The authorization for the marketing and use of the medicine in Brazil, that can be sold exclusively in pharmacies and with a prescription, is foreseen in a resolution of the National Health Surveillance Agency (Anvisa, regulator) published this Friday in the Official Gazette.
The medicine, a cannabidiol (CBD) -based oral solution, It is the fourth with this active principle whose use is authorized in Brazil.
The authorized product has a 50 milligram per milliliter concentration with up to 0.2% tetrahydrocannabidiol (THC) and it will have to be imported already packaged and ready for exclusive distribution in pharmacies and drug stores, according to the resolution.
THOSE INTERESTED MAY ONLY REQUEST IT WITH A SPECIFIC AND RESTRICTED PRESCRIPTION “WHEN THEY HAVE EXHAUSTED OTHER THERAPEUTIC OPTIONS AVAILABLE IN THE BRAZILIAN MARKET,” THE ORGAN CLARIFIED.
According to the health authority, the license to import the medicine has un initial period of 24 months and its prescription and use will be the responsibility of the doctor who prescribes it, who will have to warn the patient that the product is based on cannabidiol.
Anvisa approved the regulation of cannabis-based products in December 2019 and until now it had only authorized the use of three other medicines with this active principle in the country.
Brazilians with diseases treated with these medicines can only import them, since its commercialization and production is still prohibited in the country.
In January of last year, given the increase in demand for these medicines and the difficulties in accessing them reported by patients, Anvisa made the rules for its use more flexible, and limited them to medical prescription, so as not to harm the treatments.
Medicines using principles marijuana actives, such as cannabidiol or tetrahydrocannabidiol (THC), are recommended in Brazil for treatments for diseases such as epilepsy, multiple sclerosis, autism, chronic pain and Parkinson’s disease.