8/9 June 2022
The Brazilian Health Regulatory Agency (ANVISA) has published a list of cannabis products that will have automatic approval by the agency for individual importation by Brazilian patients. According to the agency, the aim of the list is to reduce the time for registration approval and enable patients to have faster access to cannabis-derived products.
The previous text of RDC 335 already brought important advances for the population's access to medicinal cannabis products. The RDC 335, of January 24, 2020, defines the criteria and procedures for the importation of cannabis-derived products by individuals, for their own use, upon prescription by a legally qualified professional, for health treatment.
However, the growing demand for importation of these products has resulted in a long time for processing of applications, which can impact the health of patients. The Agency has seen applications increasing from 896 in 2015 to 19074 in 2020, and as of mid-September 2021, there have already been 22028 requests by patients to import cannabis products for medicinal use.
The new Resolution establishes that the approval of the registration will occur in a simplified procedure in the case of products derived from Cannabis contained in Technical Note 37 published on the Agency's website. The list also includes a large number of CBD preparations. Thus, at the time of registration, only the regulatory aspects of the product will be evaluated, i.e., if the product to be imported is produced and distributed by establishments duly regulated by the competent authorities in their countries of origin for the activities of production, distribution, or marketing.
ANVISA is also working on updating their systems, in order to allow the automatic approval of the registration in the cases of products included in the list pre-defined by the Agency.
Imports remain subject to inspection by the competent authorities at ports, airports, borders, etc., and the following documents must be presented at each importation:
The Prescription will now only be evaluated by the authorities mentioned above, avoiding duplicity of verification and allowing greater speed in the registration approval stage. However, ANVISA emphasizes that it will be up to the applicant to correctly fill out all the data requested in the application form.