Around the world, countries are discussing cannabis legalization for medical, research, and/or recreational use. Brazil is no different. On June 14th, 2019, ANVISA (the Brazilian Health Regulatory Agency) published two public consultations related to cannabis, representing another step in the legalization process.

The first consultation focuses on the technical and administrative requirements for cultivating cannabis for medicinal and scientific purposes. According to the draft, the cultivation of the plant must, along with other access control guarantees, be done indoors and behind security doors accessible through biometrics. The draft also provides that the cultivation can only be done by legal entities that receive special authorization from ANVISA.

The second consultation sets out the specific procedures for registering and monitoring drugs based on cannabis, its derivatives, and its synthetic analogues. The draft establishes, among other regulations, that the initial product registration will be valid for three years. Before the drug can then be renewed, companies will have to report the benefits and risks of the drug to ANVISA.

The comment period for the public consultations will be open from June 21 to August 20.


Henrique Frizzo is a partner in Trench Rossi Watanabe, specialized on Public Law, Government Affairs and Regulatory, with focus on consultancy matters.