As mentioned in our previous post on this topic, patent applications for pharmaceutical products or processes must be submitted to ANVISA (The Brazilian Health Surveillance Agency) for prior consent based on a public health analysis.
The government lists many cannabis-derived products such as THC and other synthetic cannabinoids as prohibited substances. In the past, applications were routinely shelved before a substantive examination could take place in the Brazilian PTO, discouraging new products from entering the market.
However, the position has been slowly changing since 2015. ANVISA started approving the import of cannabis based products (subject to medical subscriptions), leading to the first marketing approval in this area in 2017 (for the medicine Mevatyl®).
In 2020, ANVISA allowed for the creation of a new category of products derived from cannabis. The new Rule came into force on March 10, allowing companies interested in manufacturing and marketing these products to apply for authorizations. The regulation makes clear that the trade in cannabis products will be exclusively under strict prescription control (the rules vary significantly according to the concentration of THC in the product).
Just in April, ANVISA published its authorization for two new products based on cannabis. The approved products were oral cannabidiol solutions in concentrations of 17.18 mg / mL and 34.36 mg / mL, with up to 0.2% THC. With the authorizations obtained, the applicant company can now import ready for use products and start marketing in the country. Under the agencies rules, cannabidiol may be prescribed when other therapeutic options available in the Brazilian market are exhausted.
We are continuing to monitor the developments on Cannabis-based products in Brazil and abroad. If you have any questions about this matter do not hesitate to get in touch with us here.