Through Technical Note No. 35/2023, ANVISA (the Brazilian National Agency for Sanitary Surveillance – the Brazilian FDA) prohibited the importation of the Cannabis plant in natura, whole or in parts (including its flowers), as of July 20, 2023.
This decision does not have immediate retroactive effect, so ANVISA provided for a transition period of 60 days for the completion of imports that are already in progress. In addition, the Agency considered that the authorizations already granted for the import of the plant in natura will be valid until September 20, 2023.
ANVISA justified its decision based on the absence of concrete evidence that proves the safety of consuming parts of the plant in natura, in addition to the potential risk of deviations for non-medicinal purposes. The Agency also reinforced that the combustion and inhalation of the plant are not pharmaceutical forms/administration routes of a product intended for health treatment.
It is worth mentioning that this prohibition does not affect the importation of products derived from Cannabis, importation and use of which continue to be subject to prior authorization from ANVISA.