The resolution of the National Agency for Sanitary Surveillance (Anvisa), which regulates trade, is already in force
As of Tuesday (10/3), the import and marketing of cannabis products for medical purposes are authorized in Brazil. Anvisa's resolution, limited for medical purposes, requires the presentation of a Type A medical prescription and the signing of a consent form. According to the standard, the products can be sold in pharmacies and the patient must present a prescription signed by a doctor, to purchase products with a THC content not exceeding 0,2 %.
Beyond this quantity, the products can only be prescribed to terminally ill patients who have already exhausted all forms of palliative treatment.
Products cannot have a trade name, and the patient and their legal guardian must sign an informed consent form at the time of purchase. The label should have a black stripe and specific warnings, such as the possibility that the product will cause physical or psychological dependence.
To produce the cannabis derivative, which is not considered a drug, but a product for medicinal use, Anvisa will issue a health authorization to the laboratory authorizing the offer. Normally, the agency will grant a registration to the laboratory, but the rule does not apply in this case.
One more step for Brazil?
The regulation of Anvisa, from this Tuesday, allows patients suffering from various neurological diseases, from chronic pain to Parkinson's disease, to legally access the product, as is already done in countries such as Germany, the United States, Canada and Israel.
Since 2016, the use could be requested from Anvisa, but the authorization only came after the agency had analyzed the case by case and the acquisition was made abroad.