RIO DE JANEIRO, BRAZIL – The new import guide by prescription of a legally qualified health professional must be completed at the gov.br Portal, by the patient or by a duly appointed legal representative.
According to the National Health Surveillance Agency (ANVISA), the electronic form seeks to speed up the service of requests, removing steps such as screening of manual cases.
The straightforward completion of the document provided on the portal gives rise to a procedure that may or may not be authorized.
“It is important to point out that nothing changes in relation to the step by step requests. The form for placing orders has been improved, in addition to the introduction of a new gateway for applications,” explains the agency, in a note.
“The application stages of the import review process remain the same and include the need for the patient to have seen a doctor and obtained a prescription for the medication. After that, a registration with ANVISA is required and the import review must be requested.
“Following the technical evaluation of the request, the agency authorizes the medicine purchase, which is what enables the import by the patient”.
In addition to the medical prescription, ANVISA’s authorization is a mandatory requirement to import any product based on cannabidiol – a chemical substance derived from Cannabis sativa (the plant popularly known as marijuana), which is included in the list of substances subject to control under Decree No. 344, published by the Ministry of Health in 1998.
The criteria and procedures for exceptionally importing cannabidiol based products are detailed in ANVISA’s Resolution No. 17 of May 2015.
The resolution establishes that the import may also be mediated by hospital bodies, government agencies linked to the health area, health plan operators or civil bodies legally representing patients, for the exclusive and targeted care of patients previously registered with ANVISA.
In these cases, the patient must inform, when registering in the portal, the data of the person responsible for the import mediation.
Also according to the text, the import of cannabidiol-based products in association with other cannabinoids (among them, Tetrahydrocannabinol – THC, active ingredient of the marijuana plant, with hallucinogenic properties, and which requires control as provided in international covenants to which Brazil is signatory) listed in the resolution should be made from a vegetable derivative.
Furthermore, it must have a THC content lower than that of cannabidiol; be produced and distributed by establishments duly regulated by the relevant authorities in their countries of origin and contain an analysis certificate, with a cannabidiol and THC specification and content that complies with the regulatory requirements of the relevant authorities in their countries of origin.
Source: Agência Brasil