By the end of March, 18,650 patients had received authorization for medical cannabis in Brazil. Such colossal figures in the industry’s early stages have led to a surge in imports of non-registered medical cannabis products. This is based on data released by the South American country’s health regulator.

“Compassionate use” – a type of access to non-registered products – is popular throughout Brazil, where guidelines for a medical cannabis market were drawn up in December. Within the space of the last year, Brazil’s medical cannabis imports have steadily grown. 

An influx of approvals, which must be carried out by the National Sanitary Surveillance Agency (ANVISA), have contributed to Brazil becoming the largest Latin American cannabis market. 

Growth in Brazil’s medical cannabis imports also indicate increased need for plant-based medicines; a doctor and ANVISA must sign off on a patient recommendation, regardless of the product’s THC (tetrahydrocannabinol) content.

Majority of Brazil’s medical cannabis imports contain CBD

CBD is legal in Brazil, but only with a prescription and when used as “medicine”; as opposed to a “supplement”. Although it is uncertain as to precisely how much CBD was imported during the first quarter of 2020, data shows that as many as 3,000 patients received authorization to import non-registered CBD products — representing 25 percent growth since the previous quarter and 123 percent more than Q1 2019.

Despite initially being valid for a one-year period, authorizations from 2019 were extended for an additional 12 months at the beginning of 2020. “Sanitary authorization” was also granted at the end of last year for products that have demonstrated medical efficacy in clinical trials. However, this category of products – which can be produced domestically and sold in pharmacies – only constitutes one approved application so far.

Good Manufacturing Practice certification

Based on the fresh regulations for medical cannabis in Brazil, ANVISA will continue accepting GMP certifications until December 2022. Those certifications will be awarded by health agencies of PIC/S countries. It should be noted that after this time, just ANVISA certifications will be granted. 

A specific requirement for anyone hoping to produce and sell medical cannabis products in Brazil is that the product is able to maintain its shelf life. This can prove tricky, due to the often sweltering climate. Once approved, certifications can only be granted for five years. Renewals are also bound within this timeframe. After the five years is up, medical cannabis products in Brazil must either be eliminated from the market or registered as a normal medicine.