|The products are manufactured in the United States and can, from now on, be marketed in the country. Photo: Marcelo Camargo / Agnesia Brasil|
The National Health Monitoring Agency (Anvisa) announced, Thursday (15), the licensing of two new hemp based products (a plant popularly known as “marijuana”). The reported releases are CBD-based oral solutions at concentrations of 17.18 mg / mL and 34.36 mg / mL, with up to 0.2% THC.
Both products are manufactured in the United States and may, henceforth, be marketed in Brazil. The applicant sent the request to Anvisa in October 2020. However, it took the agency 90 days to evaluate and approve the materials.
As stipulated in the rule, cannabidiol – responsible for the relaxing effect on human health – can be prescribed by prescription “when other treatment options available on the Brazilian market have been exhausted,” as described by Anvisa.
In addition, the agency proves that the declaration of cannabis-based products is the responsibility of the physician, who must inform patients of the use of the phytopharmaceutical in question.
In December 2020, Anvisa approved the creation of a new class of products based on hemp. The Standard Decision took effect in March 2021. From that date, companies interested in manufacturing and selling CBD-based products can apply for approval through the federal government website.
Trade should take place exclusively by means of a special control recipe, as provided for in the rule. In products with a concentration of 0.2% tetrahydrocannabinol (THC), another chemical component of cannabis, the prescription occurs through a Type B (blue) prescription that is valid for up to 60 days. This is the case for Thursday approved phyto-pharmaceuticals.
At concentrations higher than this value (0.2% THC), the prescription is given to patients in the final stages of life, when other treatment alternatives are closed, with a prescription Type A (yellow), which has a shelf life of 30 days.
Anvisa reports that the current stage of research is not sufficient to approve hemp-based products as medicines.
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