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Brazil: Marijuana-Based Medicine Authorized for Use

(Nov. 29, 2016) On November 22, 2016, the Board of Directors of the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) unanimously approved the inclusion of medicines based on derivatives of cannabis sativa (cannabidiol and tetrahydrocannabinol – substances found in marijuana) in list A3 of Administrative Act No. 344/98. (Portaria SVS/MS No. 344/98 (May 12, 1998), ANVISA website.)

Administrative Act No. 344 provides for the technical regulation of substances and medicines subject to special control, and list A3 specifically deals with narcotics. The update of the Administrative Act will make it possible to register a medicine with ANVISA that is based on such derivative substances.  (Id.)

The Board also decided that laboratories must record derivatives in concentrations of not more than 30 mg of tetrahydrocannabinol (THC) per milliliter and 30 mg of cannabidiol per milliliter. Products with a higher concentration than that remain banned in the country.  (Canabidiol e THC: Norma Permitirá Registro de Produto [Cannabidiol and THC: Standard Will Allow Product Registration], ANVISA website (last updated Nov. 23, 2016).)