Brazil's new regulatory framework: how to read RDCs 1.012, 1.013, 1.014 and 1.015 of 2026

What changed and why it matters

Between January and February 2026, the Agência Nacional de Vigilância Sanitária (ANVISA, Brazil's national health surveillance agency) published a set of four collegiate-board resolutions —RDCs 1.012, 1.013, 1.014 and 1.015 of 2026— that reorganize the framework applicable to medical cannabis products in Brazil. The package replaces the landmark RDC 327/2019, which for more than six years was the reference rule for the manufacturing, importation and commercialization of these products in the country.

The change is not merely cosmetic. RDC 327/2019 had been designed as a transitional and limited regime: it regulated the health authorization of products, but left central matters in gray areas, such as the cultivation and domestic production of inputs, scientific research with the plant, and the status of patient associations that for years operated under individual judicial authorizations. The new RDCs seek to close those gaps and move into an administrative rule what until now depended on case-by-case decisions.

For companies, healthcare providers and patient organizations that operate or are evaluating operating in Brazil, the joint reading of the four resolutions —and not of a single one— is what defines the new compliance perimeter.

The four RDCs: a division by subject matter

The distinctive feature of the 2026 regulatory package is that ANVISA chose to break out into several instruments what previously coexisted in a single resolution. According to specialized coverage by ConJur on the agency's decision-making process, the structure follows a logic of separation by subject matter:

• Domestic production. For the first time the local production chain is regulated explicitly, instead of referring supply almost exclusively to importation. At the regulatory level, this opens up the possibility of a market for domestically sourced inputs subject to health control.
• Scientific research. A specific framework is established for research with the plant and its derivatives, a matter that under RDC 327/2019 was scattered or subject to interpretation.
• Non-profit patient associations. The activity of organizations that, for years, supplied products to their members on the basis of individual judicial authorizations is recognized and regulated. The new framework seeks to give that activity a predictable administrative status.
• Medical cannabis products. RDC 1.015/2026 updates the health authorization regime for the products that RDC 327/2019 had introduced.

The Conselho Regional de Farmácia do Rio Grande do Sul (CRF-RS, the regional pharmacy council of Rio Grande do Sul) has noted, in its analysis aimed at pharmacy professionals, that the package incorporates the authorization of magistral compounding (manipulação magistral), that is, the individualized preparation of formulas in pharmacies under prescription. This is a sensitive point for professional practice, because it shifts part of product availability from an exclusively industrial model toward one that also contemplates controlled magistral preparation.

Effective dates: a calendar worth noting

The distinction between publication and entry into force is key to planning compliance. The resolutions were published between January and February 2026, but their enforceability is neither immediate nor uniform. In the case of RDC 1.015/2026, entry into force was set for May 4, 2026, which granted regulated actors an adjustment period.

Companies that were already operating under RDC 327/2019 must review the transitional provisions of each new RDC to determine the treatment of current authorizations, migration deadlines and the additional requirements that apply from the date of entry into force. Any specific effective date for RDCs 1.012, 1.013 and 1.014 that differs from the one indicated must be verified directly in the official text published by ANVISA. [VERIFICAR FUENTE]

The judicial origin: STJ's IAC 16

The 2026 package did not emerge in an administrative vacuum. Coverage by ConJur links the drafting of the new RDCs to ANVISA's compliance with what was decided by the Superior Tribunal de Justiça (STJ, Brazil's Superior Court of Justice) in the Incidente de Assunção de Competência (IAC, jurisdiction-assumption proceeding) number 16. That proceeding addressed the judicialization of access to medical cannabis —in particular the proliferation of individual authorizations for cultivation and supply through associations— and pushed the agency to produce an administrative framework that would give predictability to a matter that had been resolved court by court.

In other words, the 2026 RDCs can be read as the regulatory response to a judicial mandate: instead of continuing to depend on individual decisions, the rule is moved into a norm of general application. That genesis is relevant for interpreting the rule, because it helps explain why the regulation of patient associations occupies a central place in the package and not a marginal annex.

Decision-making process and therapeutic scope

Another element highlighted in specialized coverage is the nature of ANVISA's internal process. According to the tracking by ConJur, approval by the collegiate board (Dicol) is reported to have occurred by unanimous vote, which suggests an institutional consensus on the general direction of the reform, beyond the technical debate on specific points.

As for scope, sector organizations have pointed out that the new framework expands the universe of conditions covered. The Associação Brasileira da Indústria de Cannabis (ABICANN, Brazilian Cannabis Industry Association) has noted, among the points of the package, the inclusion of fibromyalgia and lupus within the conditions considered by the regulation. It should be stressed that the regulatory recognition of a condition does not constitute an assertion of therapeutic efficacy: it defines the administrative perimeter within which a product may be prescribed and dispensed, not a clinical judgment on outcomes. The evaluation of the appropriateness of any treatment is the responsibility of the treating healthcare professional.

RDC 660/2022 remains in force, but under review

A point that often causes confusion: the 2026 reform did not repeal RDC 660/2022, which regulates the exceptional importation of cannabis products for personal use by patients. That resolution remains in force, but it is undergoing a review process. For patients and providers operating under the individual importation regime, this means that the current rules continue to apply until ANVISA publishes a possible amendment. It is advisable to follow the progress of that review through the agency's official channels before making medium-term sourcing decisions.

How to approach the transition

The 2026 package represents the most relevant regulatory change in medical cannabis in Brazil since 2019. Reading it correctly requires treating the four RDCs as a system —production, research, associations and products— and not as isolated rules, as well as distinguishing precisely between publication and effective dates, and between what changed (RDC 327/2019) and what remains under review (RDC 660/2022).

CannaTech supports companies, providers and organizations evaluating operating under the new Brazilian framework with regulatory advisory services oriented to the interpretation of the applicable RDCs, the mapping of compliance obligations and the planning of adjustment deadlines. For a reading tailored to a specific case, we always recommend starting from the official text published by ANVISA and contrasting any figure or date with the primary source.

Sources

• Agência Nacional de Vigilância Sanitária (ANVISA)
• ConJur — Consultor Jurídico
• Conselho Regional de Farmácia do Rio Grande do Sul (CRF-RS)
• Associação Brasileira da Indústria de Cannabis (ABICANN)