The National Health Surveillance Agency (ANVISA) has given the green light for the marketing of cannabidiol oil in Brazil. This product will be legally available in the Latin American country to medical patients that possess a special prescription, which must be renewed every two months, and have exhausted all other current treatment options as it is not considered a medicine.
Brazilian health authorities approved the sale of cannabidiol oil, the first cannabis-based therapeutic product to be marketed in the country’s pharmacies, on Wednesday, April 22nd, 2020.
This is the first registration granted by the National Health Surveillance Agency (ANVISA), linked to the Ministry of Health of Brazil, after the body unanimously approved last December the regulation that opened space for the sale of cannabis-based medicines.
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Medical patients can now legally access cannabidiol oil
Cannabidiol (CBD) oil can be sold in Brazilian pharmacies to cannabis medical patients who present a special control prescription, which must be renewed every 60 days.
However, the authorization is not a free pass for cannabidiol oil, as the agency has some guidelines anyone interested in acquiring these products has to follow. According to the National Health Surveillance Agency (ANVISA), cannabidiol oil “is not a medicine”, although it has a therapeutic effect on some specific medical conditions.
ANVISA is an autonomous agency that regulates most, if not all products and services in the Latin American country. The institution makes sure that products follow the necessary health controls and regulations before they can be sold in any store.
The agency’s authorization provides that the CBD oil, with a THC (Tetrahydrocannabinol) concentration of less than 0.2%, can be recommended to patients who have no other treatment alternative with satisfactory results.
This is a positive step in the right direction. Several research studies have shown that cannabis-based products could be considered as a viable treatment for some ailments in the near future, both alone and in tandem with other medicines, boosting their effects.
ANVISA approval was given with some limitations
“Cannabidiol (CBD) may be prescribed when other therapeutic options available on the Brazilian market are exhausted,” the National Health Surveillance Agency (ANVISA) said in a statement.
According to the institution, the indication and use of cannabis-based products are the responsibility of the attending physician, who must inform the patient of the health risks and the possible adverse effects.
Currently, Brazil is lagging behind with its cannabis laws and policies in comparison with other South American countries. That is mainly because the marketing of cannabis and cannabis-based products, without a special permit, it’s illegal and criminally prosecuted.
However, as of 2006, Brazilians are legally allowed to possess and even cultivate cannabis if it can be proven that the plant or any other product that derives from it is only for personal and private use.
Nevertheless, in December 2019, the National Health Surveillance Agency (ANVISA) approved the creation of a new category of cannabis products.
The resolution, which came into force on March 10th, gave the green light for companies interested in manufacturing and marketing these cannabis products to request the order and authorization from the agency.
This regulation stipulates that the trade will be done exclusively by means of special control medical prescription in cases in which the concentration of THC (Tetrahydrocannabinol) is less than 0.2%.
On the other hand, products with a higher THC (Tetrahydrocannabinol) concentration may only be prescribed to terminal patients or patients with no other treatment alternatives.
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First published in El Comercio, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.
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