Anvisa prohibits importation of cannabis in natura, even if it is for medicinal use

The discussion about the use of CBD products continues to be strong around the world and in Brazil it would be no different.

In a nutshell, the Brazilian framework related to the CBD products is:

• RDC 327/2019, which sets forth the procedures for granting Sanitary Authorization for manufacturing and importation, as well as establishing requirements for the commercialization, prescription, dispensation, monitoring, and inspection of CBD products for medicinal purposes, and

• RDC 660/2022, which provides the criteria and procedures for the importation of CBD products, by individuals, for their own use, upon prescription by a legally qualified professional, for health treatment.

In the context of this discussion, on July 19, 2023, Anvisa published the Technical Note 35/2023/SEI/COCIC/GPCON/DIRE5/ANVISA, which prohibited the importation of the Cannabis in natura, parts of the plant or flowers . The clarification considers that the current regulation of CBD products in Brazil does not include permission to use parts of the plant, even after the stabilization and drying process or even in scratched, crushed, or pulverized forms.

Furthermore, the Agency justified that there is a risk of diversion for non-medicinal purposes and that there is no robust evidence of medical efficacy and safety.

Deadlines:

As of July 20, 2023, new authorization submissions will not be granted for the importation of CBD products. There will be a transition period of 60 days to complete imports that are already in progress. The authorizations already issued for the importation of Cannabis in natura, parts of the plant and flowers will be valid until September 20, 2023.

Automatic registration list:

Technical Note 35/2023 establishes the list of products for personal import that will have automatic registration approval. It should be noted, however, that this is an exceptional import, and the products on the list do not have efficacy, quality or safety evaluated by Anvisa.

For further assistance, our Life Sciences & Healthcare team is available via email: lifesciences@soutocorrea.com.br.