The information provided in this article is for general informational purposes only. While we endeavour to provide accurate and up-to-date information, there may be instances where information is outdated or incorrect. The contents of this article should not be taken as legal advice nor should it be relied upon in making any business, legal or other decisions. We encourage readers to consult with a qualified legal or professional advisor to obtain proper advice based on your unique circumstances. Cannavigia disclaims any liability for any loss or damage arising out of or in any manner connected with the use of or reliance on the information provided in this article. Note that Cannabis regulations in Brazil are evolving rapidly; always consult the Agência Nacional de Vigilância Sanitária (ANVISA) for updates.
Cannabis in Brazil is strictly regulated, and its legal status varies depending on the purpose of use. Recreational cannabis is illegal in Brazil, but since June 2024, possession of small amounts (up to 40 grams or six female plants) for personal use has been decriminalized and now carries only administrative penalties such as warnings, community service, or mandatory participation in educational programs.
Medical cannabis, however, is permitted under strict regulatory conditions. Patients may access cannabis-based products with a doctor’s prescription and authorization from the Agência Nacional de Vigilância Sanitária (ANVISA). In 2015, ANVISA removed cannabidiol (CBD) from the list of prohibited substances and allowed patients to import cannabis-based products with medical approval. The regulatory framework expanded further in December 2019, when ANVISA introduced Resolution RDC 327/2019, establishing rules for the manufacture, importation, prescription, and sale of cannabis-based medicinal products in Brazil.
Today, ANVISA oversees all aspects of medical cannabis authorization, product registration, importation, manufacturing, and distribution in the country. Companies and research institutions that wish to operate in the sector must comply with strict regulatory requirements. Universities and pharmaceutical companies may conduct clinical studies involving cannabis, but only after obtaining the necessary permits and approvals from ANVISA.
Importing or exporting cannabis products is also tightly controlled. Patients and companies must obtain special authorization from ANVISA before importing cannabis or its derivatives for medical use. These authorizations typically require medical documentation, product information, and regulatory approval. Failure to comply with these procedures can result in significant legal and administrative consequences.
As Brazil’s medical cannabis sector continues to evolve, so too does the complexity of its regulatory framework. In this comprehensive guide, we simplify the process of understanding cannabis compliance in Brazil by outlining the regulatory background, applicable fees, and the key steps required to operate within the legal framework. We also provide a clear roadmap to help businesses and stakeholders navigate Brazil’s evolving cannabis regulations, from initial authorization to ongoing compliance obligations, drawing on publicly available information from Brazilian regulatory authorities whose transparency has helped shape the responsible development of the country’s medical cannabis industry.
Cannabis history in Brazil dates back to the early colonial period. Although the plant is not native to the country, most researchers believe Cannabis sativa was introduced soon after Brazil’s discovery in 1500, when Portuguese explorers and enslaved Africans arrived in the region. Historical records suggest that cannabis seeds were brought by enslaved Africans, particularly from Angola, where the plant was already known and used. Over time, cannabis use spread among enslaved populations and later among indigenous communities and poorer segments of society.
During the eighteenth century, the Portuguese Crown actively encouraged the cultivation of cannabis—primarily hemp—for fiber production. A research paper by Carlini (2006) reported how official documents from the Portuguese administration instructed regional authorities, including the Governor of the Captaincy of São Paulo, to promote hemp cultivation because of its importance for producing ropes, textiles, and other naval materials essential to maritime trade.
By the nineteenth century, cannabis had begun to gain attention in medical circles. Influenced by research conducted by British physicians in India and by the popularity of cannabis among French intellectuals, Brazilian doctors began exploring the plant’s therapeutic potential. Cannabis extracts and preparations were recommended for several conditions, including insomnia, digestive disorders, nervous agitation, and respiratory illnesses. Cannabis cigarettes imported from France, known as Grimault Cigarettes were even marketed as treatments for asthma and other respiratory conditions.
Despite its early medical use, the perception of cannabis began to shift in the early twentieth century. The movement toward cannabis prohibition in Brazil intensified during the 1920s, particularly after the country participated in the Second International Opium Conference in Geneva in 1924. At this conference, the Brazilian delegate, Dr. Pernambuco Filho, played a pivotal role in advocating for the inclusion of marijuana alongside opium and cocaine on the list of controlled substances. Although cannabis was not originally on the conference agenda, Dr. Pernambuco strongly supported the Egyptian delegation’s proposal, arguing that marijuana was “as dangerous as opium.” His speech helped rally international support, ultimately leading to the approval of the measure and marking a significant step toward the global and domestic criminalization of cannabis. This international pressure contributed to the growing stigmatization of cannabis within Brazil.
Government repression of cannabis became more pronounced in the 1930s, culminating in Decree-Law No. 891 of 1938, which officially prohibited the cultivation and use of marijuana nationwide. Under this legislation, cannabis production became illegal and individuals caught using or possessing the drug could face criminal penalties. Brazil’s prohibitionist stance was later reinforced by the 1961 United Nations Single Convention on Narcotic Drugs, which classified cannabis as a controlled substance under international law.
Throughout the late twentieth century, Brazil maintained strict anti-drug policies. Under Law 6.368 of 1976, individuals found using or possessing drugs could face imprisonment. However, growing debates around public health and drug policy eventually led to reforms aimed at reducing criminal penalties for personal drug use. These debates laid the groundwork for later legislative changes and court decisions that would reshape Brazil’s approach to cannabis regulation.
Despite prohibition, medical research into cannabis continued globally, particularly into Δ9-tetrahydrocannabinol (Δ9-THC), which demonstrated therapeutic benefits such as anti-nausea effects, appetite stimulation, and usefulness for chemotherapy patients. In Brazil, public health debates gradually emerged, highlighting the limitations of criminal penalties for personal drug use and advocating for a more health-focused approach. Surveys published in 2005 estimated that roughly 6.9% of Brazilians between 12 to 65 years had used cannabis at least once, confirming the prevalence of use despite its illegality.
The first significant step toward legal medical cannabis came in 2015, when ANVISA removed CBD from the list of prohibited substances, allowing patients to legally import cannabis-based medicines with a doctor’s prescription.
In January 2017, Brazil reached a major regulatory milestone by granting its first authorization for a cannabis-based medicine, approving the commercialization of Mevatyl (internationally marketed as Sativex). This decision marked the formal entry of cannabis-derived pharmaceuticals into the Brazilian healthcare system and signaled a shift toward controlled medical use under regulatory supervision.
In 2019, ANVISA issued RDC 327/2019, establishing formal rules for the manufacture, import, prescription, and sale of medical cannabis products in Brazil.
Further progress followed in March 2020, when the State of Pernambuco issued a landmark judicial authorization permitting the home cultivation of cannabis for medicinal purposes. This license, granted to a patient for personal therapeutic use, set an important legal precedent and reflected the growing role of the judiciary in expanding access to cannabis-based treatments in Brazil. The framework was refined in 2022 with RDC 660/2022, which streamlined the exceptional import process and improved patient access to medicinal cannabis.
Most recently, in June 2024, the Supreme Federal Court (STF) ruled on the constitutionality of Article 28 of the 2006 Drug Law, decriminalizing the possession of small amounts of cannabis for personal use. The ruling clarified the distinction between personal use and trafficking, maintained the illegality of public consumption, and signaled Brazil’s gradual shift toward a more nuanced, health-focused approach to cannabis regulation.
Post-2024 developments accelerated Brazil’s regulatory modernization. On February 3, 2026, ANVISA published four new Rules of its Board of Directors (RDCs #1,012–1,015/2026), which collectively established the regulatory framework for medical, research, and commercial cannabis activities:
Recreational cannabis use remains illegal in Brazil, and the sale, distribution, or trafficking of cannabis continues to be punishable by criminal law. However, the legal treatment of personal possession changed following the supreme court’s order in June 2024.
Under the Court’s decision, individuals may possess up to 40 grams of cannabis or cultivate up to six marijuana plants at home without the risk of arrest or incarceration. This ruling reaffirmed and clarified earlier interpretations of Brazil’s 2006 Drug Law, which had already moved toward depenalizing personal use. While cannabis possession remains technically illegal, individuals found within these thresholds are not subject to criminal prosecution. Instead, authorities may impose administrative penalties, such as warnings, community service, or participation in educational programs related to drug use.
Medical cannabis is legal in Brazil but operates under a highly regulated framework designed to ensure patient safety, product quality, and strict oversight. Patients seeking access to cannabis-based treatments must first obtain a prescription from a licensed physician, who determines whether cannabis therapy is appropriate based on the patient’s medical condition. Once prescribed, patients must receive authorization from ANVISA.
Unlike many medical cannabis programs around the world, Brazil does not maintain a fixed list of qualifying conditions. Instead, treatment eligibility is determined case by case by the prescribing physician, based on clinical judgment and whether conventional treatments have proven ineffective or unsuitable for the patient. As a result, cannabis-based therapies are commonly prescribed for conditions such as treatment-resistant epilepsy, chronic pain, multiple sclerosis symptoms, Parkinson’s disease symptoms, autism spectrum disorders, anxiety disorders, sleep disturbances, and cancer-related symptoms, including nausea and loss of appetite associated with chemotherapy.
Brazilian regulations also differentiate between CBD-dominant products and products containing higher levels of THC. Products containing more than 0.2% THC are subject to stricter controls and are generally prescribed only for patients with severe or debilitating medical conditions, particularly when other treatment options have failed.
For many patients, access to medical cannabis has historically relied on imported products, authorized through ANVISA’s exceptional import framework. This system allows individuals with a valid prescription to import cannabis-based medicines for personal use, provided the products meet regulatory requirements and are approved by the agency. Over time, Brazil has gradually expanded its regulatory framework to support domestic distribution while maintaining strict quality controls.
A major milestone occurred in 2026, when ANVISA introduced RDC 1,015/2026, replacing the earlier RDC 327/2019 regulation that had governed cannabis-based products since 2019.
Key provisions of RDC 1,015/2026 include:
All cannabis-based products must obtain a Marketing Authorization from ANVISA before being manufactured, imported, or distributed in Brazil. This authorization requires companies to submit detailed technical and scientific documentation, including product composition, safety data, manufacturing processes, and quality-control specifications and this is where cannavigia’s modules come in handy.
Companies producing cannabis-based medicines must comply with pharmaceutical-grade manufacturing standards and obtain GMP certification. This requirement ensures that products are produced consistently and meet strict quality and safety standards comparable to other regulated medicines.
The regulation broadened the permitted forms of administration. Cannabis-based medicines may now be prescribed for oral, buccal, sublingual, and dermatological use, allowing physicians greater flexibility in tailoring treatments to patient needs.
Companies must maintain ongoing pharmacovigilance systems, including risk management plans and periodic benefit–risk assessments. These monitoring mechanisms allow ANVISA to track product safety after commercialization and implement corrective measures or recalls when necessary.
The use of trade names for cannabis-based products may be permitted under specific regulatory conditions. However, direct advertising or promotional marketing to patients remains prohibited, ensuring that medical cannabis products are prescribed based on clinical need rather than commercial promotion.
As of February 2026, nearly 50 cannabis-based products have been authorized for sale in Brazilian pharmacies under ANVISA’s regulatory framework. Most of these products are CBD-dominant oils or extracts approved under a simplified “cannabis-based product” regulatory pathway rather than the full pharmaceutical drug registration process.
Brazil has introduced distinct regulations for cultivation, depending on the THC content and purpose:
Governed by RDC 1,013/2026, effective August 4, 2026. Only authorized establishments may cultivate cannabis for medical or research purposes. Requirements include georeferencing of the cultivation area, proof of propagation material origin, traceability, and strict security and monitoring plans. Commercial distribution is allowed only for medical purposes.
Governed by RDC 1,012/2026, also effective August 4, 2026. Cultivation is restricted to universities, public research institutions, pharmaceutical companies, or state agencies. Research activities may include planting, harvesting, processing, and product development but are strictly non-commercial.
Importing and exporting cannabis or cannabis-derived products is tightly controlled:
Brazil maintains a strict regulatory framework for cannabis-related activities, with licenses primarily issued for medical, pharmaceutical, and research purposes.
Below are the key licenses and permits currently used in Brazil’s cannabis regulatory system:
This permit authorizes a company to legally operate within Brazil’s regulated pharmaceutical sector. It is required for businesses involved in the production, storage, distribution, or commercialization of cannabis-based products. The AFE serves as the foundational authorization before companies can apply for other cannabis-related permits.
This license is required for companies or institutions handling controlled substances, including cannabis and cannabinoids. It applies to activities such as manufacturing cannabis-based products, handling cannabinoid raw materials, or conducting scientific research involving controlled cannabis compounds.
Sanitary Authorization is issued for specific cannabis-based medical products and allows them to be legally marketed in Brazilian pharmacies with a physician’s prescription. Companies must submit detailed documentation on product formulation, safety data, manufacturing processes, and quality-control measures. The authorization is typically valid for up to five years, subject to regulatory compliance.
Certain institutions including universities, research centers, and pharmaceutical developers, may receive authorization to cultivate cannabis for scientific and medical research purposes. Cultivation is subject to strict monitoring, security controls, and traceability requirements, and the cannabis produced cannot be sold commercially.
Patients with a valid medical prescription may apply for individual import permits to obtain cannabis-based medicines from international suppliers. This authorization allows patients to legally import products for personal therapeutic use when prescribed by a physician and approved by ANVISA.
Some patient associations can obtain court-issued permissions allowing them to cultivate cannabis and produce cannabis extracts for their registered members. These judicial rulings provide an alternative pathway for patient access, particularly for individuals who cannot afford imported products or pharmacy-dispensed cannabis medicines.
Operating legally in Brazil’s cannabis sector requires understanding the various fees and charges imposed by ANVISA. These fees cover licensing, inspections, compliance monitoring, and regulatory approvals. Costs vary depending on the type of license, scope of operations, facility size, and number of products.
Key fees include:
Obtaining a cannabis license in Brazil requires strict compliance with regulations set by ANVISA and, in some cases, coordination with the Ministry of Agriculture (MAPA). The process varies depending on whether the operation involves cultivation, research, manufacturing, or import/export.
Below is a step-by-step overview:
Applications are submitted to the local ANVISA office. Each request is reviewed for completeness, accuracy, and compliance with the applicable RDC rules.
ANVISA conducts an on-site inspection to verify security measures, traceability systems, and adherence to Good Manufacturing Practices (GMP) if applicable.
Securing a cannabis license in Brazil is a complex process, and applicants often encounter challenges that can delay approval or result in denial. Some of the most common application pitfalls are listed below.
Operating within Brazil’s cannabis sector requires continuous adherence to strict regulatory standards established by ANVISA. Companies authorized to manufacture, import, distribute, or research cannabis-based products must maintain strong compliance systems to ensure transparency, product safety, and traceability. Ongoing regulatory obligations typically involve audit readiness, security controls, accurate record keeping, labeling standards, and strict limitations on marketing activities.
Licensed companies must remain prepared for regulatory inspections and compliance audits conducted by ANVISA or other relevant authorities. Facilities handling cannabis or cannabis-derived products are required to implement strict security protocols, including controlled access areas, surveillance systems, and secure storage for raw materials and finished products.
In addition to physical security, companies must maintain comprehensive documentation and traceability systems. This includes detailed records of cannabis sourcing, cultivation batches (where applicable), manufacturing processes, product testing results, and distribution logs. Traceability is critical in Brazil’s regulatory model, ensuring that every product can be tracked from its origin through the supply chain to the final patient. Records must be retained for regulatory review and updated regularly to ensure full compliance with pharmaceutical standards.
Cannabis-based products sold in Brazil must comply with strict labeling and product information requirements. Labels must clearly identify the product’s composition, cannabinoid concentration, dosage instructions, and safety warnings. Information must be accurate, transparent, and approved as part of the product’s regulatory authorization.
Advertising and promotion of cannabis-based medical products are highly restricted. Companies are not permitted to directly market cannabis products to patients or make therapeutic claims outside approved regulatory guidelines. Communication about cannabis-based medicines is generally limited to healthcare professionals and must remain informational rather than promotional.
In addition, cannabis products must undergo quality and safety testing to ensure consistency and compliance with pharmaceutical standards. Testing typically verifies cannabinoid concentrations, purity levels, and the absence of contaminants such as pesticides, heavy metals, or microbial agents.
Failure to comply with Brazil’s cannabis regulations can result in significant penalties. Regulatory authorities may impose administrative fines, suspension of licenses, product recalls, or the revocation of regulatory authorizations. In more serious cases, particularly those involving unauthorized production or trafficking, criminal penalties may apply under national drug control laws.
Because of these risks, companies operating in Brazil’s cannabis sector must invest in robust compliance programs, internal audits, and regulatory monitoring systems. Maintaining strict adherence to regulatory requirements not only ensures legal operation but also builds credibility within Brazil’s developing medical cannabis market.
Brazil is rapidly emerging as one of the most promising cannabis markets in Latin America, driven by growing patient demand, evolving regulatory policies, and increased acceptance of cannabis-based therapies within the healthcare system. Although the country maintains a conservative regulatory framework, the expansion of medical cannabis access and the gradual development of local production capabilities are creating significant opportunities for investors, pharmaceutical companies, and research institutions.
Brazil’s cannabis sector has experienced rapid expansion over the past decade, driven primarily by the growth of the medical cannabis market and increasing patient access to cannabinoid-based therapies. Since the regulatory framework allowing cannabis-based products was introduced by ANVISA, the number of patients and market revenues have risen sharply.
Industry reports from 2024 indicate that more than 672,000 Brazilian patients were receiving medical cannabis treatments with over 2,180 medicinal cannabis products catering to various needs with over 55,000 doctors authorized to prescribe cannabis-based products sold in pharmacies. By 2025, about 873,000 patients were estimated to be using cannabis-based therapies across the country.
Brazil’s medical cannabis market generated approximately R$852 million (about USD $170 million) in revenue in 2024, with market revenues surpassing R$1 billion annually in 2025. By 2034, the market is forecasted to hit about USD $1.54 billion.
Beyond the current patient base, the untapped potential of the market remains substantial. Industry analysts estimate that approximately 6.9 million Brazilians could potentially benefit from cannabis-based treatments, suggesting that the current patient population represents only a fraction of the possible demand.
Additionally, Brazil’s broader cannabis economy, including medical cannabis, adult-use legalization scenarios, and industrial hemp has been estimated to have a long-term potential market value of roughly R$26 billion (around USD $5 billion) if regulatory reforms expand cultivation and commercialization.
Given Brazil’s population of more than 210 million people, its expanding healthcare system, and increasing physician acceptance of cannabinoid therapies, the country is widely considered one of the largest emerging cannabis markets globally and a key growth hub for the Latin American cannabis industry.
Domestic demand for cannabis-based therapies has grown rapidly over the past decade with a large portion of demand currently comes from patients seeking treatments for conditions such as:
The absence of a fixed list of qualifying medical conditions allows physicians to determine treatment eligibility based on clinical judgment, which has contributed to increased patient access and broader therapeutic applications.
Another major driver of demand is the role of patient associations, which have helped expand access to cannabis-based therapies. Several Brazilian patient organizations have obtained court authorization to cultivate cannabis and produce extracts for their members, creating alternative access pathways for individuals who cannot afford imported pharmaceutical products.
Although Brazil currently relies heavily on imported cannabis-based medicines to meet domestic demand, the country has significant potential to become a major exporter of cannabis-derived pharmaceuticals and industrial hemp products if regulations expand to permit broader commercial cultivation. At present, most cannabis products available in Brazil are imported from countries with established cannabis industries, including Canada and parts of Europe. However, policymakers and industry stakeholders increasingly recognize the economic opportunities associated with developing a domestic cannabis supply chain.
Brazil possesses several structural advantages that could support the growth of a competitive export industry. One of the most important is its favorable agricultural environment. The country’s tropical and subtropical climates provide suitable growing conditions for cannabis cultivation throughout much of the year. Brazil also has extensive experience managing large-scale agricultural production, particularly in globally competitive crops such as soybeans, sugarcane, coffee, and corn. This existing expertise in commercial agriculture could be leveraged to support the cultivation and processing of cannabis and hemp at scale.
In addition, Brazil’s strategic geographic position within Latin America provides access to several emerging cannabis markets in the region. Countries such as Colombia, Uruguay, Mexico, and Argentina are gradually expanding their cannabis industries, creating opportunities for regional trade and collaboration. Brazil’s established logistics infrastructure and international trade relationships could facilitate the export of cannabis-derived pharmaceutical products to neighboring markets once regulatory barriers are addressed.
Brazil also has a growing pharmaceutical manufacturing sector, which could support the development of cannabinoid-based medicines and medical formulations. With the appropriate regulatory framework, Brazilian pharmaceutical companies could potentially produce cannabis extracts, oils, and pharmaceutical-grade cannabinoid products for both domestic use and international markets.
If regulatory reforms eventually allow large-scale cultivation and processing, Brazil could develop a competitive position in several segments of the global cannabis supply chain, including pharmaceutical cannabis production, cannabinoid extraction, medical formulations, and industrial hemp products such as fibers, food ingredients, and nutraceuticals.
Despite regulatory restrictions, several areas of the Brazilian cannabis sector present promising business opportunities:
Can patients grow cannabis at home in Brazil?
Home cultivation of cannabis is generally prohibited under federal law. However, some patients are granted permission through court orders for personal medical use. These judicial authorizations are typically issued on a case-by-case basis, often in response to affordability or access challenges related to imported cannabis products.
Does Brazil allow commercial cannabis cultivation?
Brazil does not currently permit large-scale commercial cultivation of cannabis for recreational or broad medical production. Most cannabis-based products are imported. However, limited cultivation is allowed for research purposes and, in some cases, for patient associations or individuals with court authorization. Regulatory discussions are ongoing, and future reforms may expand domestic production and licensing opportunities.
Are cannabis-based products manufactured locally in Brazil?
Most cannabis-based products in Brazil are currently imported, as large-scale domestic cultivation remains restricted. However, some products are formulated or packaged locally under authorization from ANVISA. In addition, certain patient associations are permitted—through court orders—to produce cannabis extracts for their members, creating limited local supply channels.
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