The Resolution of the Brazilian National Health Surveillance Agency (ANVISA) comes into force regulating products derived from Cannabis.
On March 10, 2020, Resolution RDC n° 327/2019 came into force, providing for procedures for the granting of Sanitary Authorization for manufacturing and import, as well as establishing requirements for marketing, prescription, dispensing, monitoring and the inspection of Cannabis-based products for medicinal purposes for human use, among other measures.
According to such Resolution, products derived from Cannabis manufactured and marketed in Brazilian territory must have, among other aspects, predominantly cannabidiol (CBD) and no more than 0.2% tetrahydrocannabidiol (THC). Products with a THC content higher than 0.2% can be manufactured and marketed, provided that they are intended for palliative care exclusively for patients without other therapeutic alternatives and in irreversible or terminal clinical situations, so that their administration remains restricted to compassionate use.
In addition, products may not bear trade names, and must be designated by the name of the plant derivative or phytopharmaceutical accompanied by the name of the responsible company, and advertising and distribution of “free sample” for Cannabis products is prohibited.
Lastly, in its Article 18, sole paragraph, the Resolution even establishes that companies must import the pharmaceutical input in the forms of plant derivatives, phytopharmaceuticals, in bulk, or industrialized products, prohibiting the importation of the plant or parts thereof.
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