Brazil Approves RSHO For Importation For Cancer Treatment

Brazil’s health authority, ANVISA, has given it’s seal of approval for cancer patients within their country to begin importing Real Scientific Hemp Oil™ for the treatment of cancer symptoms. With a prescription from their physician, patients may have access the hemp-derived cannabis oil. This is the first time any federal government of a large country has supported the use of any cannabis product to treat cancer.

The Brazilian government up to the time of this post’s publishing has yet to conduct clinical trials on CBD (cannabidiol) oil as a cancer treatment, leading the charge with anecdotal evidence combined with existing scientific research found on large medical journal sites, working hand in hand with the expertise of the nation’s physicians when making their decision to include cancer among the approved indications for which RSHO™ CBD hemp oil can be imported.

Medical Marijuana, Inc., the makers of RSHO™, made it clear in a press release that they are managing the situation cautiously. “We are right now tempering our excitement because this is a process and it needs to be approached carefully and scientifically,” stated Dr. Stuart Titus, CEO of Medical Marijuana, Inc.

The news comes in the midst of a rapid increase in new cancer cases recently diagnosed within Latin America, and unfortunately that trend is only expected to continue over the coming decades. The increase has been felt more in Brazil than in neighboring countries. According to current statistics, Brazilians have a 20% chance of being diagnosed with cancer prior to turning 75. Roughly there are half a million new cases of cancer in Brazil annually, and every year nearly 225,000 Brazilians die from cancer every year. Even though Brazilians are diagnosed with cancer at a lower rate than more developed countries in North America and Northern Europe, the mortality rate from cancer in Brazil is just over twice that of the U.S., meaning effective treatments are desperately being searched for.

Also on the radar for the people of Brazil is a rare genetic mutation to the p53 gene, responsible for tumor control at a cellular level in humans, which has been found to have a higher prevalence in regions in Southern Brazil. Those who are identified to have this mutation may experience cancer incidences at up to ten times the rate of the rest of the general population, often diagnosed with cancer at an early age, and some may even experience multiple tumors during their lifetime.

Worldwide, we see continuing trends of cancer growth among developing countries like Brazil, China, and India, stemming from the adoption of unhealthy Western diets and habits, such as smoking tobacco products. As these populations take on the unhealthy lifestyles of modern Western countries, their cancer rates increase. However, unlike Western countries, which are finally seeing progress in their fight against cancer with prevention campaigns and innovative new treatments, cancer centers in these countries are struggling to keep up. The World Health Organization has predicted a 70% increase in new cancer cases worldwide over the next two decades. Now more than ever, alternatives to costly and time consuming options for fighting cancer are needed in these developing nations.

Before Medical Marijuana, Inc.’s entry into the Brazilian market, all cannabis products, including those from hemp, were illegal in Brazil. Through a grassroots campaign to raise awareness and the establishing of HempMeds® Brasil, in 2014, RSHO™ became the first legal cannabis product in Brazil, a nation of over 200 million people, when ANVISA removed cannabidiol (CBD) from Brazil’s prohibited substance list.

How To Import RSHO CBD Oil To Brazil

The import authorization of unregistered prescription drugs in Brazil is possible when an exceptional import request is made for personal use valid for one year. Through this formal request, Anvisa will consider the authorization of purchase.

Step 1
Required Documents

1. Medical Report:

  • CID
  • patient’s name,
  • Pathology name
  • Description of the case, justification for the use of medicine not registered in Brazil compared to existing therapeutic alternatives already registered by ANVISA

2. Prescribing

  • Patient Name
  • Product name
  • dosage
  • quantitative necessary
  • Treatment time,
  • Date
  • Stamp and signature of the doctor (with CRM)

3. Disclaimer

Step 2
Send Documents

ANVISA has simplified the import of products cannabidiol based procedure.

The exceptional authorization issued for the realization of import is required because the products contain banned substances that require a control directly supervised by the competent authority, in compliance with international agreements. There are medicines registered in Anvisa to cannabidiol base.

The authorization will be informed through official letter issued by Anvisa, it is valid for one (1) year and the authorized number will be equivalent to that period, and may be imported at once or in installments.

After receiving the authorization Exceptional import during the period of validity before each shipment, the patient or legal guardian must submit to ANVISA through email, prescription with consistent quantitative with the quantity to be shipped.

For the acquisition of the product based on Cannabidiol, the patient or guardian must complete the following steps:

First patient registration at ANVISA:

I-Form for Import and Use of Product to Cannabidiol Base: 

Conducted electronically through the link 

II- professional Report legally qualified containing the description of the case, CID, justification for the use of product not registered in Brazil compared with existing alternative therapies registered by Anvisa and previous treatments;

III- prescription product by a legally qualified professional must containing patient’s name and product, dosage necessary quantitative treatment time, date, signature and prescriber Registration number in your class council; and

IV- Statement of Responsibility and Enlightenment for the exceptional use of the product

If there is a change of any data from the initial prescription of the product during the validity of the registration and / or the authorized quantity of product based on Cannabidiol, in combination with other cannabinoids, is insufficient for this period, the applicant must submit new prescription and request necessary changes.

Registration Renewal:

The renewal of the registration must be made by filing:

  • New professional report legally qualified with the evolution of the case after using the product based on Cannabidiol;
  • New prescription containing mandatory patient’s name and product, dosage necessary quantitative treatment time, date, signature and prescriber Registration number in your class council.

If there is a change of any of the data provided in the form for Import and Use of Product to Cannabidiol Base contained in the existing registration, it should also be presented at time of renewal.

The Agency requests immediate notification in the event of any subsequent event to prevent or stop the use of products already imported.

Final provisions and adjustments:

Patients who already have exceptional authorization issued before the resolution will have until the expiration of the validity of authorization granted to request a new registration, in accordance with the requirements of this Resolution.

Product Import: After approval of the registration, import can be done by Import License registry – LI in the Integrated Foreign Trade System – SISCOMEX IMPORT, for accompanied baggage or express shipping.

Upon receipt of the email sent by the Agency, the interested party should proceed with the procedures for the acquisition of the product and report the code for tracking product (Air Waybill – AWB, object number, etc …) to GGCOE by e- mail before the arrival of the product in Brazil.

ANVISA address

Office of the Chief Executive Officer (GADIP)

National Health Surveillance Agency (ANVISA)

Sector Industry and Supply (SIA)

Excerpt 5, Special Area 57- Lot 200

CEP: 71205-050, Sia Section 5 – Guará, Brasilia, Distrito Federal

To give quickly to process electronic copy of this request shall be sent to the following

e-mail: ; , .

Get Your Product

A change occurred in the Brazilian legislation for the import of medicines.

The shipment will no longer be moored in the formal service, it is no longer necessary customs broker and will be exempt from tax and will not be charged storage.

Note: The exemption is only for shipments with a declared value below 3,000.00 usd.

Remittances above 3000.00 usd, the customs broker and tax collection is required.

Necessary documents:

  • Prescription (copy);
  • Office of Anvisa Authorization (copy);
  • child’s birth certificate (copy), proves the child’s relationship with the responsible person requesting the material;
  • RG and CPF (copy) responsible and the child;

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