Brazil drug regulator approves three cannabis-based products

Brazil’s national drug regulator Anvisa recently approved three cannabis-based products: Cannabidiol Belcher 150 mg/mL, Cannabidiol Aura Pharma 50 mg/mL, and Cannabidiol Greencare 23.75 mg/mL.

Anvisa’s rules allow cannabis-based products to be sold in Brazil provided they have been authorized by the agency. In compliance with the norms stipulated by the authority, the goods should observe the limit of a maximum 0.2 percent of tetrahydrocannabinol (THC).

Cannabidiol may only be requested in type B prescriptions, and only if other treatments are unavailable, as stipulated by law.

These substances, Anvisa declared, are products, not medicines, as the latter would require clinical trials to prove effectiveness.

Thus far, Anvisa stated, scientific research has not yet developed methods to assess enough evidence and data for such products to be considered medication. In all, 14 cannabis-based drugs have been granted authorization in Brazil.