CBD Oil Brasil

Want to buy legal CBD oil in Brazil? Learn about Brazilian CBD laws, where to buy it, and how to import medical CBD. In December 2019 the Brazilian Board of Health published a new resolution creating a new regulatory procedure for companies to import and commercialise Cannabis products, a topic that has been under a lot of discussion in Brazil. This article analyses the new regulation.

How & Where to Buy CBD Products in Brazil (Summer 2020)

Up until 2015, Brazil prohibited cannabis and its derivatives regardless of the THC content. Today, hemp-derived CBD is regulated under the Brazilian government and is permitted for medicinal use only.

Accessing CBD in Brazil can be challenging, and you should know the laws if you want to protect yourself from legal troubles.

Luckily, we’ve put together this article to break down all you need to know about cannabis laws in Brazil, and how you can purchase CBD.

Summary: Buying CBD in Brazil

  1. CBD in Brazil is permitted only for medical use with authorization from the National Sanitary Surveillance Agency (Anvisa).
  2. There is only one company in Brazil — CBD Vida — selling CBD-based drugs through prescription and medical report.
  3. Imported cannabis products must not exceed 30 mg of THC per mL and 30 mg of CBD per mL.

Best CBD Oil in Brazil:

Elixinol Extrato Rico Em CBD Canabidiol (Brazil Exclusive)

$0.12

Endoca CBD Oils

€0.08 – €0.09

Kat’s Naturals Relax THC-Free Sublingual CBD Oil

$0.20 – $0.40

Hemp Bombs CBD Oil

$0.07 – $0.17

Nature’s Script CBD Oils

$0.07 – $0.17

Charlotte’s Web CBD Oils

$0.05 – $0.19

How to Buy CBD Products in Brazil (Legally)

As of August 2019, you can order CBD in Brazil. CBD Vida is a startup based in São Paulo. The company sells CBD-based supplements through prescription and medical report.

Currently, it’s the only company that supplies CBD products directly within Brazil.

The way CBD is currently regulated in Brazil, your best option is to buy your CBD online and have it shipped to your address. You’ll need a medical card to be able to do this (information on how to apply listed below).

After you receive approval from Anvisa that you can import medical CBD, search for companies that ship CBD to Brazil. If you find a company you want to order from that doesn’t ship to Brazil, you can use a mail forwarding service like Shipito to get it to your door.

Mail forwarding companies will give you an American address to use during checkout. The CBD company will ship to Shipito’s warehouse, where staff will put new stamps on the package and forward it to your final address.

Don’t forget: your CBD product must not contain more than 30 mg of THC per milliliter and 30 mg of CBD per milliliter.

Demystifying Brazilian CBD Laws

Brazil prohibits industrial hemp and its derivatives. However, CBD received its legal stamp in 2015, after the National Sanitary Surveillance Agency (Anvisa) authorized the compound for therapeutic use.

There are no current Brazilian companies growing hemp, but Anvisa allows the import of CBD exclusively for medical purposes.

Let’s take a look at the hemp laws, so you don’t step on the red line when buying CBD in Brazil.

Brazilian law prohibits cannabis cultivation, processing, and sales. This restriction applies to both marijuana and industrial hemp. In the eyes of the law, there is no distinction between hemp and marijuana. As a result, there is no specific legislation on industrial hemp.

Under the law 344/98 by Anvisa, cannabis is on the list of prohibited plants that can produce psychoactive substances.

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The Law 11.343/06 — known as the Anti-Drug Law — prohibits the cultivation, harvesting, and exploitation of plants from which drugs may be produced, except in the case of legal regulation [1].

The lack of precise regulation leaves hemp on the list of banned plants.

Penalties on the Possession and Consumption of Drugs and Banned Plants

In Brazil, there is no prison sentence for possession or consumption of small amounts of drugs for personal use. However, Brazil has no defined criteria regarding “small amounts of drugs.”

Anyone who buys and carries drugs for personal use without authorization is subject to the following penalties:

  1. A warning
  2. Community service
  3. Mandatory educational programs [2].

There‘s also no prison sentence for individuals who, for personal consumption, grow or harvest plants for the preparation of small quantities of a substance. Again, there is no official guide to “small quantities.” It’s up to the judge to decide whether the amount of the banned substance was intended for personal use or drug trafficking.

If you sow, cultivate, or harvest — without authorization — plants that constitute the raw material for drug preparation, with the intention to sell and trade, you may receive a prison sentence of five to fifteen years.

How to Obtain a Medical License for Cannabis in Brazil

The medical licenses to obtain CBD for treatment are granted on a case-by-case basis.

Let’s take a more detailed look at how you can obtain a medical license for CBD.

CBD Importation Process

If you plan to purchase medical CBD in Brazil, you should know that the process will take some time, and you MUST acquire all necessary documentation.

Without the complete and correct documentation, your chances to be approved for medical CBD are slim.

1. Medical Consultation and Prescription

If you have a medical condition you’d like to purchase CBD for, you need to consult a doctor for a prescription.

The prescription must contain:

  • Your name
  • The product name
  • Dosage
  • Quantity required and treatment time
  • Date, signature, stamp, and registration number of the doctor’s council class
2. Patient Registration with Anvisa

One of the essential steps to obtain permission for CBD is to register as a patient with Anvisa.

For this, you must send the following documentation to the Agency:

  • Application form
  • Medical prescription
  • Medical report
  • Statement of responsibility.

You can find the electronic application under the “What application form should I fill out” item.

If the electronic application isn’t available (which happens from time to time), you can email the form to [email protected] with the rest of the required documents.

3. Analysis of the Application by Anvisa

After you complete the application process, the Agency reviews your request for CBD authorization.

4. Authorization for Importation by Anvisa

After Anvisa reviews your request, they will notify you if you can import medical CBD.

The authorization is granted via email with an electronic signature and a verifier code.

After you receive the authorization, you can purchase your CBD by express shipping, through Siscomex or luggage accompanied.

Anvisa will inspect your product at the airport.

NOTE: You should carry the authorization with you, regardless of where you’re located — within or outside Brazil.

A Brief History of Cannabis Laws in Brazil

Portuguese colonists brought cannabis to Brazil in the early 19th century for its fiber. Hemp fiber was used for packaging coffee — its most exported product today.

The term “cannabis” includes both industrial hemp and marijuana. African slaves, who were brought over by the Portuguese to Brazil, knew marijuana for its recreational use and psychoactive effects.

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Following the increase in marijuana use by slaves, the Rio de Janeiro City Council banned the import of cannabis — including low-THC industrial hemp — in 1830.

Between 1840 and 1889, the Brazilian Empire went through political and economic restructuring. Emperor Dom Pedro II considered industrial hemp a viable crop, so he re-introduced its cultivation in Brazil hoping it would endorse the economic development.

However, hemp was (once again) banned due to its association with recreational marijuana use in 1932. Since then, the laws on cannabis in Brazil — including hemp — only became stricter.

Today, the Brazilian law doesn’t differentiate between industrial hemp and marijuana, and its cultivation is prohibited.

Regulation of Cannabis products in Brazil

Since 2015, substances derived from Cannabis sativa L, tetrahydrocannabinol (THC) and cannabidiol (CBD) are allowed for medicinal use under certain restrictions imposed by the Brazilian Health Regulatory Agency (ANVISA). To qualify for ANVISA’s clearance, cannabis-based pharmaceuticals must comply with ANVISA’s Resolutions. [1] These require clinical data demonstrating the pharmaceuticals’ safety and efficacy for their intended indication and the Good Manufacturing Practice certification of the manufacturer, among others.

Cannabis sativa L remains, however, listed as a plant that cannot be cultivated, harvested, exploited, imported, exported, traded, extracted, handled or used in Brazil. There are currently bills of law under review in National Congress to remove Cannabis Sativa L as a prohibited plant, but there is no estimate of when and how those bills will be passed into law. In the current legal context, activities involving Cannabis sativa L are viewed as criminal conduct, with the exception of plant cultivation and harvest for scientific or medicinal purposes, authorised by the Ministry of Health for a determined period of time.

Nevertheless, with a view to expediting the access of patients to Cannabis products, ANVISA published Resolution RDC No. 327 on 9 December 2019 (‘RDC 327 of 2019’) to regulate the manufacture, import, commercialisation, prescription, dispensation, monitoring and inspection of a new category of products named ‘Cannabis Products’. ANVISA created a new, simplified pathway for the clearance of Cannabis Products, called Sanitary Authorisation. This is valid for five years only, during which time this authorisation can be converted into a marketing authorisation for pharmaceuticals.

The regulatory landmark for Cannabis Products in Brazil is still subject to review and RDC 327 of 2019 will be revisited by December 2022.

Cannabis Product

As defined in RDC 327 of 2019, ‘Cannabis Product’ refers to any product manufactured for medical use that contains, as active ingredients only, Cannabis sativa L plant derivatives or phytopharmaceuticals.

Cosmetics, tobacco products, healthcare products or food items based on Cannabis spp (the name of the species of Cannabis Sativa L) and its derivatives do not qualify as Cannabis Products for medical purposes.

Under RDC 327 of 2019, the Cannabis Products:

• must primarily have CDB and THC; [2]

• must be oral or nasal administration only;

• must be of pharmaceutical quality for human use;

• must be duly registered with the competent authorities in their countries of origin if imported;

• cannot bear trade names, and must be identified by the name of the corresponding plant derivative or phytopharmaceutical and by the name of the company responsible for the product;

• cannot contain isolated substances of synthetic or semi-synthetic origin, except those serving as excipients;

• cannot contain substances that may be potentially toxic at the dosages being used;

• cannot be of modified release, nanotechnological and pegylated;

• cannot be commercialised in the form of a plant drug made of Cannabis spp or its parts, even after stabilisation and drying processes, or in its shredded, ground or pulverised form, even if it is made available in any pharmaceutical form;

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• cannot be advertised; and

• cannot be distributed as free samples.

Sanitary Authorisation

The Sanitary Authorisation for manufacturing and/or importation of Cannabis Products is granted by ANVISA via a simplified procedure, initiated upon prior application made by the interested company. This is provided that the Cannabis Product satisfies the requirements set forth in RDC 327 of 2019 regarding quality control, labelling, packaging and traceability of the product, and also that the applicant itself meets the regulatory requirements.

Within this context, the applicant (either a manufacturer or an importer) must:

  • be a legal entity incorporated in Brazil;
  • bear an Operating License (AFE), Special Authorisation (AE) and Pharmaceuticals Good Manufacturing Practice Certificate (GMP) related to the Product manufacturer located in Brazil or abroad; and
  • in the case of an importer, bear a Pharmaceuticals Good Distribution Practices Certificate (CGDP).

Until 9 December 2022, ANVISA will accept GMP certification or an equivalent document issued by the sanitary authorities of countries recognised by ANVISA. During such period, the company must apply for GMP certification by ANVISA.

The Sanitary Authorisation will be valid for a maximum of five years, during which time the company can pursue the product’s approval through the conventional pharmaceutical registration pathway. If the Cannabis Product is not approved as a pharmaceutical, then (upon expiration of the Sanitary Authorisation) the corresponding Cannabis Product can no longer be commercialised, imported or manufactured in Brazil.

Manufacture, import and commercialisation

As cultivation of Cannabis sativa L is still prohibited in Brazil, local manufacturers must import the active ingredient in the form of a plant derivative, phytopharmaceutical, bulk or industrialised product.

Hence, Brazilian legislation does not allow for any importation of:

  • Cannabis spp;
  • Cannabis spp’s parts;
  • product in the form of the Cannabis spp plant or its derivatives; or
  • cosmetics, tobacco products, healthcare products and food items based on Cannabis spp and their derivatives.

Cannabis Products can only be commercialised by pharmacies (that do not compound pharmaceuticals) or drugstores.

Prescription/indication

Cannabis Products may only be prescribed by a physician duly licensed in Brazil and responsible for the patient. Patients, or their legal representative, must also sign an Informed Consent Form (TCLE) to use Cannabis Products.

Prescription of Cannabis Products is permitted when other therapeutic alternatives available in the Brazilian market have been exhausted. Products with more than 0.2 per cent THC can be prescribed for palliative care solely to patients without other therapeutic alternatives and in irreversible or terminal clinical condition. Palliative care is defined as full, active care directed at patients with illnesses that no longer respond to curative treatment, notably aimed at ensuring the best quality of life for patients and their family members.

Post-commercialisation

The responsibility for reporting on any adverse events relating to the use of Cannabis Products lies with prescribing physicians, any healthcare professionals and the company holding the Sanitary Authorisation. The latter must also prepare an annual Periodical Risk-Benefit Analysis Report for the Cannabis Product and perform the post-marketing actions necessary for certain measures relating to their products.

In addition to the specific quality control, traceability, prescription and dispensation rules, pharmaceuticals rules on monitoring and inspection actions also apply to Cannabis Products.

[1] ANVISA’s Resolutions No. 24 of 14 June 2011 or Resolution No. 200 of 26 December 2017.

[2] CBD, plant cannabinoid of chemical name 2-[(1R,6R)-3-methyl-6-(1-methylethenyl)-2- cyclohexen-1-il]-5-penthyl-1,3-Benzenediol, CAS number 13956-29-1 and molecular formula C21H30O; and THC, plant cannabinoid of chemical name (6AR,10aR)-6,6,9-Trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-benzo[c]chromen-1-ol, CAS number 1972-08-3 and molecular formula C21H30O20.