How to have access in Brazil to treatment with products based on cannabidiol?
The National Health Surveillance Agency (ANVISA) authorizes the exceptional importation of products based on cannabidiol, in association with other cannabinoids, per physical person, for their own use, by prescription of a legally qualified professional, to Health care. According to the criteria of RDC 17/2015.
Understand clearly not to have any further questions about this topic.
Understand the procedure.
Who can request this?
Patients or their legal representatives who have a proven and indispensable medical need for the product.
These are the necessary steps:
Consult a physician
Consult with a specialist doctor who can assess your case and guide you appropriately in the treatment .
Defined treatment will require 3 documents for you to request approval from ANVISA :
- Product prescription (recipe)
- Statement of responsibility and clarification
1. Product prescription (recipe)
It must be issued by a legally qualified professional containing compulsorily: the patient’s name; Trade name of the product; Dosage (daily dose), quantitative required (Specify the product presentation); Treatment time; Date, signature, stamp and registration number and class advice of the prescribing professional.
Issued by a legally qualified professional: containing the patient’s name, case description, name of the disease and ICD, justification for the use of product not registered in Brazil in comparison with the existing therapeutic alternatives registered by Anvisa, as well as the previous treatments, date, signature, stamp, registration number of the class board of the prescriber professional.
3. Declaration of responsibility
This document shall contain the declaration of responsibility and clarification for the exceptional use of the product, as well as the signature and stamp of the legally authorised professional, signature of the patient or guardian, place and date.
With all scanned documents it is necessary to carry out the request for approval to ANVISA in the citizen’s portal.
After approval of the registration and obtaining the authorization, the importation can be made:
- In-person purchase and statement for accompanied baggage,
- Remote or online purchase and express shipping (with all documentation) or
- Import by registration of import licensing in SISCOMEX IMPORT.
Documentation for importation
It must be presented in each importation, directly at Anvisa’s stations at airports, the prescription by a legally qualified professional, containing compulsorily: name of the patient registered with Anvisa, product name, dosage, quantitative be imported, date, signature and registration number and class advice of the prescribing professional.
It is important that the craft of exceptional authorization issued is in possession of the patient or legal guardian for surveillance purposes.
The patient or guardian should import only the quantity authorized by Anvisa, being allowed to import only once or installments.