ANVISA approves sale of cannabidiol-based drugs, but vetoes its cultivation in Brazil
On December 3rd, 2019, the National Health Surveillance Agency (ANVISA) approved the registration and production of cannabis-based drugs on national territory, but vetoed the proposal for growing the plant exclusively for medicinal and scientific purposes.
The regulation will come into force 90 days after publication in the Federal Official Gazette and will be in force for 3 years.
The resolution creates a new class of “cannabis-based” products, which means it will not be classified as a medicine. The products may be marketed exclusively in pharmacies and drugstores without manipulation and upon prescription, being authorized especially to those suffering from serious diseases such as severe epilepsy and tumors. The products may be for oral and nasal use, in tablets, liquids, as well as oils.
With such decision, product manufacturers who choose to import cannabis substrate should import the semi-finished raw material, and not the plant or part thereof.
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