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Generic Legislation for BRAZIL

Generic Legislation
ANVISA Ordinance No. SVS/MS No. 344/1998 [as amended by Resolution RDC No. 79 of 23 May 2016 (synthetic cannabinoids) and Resolution RDC No. 175 of 15 September 2017 (synthetic cathinones)] (Dispõe sobre a atualização do Anexo I (Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial) da Portaria SVS/MS nº 344, de 12 de maio de 1998) (pt)
In May 2016, the Brazilian National Health Surveillance Authority (ANVISA) approved Resolution No. 79/2016, introducing a new approach for the scheduling of synthetic cannabinoids in Brazil. This new approach consists of a “generic” scheduling system, allowing Brazil to control substances by using their chemical group (“structural class”) and is used alongside with the list (“nominal”) approach, which schedules each substance individually.

In September 2017, ANVISA approved the use of a generic approach for synthetic cathinones in Resolution No. 175/2017. Both generic approaches are accompanied by guidelines to assist with the identification of conforming substances.

The new approach was motivated by the challenges posed by New Psychoactive Substances and the need to establish innovative scheduling processes to meet their quick development. The generic legislation benefited from technical and scientific information from several sources, including the UNODC document “Recommended methods for the identification and analysis of synthetic cannabinoid receptor agonists.”

The generic legislation was drafted by a working group comprised of experts from ANVISA, the Federal Police, and the National Secretary of Public Security, including representatives from forensic laboratories. It is in line with CND Resolutions 55/1 of March 2012, 56/4 of March 2013, 57/9 of March 2014, and 58/11 of March 2015.

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