The Anvisa Collegiate Board updated Annex I of Portaria SVS / MS No. 344/98, a standard that lists the plants and substances under special control in Brazil, including those of prohibited use. The update included in the list A3 drugs registered in Anvisa derived from Cannabis sativa, in a concentration of at most 30 mg of tetrahydrocannabinol (THC) per milliliter and 30 mg of cannabidiol per milliliter. The decision was unanimously taken at the Ordinary Public Meeting held on Tuesday (22) and should be published in the Official Gazette of the Union in the next few days.
“We have updated the ordinance exactly so that, if registration is granted, doctors will know how this medication will be prescribed,” says Anvisa’s CEO Jarbas Barbosa. “Thus, the drug will be prescribed in the same way as other psychotropic drugs already in use in Brazil. That is, it will have the black stripe and can only be sold with a special medical prescription, which is that form that the doctor has numbered. When sold, the pharmacy will have the obligation to register it in the National Drug Control System, which is managed by Anvisa, so that we can monitor if there is any deviation or abuse in its prescription. ”
The product will be indicated for the treatment of symptoms of adult patients with moderate to severe spasticity due to multiple sclerosis (MS) and will be marketed with the same prescription rules that are currently used for narcotic and psychotropic drugs for medical use, with special prescriptions and Registration of prescriber and buyer data in Anvisa’s special monitoring system.