Brazil’s Cannabis Products’ Regulation

The global market for medicinal cannabis has grown increasingly each year. In Brazil, such growth was even stronger due to the new regulations established by the Brazilian National Health Regulatory Agency (Anvisa ), in particular Collegiate Board Resolution No. 327/2019 (RDC 327/2019), published on December 11, 2019. This rule, also known as Regulatory Framework for Cannabis in Brazil [“Marco Regulatório da Cannabis no Brasil”], establishes procedures for granting a health license for manufacturing and importing, and also sets requirements for the marketing, prescription, dispensing, monitoring and auditing of Cannabis Products.

After nearly two years in force, RDC 327/2019 has already enabled several Cannabis Products to enter the Brazilian market. Currently, there are 18 cannabis-based medicinal products registered with the Agency, which are available for purchase in regular pharmacies and drugstores. A noteworthy highlight is that, of these 18 products, eight are manufactured from the vegetable extract of the Cannabis Sativa and 10 from the CDB phytopharmaceutical.

In order to assist companies and investors to understand the Brazilian regulation on Cannabis Products, Demarest’s Life Sciences team prepared a booklet addressing the main topics on the regulation. This booklet is generic and informative and does not constitute a legal opinion for any specific operation or business.