The National Health Surveillance Agency (Anvisa) prohibited the importation of cannabis in natura as of this Thursday (20). The prohibition extends to any part of the plant, and the focus is on the so-called “flowers”, which concentrate the medicinal and psychoactive active principles of cannabis, which is the marijuana plant.
The use of cannabis-based medicines has NOT changed. Since 2015, Anvisa has allowed the import of products with active ingredients extracted from the plant. And as of 2019, the regulatory agency has allowed the sale of products with cannabis substances in pharmacies.
The loophole for obtaining authorization to import cannabis flowers lay in the fact that previous Anvisa resolutions did not contain a clear veto. In order to obtain an import authorization, the patient needed to have a medical prescription for the in natura consumption of plant varieties that offer only high concentrations of cannabidiol (CBD).
These varieties of so-called “CBD flowers” are not sources of THC, which is the substance associated with adult and recreational consumption (which is illegal in Brazil). In general, consumption of CBD in natura can be done via inhalation or through food preparation.
In the pharmaceutical industry, CBD is used as an analgesic, sedative and anticonvulsant in the treatment of diseases such as multiple sclerosis, epilepsy, Parkinson’s, schizophrenia and chronic pain, among others.
Combustion and inhalation
Now, with the ban on importing parts of the plant, Anvisa has formally justified that there is no robust evidence on the efficacy and safety of using parts in natura, in addition to the risk of diversion to non-medicinal uses. Furthermore, it reaffirmed that combustion and inhalation are not safe modes of medicinal consumption.
“Considering that, so far, there is no robust scientific evidence proving safety, in addition to the high potential for diversion for illicit purposes, the importation of products composed of the Cannabis plant in natura or parts of the plant, including the flowers, is not allowed,” wrote Anvisa.
“The combustion and inhalation of a plant are not pharmaceutical forms/routes of administration of a product intended for health treatment”, states the agency in technical note number 35/2023.
The agency also informed that there will be a transition period for orders already placed.
“As of 07/20/2023, new authorizations/proof of registration will not be granted for the importation of the Cannabis plant in natura, parts of the plant or flowers. There will be a transition period of 60 days to complete the imports that are already in progress and the authorizations to import Cannabis in natura, parts of the plant and flowers already issued will be valid until 9/20/2023”, he added.
