On March 10, 2020, the Brazilian Health Surveillance Agency (“ANVISA”) Resolution 327/2019 entered in force to establish the necessary requirements to manufacture, import, sell and prescribe Cannabis-based products for medicinal use in the country. Such Resolution is a simplified way that ANVISA has found to regularize such products for medicinal use as a consequence of the increased demand for their regularization and commercialization in the Brazilian market.
However, ANVISA believes that there are no sufficient data to prove that most of these products are effective and safe for consumption. In this way, and considering the public outcry, the Agency has created certain rules for companies and healthcare professionals that intend to provide patients with Cannabis-based products for medicinal use as a therapeutic alternative for their health condition. ANVISA has been justifying its regulation according to the expertise of other countries on the subject, such as Canada, Germany, United States, Portugal and Israel.
On April 22, 2020, ANVISA published the first sanitary authorization allowing the company Prati-Donaduzzi to produce and sell Cannabis-based products for medicinal purposes. It took forty-two (42) days between the submission of the company’s request and the publication by ANVISA of the sanitary authorization in the Brazilian Official Gazette.
In order to help the companies better understand the regulation of Cannabis-based products for medicinal use in Brazil, the Public and Regulatory Law team of Demarest Advogados has prepared a brief overview, in the format of Questions & Answers below, regarding ANVISA’s Resolution 327/2019 and prior clarifications on the matter.
Finally, it is of great importance to point out that up to the present time, Resolution 327/2019 is the main rule concerning the manufacture, importation and selling of the products in Brazil. However, such rules may be amended or repealed and, for that reason, it is essential to constantly follow up with a specialized lawyer before engaging with the cannabusiness segment in Brazil.