The total number of authorizations granted to Brazilian patients to import cannabis for medical purposes has exceeded 10,000 at the end of June 2019. Since the program's launch in 2014, it has been the largest number of authorizations ever granted.
In Brazil, after obtaining authorization from the government, patients can import a maximum amount of therapeutic cannabis on a case-by-case basis for up to one year. Authorizations may however be renewed each year. In most cases, only CBD oils are imported because the Federal Council of Medicine, the body responsible for regulating the medical profession, has restricted the prescription of CBD, which now can only be used to treat epilepsy refractory in children and adolescents.
The first shipment was delivered by MedReleaf Corp. from Canada in 2017. The purpose of the export was to treat the symptoms of Sofia Langenbach, a child with the CDKL5 genetic syndrome, who caused her to develop refractory epilepsy and Severe seizures that, for her, had been relieved only by the use of medical cannabis. Her mother, Margarette Santos de Brito, currently president of APEPI ("Support for research and patients treated with medical cannabis"), the first and largest association of cannabis patients in Brazil, had already won a landmark trial to grow his own cannabis. She is one of the leading advocates of the legalization of therapeutic cannabis in Brazil for many years,easier access to medical cannabis.
Last June, ANVISA (the Brazilian ANSM) proposed two projects that, if approved, would regulate the national cultivation of cannabis for medical purposes and create a framework for registration of products without completed clinical trials. After receiving the comments on the proposals until 19 August, ANVISA announced that it had received a total of 1,554 comments. About two-thirds of the contributions considered that the ANVISA proposals would have a positive impact. More than 60% of participants identified themselves as potential "consumers", said the agency in its statement. A final decision is expected by the end of October.