RDC 1.013 Cannabis Cultivation Authorization Brazil: The Full Framework, AE Requirements, and 4 August 2026 Deadline

RDC 1.013/2026 is the resolution that legalises domestic medicinal cannabis cultivation in Brazil. Here is what it actually does, why ANVISA had to publish it, and how it fits with the other four resolutions in the framework.

RDC 1.013 cannabis cultivation authorization Brazil is the operative phrase for every cultivator preparing for 4 August 2026. The resolution was published in the Diário Oficial da União on 3 February 2026 (dated 30 January 2026) and authorises domestic cultivation of medicinal cannabis at THC at or below 0.3%. It is the cultivation cornerstone of a five-resolution package (RDC 1.011 through RDC 1.015) that finally ends Brazil’s import-only supply model. This guide breaks down RDC 1.013 in plain English: who needs the Autorização Especial (AE), what the resolution requires across its six chapters, how the 0.3% cap differs from the 0.2% scheduling threshold most operators trip over, and what happens at the 5 August 2027 judicial transition deadline.

What Is RDC 1.013 and Why Did Brazil’s STJ Force ANVISA to Publish It?

RDC 1.013/2026 is the Resolução da Diretoria Colegiada (Collegiate Board Resolution) that establishes, for the first time in Brazilian regulatory history, a clear legal pathway for the domestic cultivation of medicinal cannabis. It was signed by ANVISA Director-President Leandro Pinheiro Safatle on 30 January 2026, published in the Diário Oficial da União (DOU Nº 23) on 3 February 2026, and takes effect on 4 August 2026. The resolution covers 32 articles across six chapters and replaces the patchwork of judicial habeas-corpus orders and import-only supply chains that defined Brazilian cannabis up to that point.

The framework was not voluntary. Article 1 of RDC 1.013 explicitly states that the resolution is published “em cumprimento ao acórdão proferido pelo Superior Tribunal de Justiça no Recurso Especial nº 2024250/PR, representativo do Incidente de Assunção de Competência 16”. Translated: ANVISA published these rules to comply with a unanimous November 2024 ruling from Brazil’s Superior Tribunal de Justiça (STJ) that ordered the agency to regulate domestic medicinal cannabis production within a fixed deadline. The court-mandated nature of the framework matters for operators because it changes the political-risk profile. This is not a discretionary policy ANVISA can quietly walk back. The timelines built into the resolutions exist because the STJ said so.

For international LPs and Brazilian operators, that single fact reshapes the calculus. Before RDC 1.013, every gram of medicinal cannabis raw material sold in Brazil had to be imported under an AE for imported raw material (RDC 327/2019), or grown under a court-ordered habeas-corpus exception. Domestic commercial cultivation was simply not legal. RDC 1.013 changes that overnight, while keeping cultivation export prohibited under Article 9, a constraint that materially affects any business case built around a hub-and-export model.

The Five-RDC Framework: How RDC 1.013 Fits With 1.011, 1.012, 1.014, and 1.015

ANVISA published five resolutions on the same day (3 February 2026), each covering a distinct activity. Read together they form a complete cannabis framework, but each one has its own scope, its own effective date, and its own operator audience. RDC 1.013 cannabis cultivation authorization Brazil sits at the centre, but the other four resolutions are the regulatory plumbing that makes commercial cultivation viable.

RDC 1.011 has been in force since the day of publication. It does not require any new ANVISA authorisation by itself; it just shifts how cannabis sits inside the existing Portaria 344 controlled-substance schedule. RDC 1.015 came into force on 4 May 2026, giving manufacturers and prescribers three months of overlap before the cultivation rules join them. That sequencing matters: by the time a domestic harvest is ready for handoff in late 2026, the products framework that will absorb it is already running.

RDC 1.014 deserves a specific note because it is widely misdescribed in industry channels. RDC 1.014 is a regulatory sandbox, not a clinical research framework. Clinical and academic research cultivation sits under RDC 1.012. Sandbox status under 1.014 is designed for small-scale operators and association-driven activity (patient associations like APEPI, for example) that do not fit cleanly into the commercial AE channel under 1.013. Operators evaluating which resolution applies to them should start by classifying their model: commercial supply (1.013), research only (1.012), or small-scale or association (1.014). Cultivators do not pick one over another; the resolution maps to the activity, and the AE is granted accordingly.

Who Needs an AE Under RDC 1.013? Commercial Cultivators, Research Entities, Associations

Article 3 of RDC 1.013 is the operative AE clause: “Para realizar o cultivo destinado a fins medicinais e de pesquisa da espécie vegetal Cannabis sativa L. de que trata esta Resolução, cada estabelecimento deve obter a AE que contemple expressamente a atividade de cultivo.” Plain English: every establishment cultivating Cannabis sativa L. for medicinal or research purposes under this resolution must hold an Autorização Especial that expressly covers the cultivation activity. The “expressly” wording matters. An AE granted for a different activity (manufacturing, importing, transport) does not extend to cultivation. Cultivation must be on the AE in its own right.

Three operator classes need to read the AE rules carefully:

• Commercial cultivators producing for the Brazilian medicinal market: AE mandatory under RDC 1.013. Petition criteria delegated to RDC 16/2014 (the foundational AE/AFE resolution) plus six cultivation-specific documents in Article 4.
• Research entities cultivating for non-commercial scientific work: AE under RDC 1.012, which sits adjacent to 1.013. Research cultivation may exceed the 0.3% THC cap if the AE expressly authorises the higher concentration under Article 6 of RDC 1.013.
• Patient associations and small-scale operators: regulatory sandbox under RDC 1.014. Associations operating under existing judicial habeas-corpus orders also have a transition path under Article 28 of RDC 1.013 (covered below).

Article 4 of RDC 1.013 specifies the six additional documents the AE petitioner must submit alongside the standard RDC 16/2014 dossier:

• Georeferenced geographic coordinates of the cultivation area
• Photographic record and descriptive layout of the cultivation areas, with measurements and dimensions
• Yield estimate per hectare and per square metre, consistent with the medicinal or research use
• Documentation proving the origin and acquisition method of the propagation material
• Organisational chart (organograma) showing roles, responsibilities, and lines of authority across cultivation stages
• Control and monitoring plan, prepared according to ANVISA’s technical guidance published on its website

Note Article 4 § 2, which gives ANVISA and the local sanitary authority the discretion to require additional documents on top of these six, based on a risk assessment. Operators should treat the Article 4 list as the floor of the petition dossier, not the ceiling. A common-sense readiness check is to assume the petition will be back-and-forth before grant.

What Does RDC 1.013 Actually Require? A Plain-English Walkthrough of Chapter II to IV

The 32 articles of RDC 1.013 are organised into six chapters. Chapter I sets definitions. Chapter II (Articles 3 to 6) governs the AE itself. Chapter III (Articles 7 to 12) handles importation, acquisition, and supply. Chapter IV (Articles 13 to 21) is the compliance backbone: monitoring, control, and traceability. Chapter V (Articles 22 to 24) regulates transport. Chapter VI (Articles 25 to 32) covers final provisions including the judicial-transition window. The two chapters operators spend the most time inside are Chapter II and Chapter IV.

Chapter II, The AE Itself

Article 3 establishes the AE requirement (above). Article 4 specifies petition criteria. Article 5 grants AE holders authorisation to acquire, cultivate, research, import, store, distribute, and supply Cannabis sativa L. at THC at or below 0.3%, with distribution and supply for commercial purposes restricted exclusively to medicinal use. Article 6 carves out a separate pathway: cultivation above 0.3% THC for research only, gated by RDC 1.012. The AE term itself is governed by RDC 16/2014: one year from the DOU publication date of the initial grant, annually renewable. (The Portuguese-language PDF circulating in industry channels states five years, which is incorrect. The five-year term applies to product authorisations under RDC 327/2019 and RDC 1.015, not cultivation under RDC 1.013.)

Chapter III, Importation, Acquisition, Supply

Articles 7 and 12 restrict propagation material: only material that demonstrably produces Cannabis sativa L. at THC at or below 0.3% may be imported or acquired, and import or export must satisfy MAPA requirements with genetic-origin documentation. Article 8 limits who may receive cultivated material from an AE holder, naming AE holders for pharmaceutical-input manufacture, research laboratories, AEP holders for teaching institutions, and AE holders for medicine manufacture for research. Article 9 explicitly prohibits the export of Cannabis sativa L., including seeds. Brazil under RDC 1.013 is a domestic-supply jurisdiction, not an export-licence regime. Article 10 closes specific import-export modalities (baggage, simplified import declaration, express courier, postal) with a narrow research exception. Article 11 dispenses with ANVISA’s prior anuência for import-export.

Chapter IV, Monitoramento, Controle e Rastreabilidade

This is the compliance backbone. Article 13 requires all establishment activities to be documented completely, faithfully, and traceably, with records retained for the minimum period set by Portaria 344/1998. Article 14 mandates a genetic-origin record for each propagation-material acquisition. Article 15 is the lot-level traceability standard. The verbatim Portuguese text reads:

In English: the operator must implement a traceability procedure that ensures identification of the plant species at the cultivation site, allowing, at a minimum, identification by lot number of the cultivation stage, the start date of the respective stage, the variety, and the quantity of plants. Five required fields per lot, at every cultivation stage. Article 16 then mandates per-lot laboratory THC analysis, with the analytical method drawn from the Farmacopeia Brasileira or another ANVISA-recognised pharmacopoeia, performed either in-house under licence or by a Reblas (Rede Brasileira de Laboratórios Analíticos em Saúde) laboratory.

Articles 17 through 21 round out Chapter IV: environmental escape prevention (Art. 17), destruction of above-0.3% material with 48-hour ANVISA notification (Art. 18), quarterly and annual BSPO reports on psychoactive and controlled substances (Art. 19), and the Production Estimate that an establishment must file before any activity begins (Art. 21). Article 21 paragraph 3 adds a commercial-reality check: the production quantities must be backed by contracts or letters of intent to purchase, sell, or distribute. Vaporware yield estimates are not acceptable.

How Does the 0.3% Cultivation Cap Differ From the 0.2% Scheduling Threshold?

This is the single most frequent point of operator confusion in the entire RDC 1.013 framework, and the answer is simple once the two numbers are separated by purpose.

The 0.3% number is the cultivation cap. It comes from Article 1 of RDC 1.013, which restricts the resolution’s scope to Cannabis sativa L. with total THC at or below 0.3% (expressed as a percentage of dry weight on the inflorescence). Cross above 0.3% and the cultivation falls outside RDC 1.013 entirely. Research cultivation above 0.3% is governed by RDC 1.012. Anything else above 0.3% is still prohibited under Portaria 344/1998, as Article 27 of RDC 1.013 makes explicit. The 0.3% line is the production ceiling for the new commercial framework.

The 0.2% number is the scheduling cutoff, and it lives in a different resolution: RDC 1.011/2026. RDC 1.011 reclassifies cannabis under Portaria 344. Cannabis with total THC above 0.2% sits on List A3, the entorpecente list, dispensed against a yellow controlled-substance prescription. Cannabis at or below 0.2% sits on List B1, the psicotrópicos list, dispensed against a blue prescription. The 0.2% line is a controlled-substance classification line that determines what prescription form a pharmacist uses, not what a cultivator may legally grow.

Why does the gap between the two numbers matter for cultivators? Because everything grown under RDC 1.013 will be classified on List A3 (yellow receipt) if THC sits between 0.2% and 0.3%, and on List B1 (blue receipt) if it stays at or below 0.2%. Both are legal to cultivate. Both are legal to manufacture into products under RDC 1.015. But the receipting, dispensing, and patient-side documentation differ. Operators planning crop genetics in the 0.2-to-0.3 band need both compliance pathways modelled in their records, including a lab analysis pipeline under Article 16 that can route results to the correct downstream receipt before harvest one.

For a deeper analysis of the cross-threshold trap and how operators in the 0.2-to-0.3 band should design their genetics and records, see our deep-dive on Brazil cannabis THC limits: 0.3% cultivation vs 0.2% scheduling.

When Does RDC 1.013 Take Effect, and What Happens at the 2027 Judicial Transition?

RDC 1.013 takes effect on 4 August 2026 (Article 32). That is the date on which AEs for commercial cultivation can be granted, the date on which the resolution becomes binding, and the date on which the four-ministry oversight committee (ANVISA, Ministry of Justice, Ministry of Health, MAPA) begins coordinated inspections. Before that date, no AE for commercial cultivation under RDC 1.013 can be granted. Operators preparing for entry should treat the months between February and August 2026 as the dossier-assembly window: gather Article 4 documents, align MAPA propagation paperwork, draft the BSPO production estimate, and stage the petition for filing as soon as ANVISA opens the queue.

For operators already cultivating in Brazil under judicial authority (habeas corpus or salvo-conduto), Article 28 of RDC 1.013 establishes a separate deadline: 5 August 2027. The verbatim text reads:

Judicial cultivators (commercial growers operating under court protection, patient associations like APEPI cultivating for member supply) have 18 months from the publication of RDC 1.013 to file an AE petition, receive a grant, and bring their existing operation into compliance. After 5 August 2027, judicial authority alone is no longer sufficient regulatory cover. The transition is not optional, and the calendar is not paused by ongoing judicial proceedings.

Article 28 also includes a useful operational provision in its sole paragraph: the plant material produced by judicial cultivators during the transition window may be supplied exclusively for medicinal and research purposes, per the terms of the resolution. That preserves the supply continuity associations and judicial cultivators have built over the past decade, but only on the condition that the AE migration is completed by 5 August 2027.

For operators evaluating the transition specifically (documentation transfer, what carries forward from a habeas-corpus dossier, what the AE adds on top), see our walkthrough of the habeas-corpus to ANVISA AE migration. For the AE petition mechanics themselves, see our step-by-step AE application guide. The Article 15 traceability backbone is covered in detail in our Article 15 batch traceability deep-dive.

Frequently Asked Questions

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