Photo courtesy of The Green Fund
The new medicine is based on cannabidiol (CBD), one of the main compounds within the cannabis plant, and it will be prescribed to treat conditions like epilepsy. The medicine will be sold exclusively in pharmacies only through a written prescription by a physician.
The permission to market and use cannabis-based medicine comes from the National Health Surveillance Agency (Anvisa, regulator), which was first published in the Official Gazette. The medicine is a liquid solution for oral use containing cannabidiol (CBD), and it’s also the fourth legalized medicine with the non-psychoactive cannabis compound to be authorized in Brazil.
The new treatment contains a concentration of 50 milligrams per milliliter with up to 0.2% tetrahydrocannabinol (THC). According to the decision published in the Official Gazette, the imported treatment must be packaged upon arrival and ready for exclusive distribution in drug stores and pharmacies.
The Anvisa decision also notes that those interested in using the cannabis-based medicine may only request it with a “specific and restricted prescription when they have exhausted other therapeutic options” available in the Brazilian market.
According to Official Gazette, health authorities say the license to import the CBD treatment has an initial term of 24 months. Additionally, the prescription and use will be the sole responsibility of the physician prescribing the medicine; they must inform patients that the product is derived from cannabis and contains CBD.
Since Anvisa permitted the regulation of cannabis-based products in December 2019, Brazil has only seen three authorized medicines with the compound known as CBD, but the new medicine marks the fourth official cannabis-based treatment. Because Brazil is still prohibiting the commercialization and production of cannabis and related products, Brazilians looking to treat conditions with said medicines can only import them from Colombia.
There is an alleged demand for cannabis-based medicines around Brazil, and patients reported having difficulties accessing said medicines. Because of this, Anvisa began to relax its rules in January of last year. Now, Anvisa limits the use of cannabis-based products solely through medical prescription to avoid hindering other treatments that might be in place.
Physicians in Brazil are now looking towards the active ingredients in cannabis like CBD and THC to treat conditions like epilepsy, multiple sclerosis, autism, chronic pain, and Parkinson’s disease.
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