Bairo GonzalezLeandro · Martinez

In the world · Cannabis · 3 February 2026

RDCs 1,013, 1,014 and 1,015: what Anvisa changed

In February 2026, Anvisa published Brazil's new medical cannabis rules: cultivation, associations, research and wider access. What changed and what didn't.

bairogonzalez.com team, drawing on Bairo's story · Published

On February 3, 2026, Brazil's Official Gazette (Diário Oficial da União) carried the Anvisa resolutions that redesign medical cannabis in the country. RDC 1,013 regulates cultivation by authorized companies, RDC 1,014 creates a controlled path for patient associations, RDC 1,012 deals with research and RDC 1,015 replaces the former RDC 327/2019, broadening who can use products with more THC and by which routes. Recreational use remains prohibited.

What happened

The rules were approved by Anvisa's collegiate board (Anvisa is Brazil's health regulator) at a public meeting on January 28, 2026, and published a week later. According to the agency itself, they respond to a ruling by the Superior Court of Justice (STJ), which in November 2024 recognized the legality of production for exclusively medicinal and pharmaceutical purposes.

The package, in summary:

  • RDC 1,013/2026 (production): cultivation of plants with up to 0.3% THC, only by legal entities with Special Authorization, prior sanitary inspection and mandatory traceability.
  • RDC 1,012/2026 (research): rules for teaching and research institutions. Research material with THC above 0.3% continues to come from authorized imports.
  • RDC 1,014/2026 (associations): a specific instrument, described by Anvisa and the press as an experimental regulatory environment, for non-profit associations, with monitoring, quality indicators and traceability through dispensing. The rule does not authorize commercial sale.
  • RDC 1,015/2026 (products): updates the 2019 framework. Patients with serious debilitating diseases, such as fibromyalgia and lupus, can now use products with THC above 0.2%, previously restricted to palliative care. Routes of use expand to dermatological, sublingual, buccal and inhaled.

Compounding in pharmacies was accepted in principle, but Anvisa decided it will have its own rule, still to be written. According to the agency, the production resolutions take effect six months after publication.

Why it matters

Until now, Brazil lived with a contradiction: patients could use it, but the plant could not be grown in the country to make the medicine. Almost everything came from abroad, paid for in dollars. The new rule opens the door to a domestic chain, with sanitary control from planting to pharmacy.

For patients, the most concrete change is in RDC 1,015: more conditions covered, more forms of use and more documentation required, such as the consent form. For researchers, RDC 1,012 provides a clear path. And for associations, which already serve hundreds of thousands of people, RDC 1,014 creates a specific sanitary framework.

What did not change also matters: there is no release for recreational use, no over-the-counter sale, and the product still depends on a prescription from a qualified professional.

In Bairo's view

For Bairo Leandro Gonzalez Martinez, this is the kind of news that separates serious debate from noise. In his reading, medical cannabis has always needed three things at once: access, research and serious information. The 2026 RDCs touch all three. They broaden access, open up domestic research and require traceability, which is the technical way of saying that information must be verifiable.

In his reading, good regulation is not the enemy of innovation. It is what allows innovation to reach those who need it without putting anyone at risk. For him, the question that remains after the Official Gazette is not whether something was released, but who will properly explain the change to patients and doctors. That is the space where he sees work to be done.

Where this meets the ecosystem

Xperienc Global Labs, founded by Bairo and registered in London as a biotechnology research and development company, has medical cannabis as a scientific field. The proposal is to bring together laboratories, teleconsultation with a clinical assistant validated by a professional and the Global Language translator, used for a second clinical opinion, not for a medical report. Brazil's new framework is the ground on which any activity in the country must stand.

The idea of tracing each lot from planting to dispensing speaks to another front of the ecosystem: the verifiable record proposed by BTZ Chain. Here it is a vision, not a service anyone has contracted.

The path of the science, with what is already known and what is still being studied, is in The plant and the science. This text helps you understand the rule; the one who guides your case is a health professional.

Sources

  • Anvisa, "Anvisa publica regras para produção de cannabis medicinal" (Anvisa publishes rules for medical cannabis production), 02/03/2026: gov.br/anvisa
  • Migalhas, "Anvisa autoriza cultivo e amplia uso medicinal da cannabis no Brasil" (Anvisa authorizes cultivation and expands medical use of cannabis in Brazil), Jan. 2026: migalhas.com.br
  • Brasil de Fato, on the associations and the experimental environment, 01/29/2026: brasildefato.com.br
  • Portal Afya, on prescribing under RDC 1,015, Feb. 2026: portal.afya.com.br

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