Medicinal Cannabis >

It is estimated that in March 2023, the National Health Surveillance Agency (ANVISA) registered an increase of almost 100% in requests for import of products based on the plant compared to 2021. In 2022, ANVISA issued around 80 thousand new authorizations for the import of products based on medicinal Cannabis.

Furthermore, it is estimated that in 2022, the sale of medicinal Cannabis in pharmacies grew by around 304%, evidencing the existence of a market in broad expansion, reinforced by the reduction of approximately 35% in the average price of these products for the same period.

Indicators show that revenue in pharmaceutical retail was approximately R$$63.3 million. Furthermore, in 2022, Anvisa issued around 80 thousand new import authorizations.

In Brazil, the so-called Regulatory Framework for Medicinal Cannabis was established through the Collegiate Board Resolution (RDC) No. 327/2019, which regulates the granting of Sanitary Authorization, for an initial period of 5 years, for manufacturing and import, as well as establishes requirements for the marketing, prescription, dispensing, monitoring and inspection of industrialized products containing plant-derived or phytopharmaceutical active ingredients from Cannabis sativa for medicinal purposes for human use.

Among the various legal requirements that must be observed by industry agents and medication users is the chemical composition of Cannabis sativa products, which must predominantly contain Cannabidiol (CBD) and be limited to a maximum of 0.2% of Tetracannabidiol (THC), except for palliative purposes.

There are also parallel markets, unfortunately not regulated for now by Brazilian authorities, such as the construction, plastic, food (which uses seed derivatives), cosmetics (which uses oil, seeds, terpenes and cannabinoids from the plant), plant cultivation and raw material production industries, but which may timidly operate in these segments, on a case-by-case basis.

Our team offers the following services:

• Legal advice and opening of legal vehicles linked to medicinal cannabis, such as cannabis associations, startups specializing in medicinal cannabis, manufacturers, importers, marketers and/or distributors;
• Obtaining Health Authorizations for the import of medicinal cannabis;
• Legal advice on the import of plant derivatives for the purpose of manufacturing CBD as a pharmaceutical-grade phytopharmaceutical with ANVISA;
• Registration of products derived from medicinal Cannabis with ANVISA;
• Obtaining preventive habeas corpus for planting by patients;
• Obtaining an injunction for the import of raw materials and manufacture of products derived from medicinal Cannabis in favor of compounding pharmacies;
• Legal advice on Cannabis ETFs (Exchanged-Trade Funds) and NFTs (Non Fungible Tokens) in Brazil.