Brazil authorizes use of cannabis-based medicine imported from Colombia

RIO DE JANEIRO, BRAZIL – The marketing authorization and the use of the medicine in Brazil is foreseen in a resolution by the Brazilian Health Regulatory Agency (ANVISA) published on Friday (29)  in the Federal Gazette.

An oral solution based on cannabidiol (CBD), the medicine is the fourth with this active ingredient to be authorized for use in Brazil.

The authorized product has a concentration of 50 milligrams per milliliter with up to 0.2% of tetrahydrocannabidiol (THC) and must be imported pre-packaged and ready for exclusive distribution in pharmacies and drugstores, according to the resolution.

Interested parties will only be able to order it with a specific and restricted medical prescription “when they have exhausted other therapeutic options available in the Brazilian market,” the body clarified.

According to the health regulator, the license to import the medicine has an initial term of 24 months and its indication and use will be the responsibility of the prescribing physician, who will have to advise the patient that the product is based on cannabidiol.

ANVISA approved the regulation of cannabis-based products in December 2019 and until now had only authorized the use of 3 other drugs with this active ingredient in Brazil.

Brazilians with diseases treated with these medicines can only import them, since their commercialization and production is still banned in the country.

In January last year, faced with the growing demand for these medicines and patients’ complaints about the difficulties in accessing them, ANVISA relaxed the rules for their use, limiting them to medical prescription to avoid impairing treatments.

Medicines that use marijuana active ingredients, such as cannabidiol or tetrahydrocannabidiol (THC), are recommended in Brazil for the treatment of diseases such as epilepsy, multiple sclerosis, autism, chronic pain and Parkinson’s disease.

Despite greater acceptance of the plant’s medicinal use, the law in Brazil still punishes the cultivation, commercialization, possession and consumption of marijuana with imprisonment.