ANVISA Approves First Marijuana-based Medicinal Product in Brazil

RIO DE JANEIRO, BRAZIL – The National Health Surveillance Agency (ANVISA) approved on Wednesday, April 22nd, the registration of the first marijuana-based product in the country.

It is a phytopharmaceutical product that contains cannabidiol and a concentration of less than 0.2 percent THC, the substance with psychotropic effects.

The product may be sold in pharmacies, provided there is a medical prescription. ANVISA states that the drug will be used in cases where there is no therapeutic alternative, but failed to specify which diseases would be benefited.

ANVISA has not reported the name of the drug. The product is manufactured by the Prati-Donnaduzzi company.

The agency approved a resolution in December 2019 to allow registration of cannabis-based products.

Under pressure from the Bolsonaro government, the agency at the time rejected authorization for the planting of marijuana for medicinal and research purposes.

The new resolution has established a specific category for cannabis-based products. In the past, only drugs containing substances extracted from cannabis could be registered, provided they were based on solid clinical studies.

This kind of research is expensive and, according to people in the industry, difficult to conduct for more basic products, such as herbal medicines.

Brazil currently allows the sale of the drug Mevaty, which costs over R$2,000 in Brazil, recommended for moderate to severe spasticity related to multiple sclerosis.

It is expected that other products will become available in pharmacies, with lower complexity, such as phytotherapeutic products with the new ANVISA rule.

Source: Estadão Conteúdo