuguese.

What ANVISA Cannabis Resolutions 2026 Mean for Cultivators

For domestic cultivators, RDC 1,012 and RDC 1,013 draw a sharp operational and legal line between research activity and medicinal production. Understanding which authorization pathway applies to your business model is the first compliance step.

Under RDC 1,012, cultivation for research purposes is restricted to legal entities that have been previously accredited by ANVISA. Accreditation is not automatic — operators must demonstrate compliance with stringent criteria covering authorization procedures, physical security measures, full traceability and control systems, storage conditions, transportation protocols, and disposal procedures for waste material. Critically, the material grown under RDC 1,012 cannot be commercialized under any circumstances. It exists solely to generate scientific evidence that may eventually inform future regulatory decisions.

RDC 1,013 is where domestic commercial cultivation becomes possible, but within tight parameters. Cannabis sativa L. with a THC concentration at or below 0.3% may be cultivated under a Special Authorization from ANVISA. Operators must implement full seed-to-sale traceability, conduct regular laboratory testing to verify THC compliance at every stage, and destroy any plants that test above the legal threshold. Export of cultivated material is expressly prohibited — all material must remain within Brazil’s domestic supply chain. For operators currently cultivating under court orders (liminares), ANVISA has set a compliance transition deadline of August 5, 2027, providing approximately one year from the effective date to migrate to the formal authorization framework.

Both resolutions share a non-negotiable requirement: comprehensive, real-time plant and batch tracking. This is not a paper-based obligation — ANVISA’s traceability standards demand documentation at every touchpoint from planting through storage and supply. Operators who build their compliance infrastructure on purpose-built cannabis management software will have a measurable advantage over those attempting to manage traceability through spreadsheets or manual records.

Manufacturing and Pharmaceutical Requirements Under the New Framework

RDC 1,015/2026 amends Brazil’s foundational cannabis product regulation — RDC 327/2019 — and introduces detailed, codified requirements for pharmaceutical companies and importers seeking sanitary authorization to bring cannabis-derived products to market. For international companies eyeing Brazil’s growing patient base, this is the most consequential resolution in the package.

The new rules establish clear conditions and procedures for five interconnected activities:

• Manufacturing Authorization: Domestic producers must meet Brazilian Good Manufacturing Practice (GMP) standards and obtain formal sanitary authorization from ANVISA before producing cannabis-derived pharmaceutical products for human use. This closes a significant grey area that previously allowed some operators to manufacture without explicit product-level authorization.
• Import Authorization: Foreign manufacturers importing cannabis-derived products into Brazil must demonstrate compliance with Brazilian pharmaceutical standards, including documented evidence of product quality, safety, and efficacy. ANVISA will assess each application against the updated standards established in RDC 1,015.
• Commercialization Standards: Retail pharmacies, distributors, and wholesalers face updated requirements for cannabis product storage, dispensing procedures, and record-keeping obligations. Compliance with these rules is a condition of continued market participation.
• Prescription Rules: The framework clarifies which licensed healthcare professionals may prescribe cannabis-derived products, under what clinical conditions, and with what documentation requirements — providing legal certainty for prescribers and reducing off-label exposure.
• Pharmacovigilance and Post-Market Monitoring: Post-market surveillance obligations are now explicitly mandated. Manufacturers and importers are responsible for adverse event reporting, product quality monitoring, and periodic safety reporting to ANVISA throughout the product lifecycle.

For compliance teams, RDC 1,015 creates a checklist of system requirements: batch records, GMP documentation, import dossiers, adverse event tracking, and distribution records must all be audit-ready. ELS Solutions has documented the full scope of this regulatory milestone for international operators evaluating market entry.

The Regulatory Sandbox: RDC 1,014 Explained

One of the most innovative elements of ANVISA’s 2026 framework is RDC 1,014, which establishes a formal Regulatory Sandbox for medicinal cannabis. This approach — borrowed from financial services regulation and applied for the first time to Brazilian cannabis law — allows carefully selected participants to test cultivation, plant raw material production, and preparation of cannabis derivatives on a small scale and outside an industrial operating model, all under direct ANVISA supervision.

The sandbox is explicitly experimental and temporary. Participation does not confer vested rights, does not constitute a definitive authorization, and does not guarantee future licensing. Instead, it is designed to generate real-world operational evidence that ANVISA can analyze and use to inform the next generation of cannabis regulations. For startups, research institutions, and early-stage operators that are not yet ready to commit to full industrial-scale compliance, the sandbox represents a legitimate, supervised pathway into Brazil’s regulated cannabis ecosystem.

Mattos Filho’s analysis of the new Brazilian framework notes that the sandbox mechanism signals ANVISA’s intent to use evidence-based regulation — adapting rules as real-world operational data emerges, rather than imposing fixed frameworks before the market fully matures.

Timeline and Implementation Deadlines

The six-month gap between publication (February 2026) and effectiveness (August 2026) is deliberate — ANVISA intends it as an implementation runway for operators to build or upgrade their compliance systems, documentation processes, and physical facilities. Treating this window as a waiting period rather than an active preparation phase is the single most common mistake operators make when a new regulatory framework publishes. With just months until enforcement begins, the time to act is now.

Key Takeaways

FAQ: ANVISA Cannabis Resolutions 2026

What are the ANVISA cannabis resolutions 2026 and when do they take effect?

The ANVISA cannabis resolutions 2026 refer to four Collegiate Board Resolutions — RDC 1,012, RDC 1,013, RDC 1,014, and RDC 1,015 — published on February 3, 2026, along with new Marketing Authorization rules. Together, they establish Brazil’s national framework for cannabis research cultivation, medicinal cultivation, pharmaceutical product authorization, and regulatory sandbox experimentation. All resolutions take full legal effect on August 4, 2026.

Can cannabis be legally cultivated in Brazil under the new rules?

Yes, under specific conditions. RDC 1,012 permits cultivation by ANVISA-accredited legal entities for research purposes only, with no commercialization of the resulting material. RDC 1,013 permits medicinal cultivation of Cannabis sativa L. with THC content at or below 0.3%, under a Special Authorization. Export of cultivated material is expressly prohibited under both resolutions. Operators currently cultivating under court orders must transition to the formal authorization framework by August 5, 2027.

What does the Regulatory Sandbox mean for new cannabis businesses in Brazil?

RDC 1,014’s Regulatory Sandbox allows startups, research institutions, and early-stage operators to test small-scale cannabis activities — including cultivation and derivative preparation — in a supervised, temporary environment under ANVISA oversight. Participation is approved by ANVISA, does not guarantee future licensing or vested rights, but provides a legitimate, evidence-generating pathway into Brazil’s regulated cannabis market. It is particularly relevant for operators that want to demonstrate operational and compliance capability before committing to full industrial-scale investment.

Ready for ANVISA Compliance?

GrowerIQ’s seed-to-sale platform supports ANVISA’s track-and-trace and reporting requirements out of the box — from plant-level traceability under RDC 1,013 to batch documentation for pharmaceutical manufacturers under RDC 1,015.

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