The importation and commercialization of medications and industrialized products containing cannabidiol (CBD) and/or tetrahydrocannabidiol (THC) for medicinal use has been permitted since 2015 and has been growing annually in Brazil. In February 2025, ANVISA (Brazilian Health Regulatory Agency) undertook a revision of ANVISA RDC nº 327/2019, which set forth requirements for the importation, commercialization, medical prescription, and dispensing of Cannabis products, and which shall be replaced by ANVISA RDC nº 1.015/2026, effective as of 05/04/2026.
Additionally, definitive rules were approved for the local cultivation and manufacturing of such products for medicinal, pharmaceutical, or research purposes (ANVISA RDC nº 1.012/2026 and ANVISA RDC nº 1.013/2026).
On an experimental basis, ANVISA also established a regulatory sandbox for conducting controlled tests and generating evidence on experimental techniques and technologies involving products or services related to Cannabis sativa, specifically: (i) cultivation intended for medicinal purposes; (ii) production of herbal pharmaceutical inputs; and (iii) development, preparation, and supply of Cannabis-based preparations for medicinal use (ANVISA RDC nº 1.014/2026).
