In January this year, the National Health Surveillance Agency (“ANVISA”), through its Collegiate Board, published the Resolution of the Collegiate Board nº 335 (“Resolution”), which defined the criteria and procedures for importing a product derived from cannabis by individuals (for their own use), upon presentation of a prescription by a legally qualified health professional.

The Resolution defines the procedure for authorizing the importation of products derived from cannabis, their customs clearance and importation clearance, as well as the intermediation of the importation of these products. The Resolution also establishes the characteristics of the products derived from cannabis that are allowed, and these products must be industrialized, intended for medicinal purpose (using a substance derived from cannabis).

The importation can be carried out either by the person who will use the products, or by his legal guardian or proxy legally constituted in cases where the user is not legally able to sign the import request. Importation may also be intermediated by (a) a hospital entity, (b) a government unit related to the health care area, and (c) a health plan operating companyfor exclusive care to the patient previously registered with ANVISA.

The production and distribution of cannabis-based products is authorized only in establishments duly regulated by the competent public authorities in their respective countries of origin for the exercise of such activities.

For the request to import cannabis derived products, as well as their subsequent use, patients must perform a personal registration with ANVISA, on the Federal Government Services Portal. The approval, or refusal, of the registration request mentioned above will only depend on an assessment by ANVISA of the documents made available.

After approval by ANVISA, the registration will be valid for two (2) years and its renewal must be requested by presenting a new prescription for the use of cannabis-based products.

It is important to note that, while the registration is in force, the same prescription may be used in more than one ANVISA office to support the import consent request, provided that the intended import volume does not exceed the prescribed quantity.

Noteworthy, in April 22, 2020 ANVISA approved the registration of the first cannabis-base product produced by Parati-Donnaduzzi, a phytochemical product cannabidiol derivative with THC concentration below 0.2%.

We are at your disposal for any further clarifications regarding the products and consumption of cannabis-derived products.