Brazil speeds up import of cannabis-derived products
Brazil’s drug regulator Anvisa has streamlined the import of cannabis-derived medical products by reducing the approval time for individuals registering with a medical prescription.
The increasing demand for the import of these goods has led to delays in assessment processes at Anvisa, which may be detrimental to patients, the watchdog declared.
In six years, a surge of 2,400 percent has been reported in the number of orders—an average growth of 400 percent a year. In 2015, orders totaled 896. In 2020, this number stood at 19,074.
“By mid-September 2021, patients had placed 22,028 orders for products derived from cannabis for therapeutic purposes,” Anvisa stated, adding that the COVID-19 pandemic “aggravated the scenario, leading to an even sharper increase in import orders of these products.”
The resolution, Anvisa stated, stipulates that patients’ registration must be evaluated “in a simplified process in the case of cannabis-derived products listed in the Technical Note issued by Anvisa’s Management for Controlled Products and published on the agency’s web portal.”
Thus, during the registration process, assessment will consider the product’s status alone—“in other words, if the product to be imported is produced and distributed by established licensed by the relevant authorities in their country of origin for the activities of production, distribution, and trade,” the authority reported.
Anvisa is also working to update its systems and plans soon to enable the automatic approval of registration in the aforementioned cases.
