Brazil Cannabis Market – Business Plan Templates

Brazil, the most populated nation in South America, has roughly 216.1 million people.
In December 2019, National Sanitary Surveillance Agency (ANVISA) approved regulations for launching medical cannabis sales in the country. According to current regulations, nonregistered medical cannabis products can be imported only by individual patients after approval by a doctor and ANVISA. More than 40,000 patients obtained permits from ANVISA to import medical cannabis from 2014, with roughly 50% of those prescriptions given in 2021 alone, according to data from ANVISA.

Population 2022 (m)	216
GDP 2022 (US$ t)	1.92
Share of total farming land worldwide	5%
Total spending on health 2020 (US$ b)	143
Total medical cannabis patients 2022 (est.)	160,000
Total of potential cannabis users (est.)	4.5%
Source: World Bank/Prohibition Partners

At the end of 2019, Brazil approved new rules allowing cannabis products without proven efficacy via clinical trials to obtain a “sanitary authorization,” valid during the early years of commercialization. Pharmaceutical-quality requirements include:

Good Manufacturing Practice certification. The new regulations determined that until December 2022, ANVISA accepts GMP certifications issued by health agencies of PIC/S countries. After December 2022, only ANVISA certifications are allowed.
Data demonstrating that the quality of the product remains stable throughout its shelf life in the climatic conditions commonly found in Brazil.

The judicial authorizations for cultivation, the growth of the associations and the new regulations were announced in August 2020. A total of 42 home or association cultivation permits were awarded via the justice system from January to July 2020, a 200% increase compared to 2019.

Latin America and the Caribbean Cannabis Markets

A new resolution of the Federal Council of Medicine (CFM), published in October 2022, made the therapeutic indication for medical cannabis in Brazil more restrictive. Under the resolution 2324/2022, prescriptions for THC and any other cannabis compounds other than cannabidiol (CBD) were prohibited. CBD, in turn, had its use restricted to the treatment of only two pathologies in children and adolescents with very specific epilepsies: Dravet and Lennox-Gastaut syndromes (progressive encephalopathy associated with difficult-to-control seizures) and Tuberous Sclerosis Complex (characterized by the growth of benign tumors in various organs and epilepsy). Sales of medical cannabis in Brazil in 2022 were estimated at $37.1 million, according to Prohibition Partners.

Sales of medical cannabis in Brazil in 2022 were estimated at $37.1 million, according to Prohibition Partners. More than 160,000 patients obtained permits from ANVISA through three forms of access, imports, patient associations and pharmacies, from 2014, with roughly 75% of those prescriptions given in 2022 alone, according to data from ANVISA.

On March 14, 2023, the 1st District of the Superior Court of Justice (STJ) suspended all legal actions relating to the cultivation of cannabis for medical, pharmaceutical and industrial purposes until a precedent is set for the matter by the STJ.

In May 2023, Clever Leaves Holdings Inc. (Colombia) has received Brazilian GMP certification from ANVISA to produce cannabis products for Brazilian patients.

In January 2024, Ease Labs Pharma (Brazil) received ANVISA approval to commercialize a pharmaceutical product containing 2.5% CBD and up to 0.2% THC. Ease Labs Pharma is the first Brazilian pharmaceutical company to be fully vertical and focused on cannabis products.

In February 2024, MediPharm Labs Corp. (Canada) has received a GMP certificate from Brazil’s National Sanitary Surveillance Agency for the production of finished cannabis products.

The Brazilian medical cannabis market is expected to reach $280 million in 2025, according to a 2023 report by industry observer Kaya Mind.

Brazil Cannabis Market Infographics

Cannabis Cultivation Business Plan Sample, Brazil

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