On January 27, 2020, the National Health Surveillance Agency (“ANVISA”) published the Resolution RDC no. 335/20 (“RDC 335”), which defines the criteria and procedures for import of products derived from Cannabis (“Products”) by individuals for their own use during health treatment.
The RDC 335 is already in force and its new rules are promising, since the period of import order analysis for these Products may be reduced, as follows:
(i) Fewer documents and information to be provided to ANVISA. From now on, the patient or his/her legal representative will be able to request the import by sending the medical prescription and filling a proper form to ANVISA;
(ii) No obligation to inform the quantity to be imported in advance. This monitoring is now carried out at points of entry of products into the country and the quantity imported cannot exceed the medical prescribed quantity;
(iii) The validity period of the authorization given by ANVISA for the import made by the patients is increased by 2 (two) years;
(iv) The legal representative may now request the importation on behalf of the patient.
Valid authorizations issued between 1/27/2019 and 1/27/2020 will have their expiration date postponed for one more year, in accordance with item (iii) above.
Currently, ANVISA takes approximately seventy-five days to complete the analysis of the import request for products derived from Cannabis. It is expected that such period will be considerably reduced now that RDC 335 is in force.
The Life Sciences team at Demarest is available to answer any questions on the subject.