FREQUENTLY ASKED QUESTIONS
What is Cannabis or Cannabis Sativa?
Cannabis (name in English) or Cannabis Sativa (scientific name) is a plant that includes three different varieties*: Cannabis Sativa, Cannabis Sativa Indica and Cannabis Sativa Ruderalis, native to Central and South Asia. The plant has been widely used for the manufacture of fibers, for seeds and seed oils, for medicinal purposes and as a psychoactive drug. To comply with the UN Narcotics Convention, some strains of cannabis were created to produce minimal levels of THC, one of the main substances in Cannabis and the one responsible for the psychoactive effect associated with the plant. These high CBD and low THC strains are widely used in the medical and industrial (hemp) fields.
Cannabis has an antiemetic effect and can be used to relieve cancer-related nausea and depression. It can also be used as a pain reliever. Some studies show that it is capable of significantly reducing intraocular pressure and tear flow in patients with glaucoma, although the effect is short-lived. CBD has a potential seizure inhibitor in animals and humans and can help in the treatment of spasticity and neuropathic pain that can accompany multiple sclerosis and also in the treatment of two forms of severe epilepsy in childhood, Dravet's syndrome and Lennox Gasas syndrome.
Industrial hemp products are made from selected Cannabis plants to produce a large amount of fiber. Currently, it is known that the use of hemp in the production of industrialized products in general is an emerging ecological alternative. Many companies are looking for greener and less polluting products, finding in Cannabis an important tool for changing the landscape. According to a study carried out by the paper industry, they were able to prove that in the same area and in the same period of time, it is possible to produce up to 3 times more Cannabis paper than in the area of tree paper production. There is also knowledge of baby diaper industries, which would like to produce more environmentally friendly diapers in Brazil, but the industry sector is prevented from such an ecological attitude due to the laws against hemp planting in Brazil.
Despite the history of prohibitions, more than 263 million people use Cannabis worldwide. The total global Cannabis market (regulated and illicit) is estimated at USD $ 344 billion. In 2018 alone, the global regulated market for Cannabis and derivatives generated around US$ 18 billion and Euromonitor estimates that by 2025 this niche will generate more than US$ 166 billion, since there are about 1.2 billion people suffering from diseases that can benefit from the therapeutic potential of Cannabis worldwide.
* Part of the Cannabis bibliography defends the existence of only one species of the plant and that the physical differences between one plant unit and another occur due to the environmental conditions of cultivation in each region, over time.
What are cannabinoids?
Cannabinoids are active compounds that interact with receptors throughout the body. There are about 113 different cannabinoids already discovered. Scientists are still learning about the behaviors and effects of each cannabinoid, and how they interact with the human body. Cannabinoids are the chemical components found in Cannabis Sativa, most of which are concentrated within the plant's trichomes. CBD and THC are the best known cannabinoids. CBD being the most recommended for medical use, and THC responsible for psychoactive effects and indicated in specific medical treatments. New research still indicates that cannabinoids are subgroups of terpenes, with broad activity with therapeutic effects. Terpenes are chemical components that give a unique signature to essences, flavors and drive the effects of major cannabinoids. CBD stands for cannabidiol, the most prominent naturally occurring cannabinoid component found in hemp. According to the United States government, cannabidiol is "a cannabinoid with no psychoactive effect". After THC (D9-tetrahydrocannabinol), CBD is by far the most studied natural cannabinoid. According to many researchers, CBD may be the most important cannabinoid ever discovered, and this important hemp plant compound promotes and supports the nutritional health of aging bodies. Source: US Patent # 6,630,507
THC or D9-tetrahydrocannabinol is generated through decarboxylation, a chemical process that isolates the carboxylic group from the THCA molecule and releases carbon dioxide. When the carboxylic group is removed, it is replaced by a proton, which changes its characteristic abruptly, making the substance psychoactive.
What is the endocannabinoid system?
Natural system in our brain and body. It is a system that is present in all animals and fish, and evolutionarily goes back 600 million years. The job of the endocannabinoid system is to modulate other systems in the body that can become overheated. It is like a braking system, which can slow down a wide variety of systems in the body, including pain perception, gastrointestinal motility, memory, sleep, stress response, pain and appetite, to name a few. The endocannabinoid system has unique functions throughout the body, but especially in the brain and the immune system. In fact, receptors in the endocannabinoid system are the most common receptors in the brain and the second most common receptor in the body, showing exactly how important the endocannabinoid system is.
What national laws govern the Cannabis byproducts industry in Brazil?
In Brazil, medical Cannabis begins to be released in 2014 when Anvisa (National Health Surveillance Agency) authorizes the import process on a case-by-case basis of finished Cannabis-based products, for medical purposes, upon request from the patient and with a prescription of a health care professional. Today, this process occurs via RDC - Collegiate Board Resolution N. 660/2022.
In 2019 the agency starts the commercial era of medicinal Cannabis in Brazil, regulating the national manufacture of Cannabis byproducts with imported raw material (RDC - Collegiate Board Resolution N. 327/2019), for both CBD and THC and other cannabinoids. The cultivation of raw materials for commercial purposes remains prohibited, so Brazilian pharmaceutical companies that intend to offer these products must apply for a special authorization from Anvisa that enables them to purchase raw materials from abroad.
For the purpose of manufacturing and selling Cannabis products, in the national territory, the company must import the pharmaceutical Cannabis raw material in the forms of vegetable derivatives, phytopharmaceuticals, in bulk, or industrialized products. Imported Cannabis products must be properly regulated by the competent authorities in their countries of origin (GMP and GAP certificates) and the import process must follow the specifications of RDC No. 11/2013. Final products must be tested by analytical laboratories providing services that carry out quality control tests on batches of finished products. Only manufacturing companies that have a Certificate of Good Manufacturing Practices (CBPF) for medicines issued by Anvisa or importing companies that comply with the Good Distribution and Storage Practices for medication can apply for Sanitary Authorization and manufacture Cannabis products. Cannabis-based products are also subject to the regulation of herbal medicines or medications, according to RDC N. 26/2014 and RDC N. 24/2011.
The regulation foresees that distribution will be made exclusively by pharmacies, through a prescription of special control. Cannabis products distribution will be authorized for oral or nasal use only and any advertising of Cannabis products is prohibited.
What is the status of current international legislation on the marketing of Cannabis Sativa?
Today there are already more than 50 countries that have some kind of regulation that makes Cannabis and hemp legal at least for medical use, including Canada, United States (36 states), Mexico, Jamaica, Colombia, Ecuador, Peru, Uruguay, Chile, Israel, Thailand, Zambia, Lesotho, Australia, New Zealand, Germany, United Kingdom, Switzerland, Spain, Portugal, Norway, Denmark, Holland, Italy and Brazil.
The import transaction is subject to the international legislation of INCB - United Nations International Narcotics Control Board. In its 2014 Annual Report, INCB clearly recognized medical Cannabis programs and listed a number of criteria that must be respected for the implementation of such programs. In this way, national importers and manufacturers must work together with ANVISA to estimate national consumption and request coupons for trade authorization for Cannabis derivatives.
Among the countries that are prepared to cultivate Cannabis and transform the raw material for export to Brazil are: Canada, Jamaica, Colombia, Ecuador, Paraguay, Israel, Zambia, Lesotho, Australia, Denmark, England. All of these countries are capable of complying with INCB rules. Each foreign producer must have a certificate of good manufacturing practices (GMP) issued by a government agency. The countries with the most advanced legislation and procedures are England (largest exporter), Australia, Canada, Portugal, Israel and Colombia.
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What are Cannabis byproducts?
All processed products that have parts of the Cannabis Sativa plant in their composition, being possible to use leaf, root, stem, fiber, resin, seed, and isolated components thereof. Some examples are: extractions, medicines, plastic alloys, fabrics, fuel, processed foods, construction materials, paper, cosmetics and products for recreational and medical use, such as cigarettes, vaporizers, extractions (distilled resin, live resin, isolates, others).
What are Cannabis-based products regulated by ANVISA?
They are industrialized products containing Cannabis Sativa as plant derivatives or phytopharmaceuticals, regulated by ANVISA's health authorization.
What is the difference between herbal products and Cannabis-based phytopharmaceuticals?
According to RDC N. 26, of May 13, 2014 from ANVISA, herbal medicine or phytotherapics, it is considered the medicine obtained through vegetable raw materials. Herbal medicine is considered to be one that, in its composition, does not include isolated active substances of any origin, nor their associations with plant extracts.
Phytopharmaceuticals are also considered medicines of plant origin and differ from phytotherapics because they contain purified substances isolated from vegetable raw material with defined chemical structure and pharmacological activity. For example, CBD or morphine, when isolated and indicated for therapeutic purposes, are considered phytopharmaceuticals. They are used as active substances in medicines with prophylactic, palliative or curative properties. Phytopharmaceuticals are not considered to be isolated compounds that have undergone any stage of semi-synthesis or modification of their chemical structure.
How can my company participate in the cannabis byproducts market in Brazil?
Import raw materials, manufacture or distribute finished byproducts, having specialized clinics, import of equipment, assembly of laboratories, legal relations, accounting, publicity and specialized advertising (for registered medicines), engineering, among others.
What will not be allowed in the Brazilian medical cannabis market?
In the international distribution model, governed by RDC nº 660/2022, products for veterinary use, products without medical prescription, raw materials and flowers in natura cannot be sold.
In the national marketing model, according to RDC nº 327/2019 companies can only sell raw material or finished product to the national manufacturer, which in turn can only offer medicinal products for oral or nasal use to the final patient. Therefore, it is prohibited to trade fresh flowers, vaporizers, ointments, creams, cosmetics, perfumery, edibles/food, cigarettes, tobacco products and products for veterinary use under this model of commercialization.
I am a patient or person interested in trying a treatment with a Cannabis byproduct, how can I have access to Cannabis-based drugs or products?
Anvisa (National Health Surveillance Agency) can authorize the individual import of products derived from Cannabis for health treatments. It is necessary to have a prescription (prescription) from a legally qualified professional. The authorization allows individuals or their legal representatives to import the product for a period of two years. The criteria are in RDC nº 660/2022 which can be found on the Anvisa portal: https://www.gov.br/pt-br/servicos/solicitar-autorizacao-para-importacao-excepcional-de-produtos-a-base-de-canabidiol.
Import orders are received exclusively through the Federal Government's Services Portal and are normally analyzed within 10 business days, although this processing time can vary.
In December 2019, Anvisa also approved the creation of a new category of products derived from Cannabis. The approved Resolution came into force on March 10, 2020. As of this date, Cannabis-based products can be found in Brazilian pharmacies.
The regulation provides that the distribution of Cannabis products will be made exclusively through a prescription of special control by a health care professional. The rules vary according to the concentration of tetrahydrocannabinol (THC). In formulations with THC concentration up to 0.2%, the product must be prescribed using a type B prescription, with numbers provided by the local Health Agency and prescription renewal within 60 days. Products with THC concentrations greater than 0.2% can only be prescribed to terminal patients or those who have exhausted therapeutic treatment alternatives. In this case, the prescription form will be type A, valid for 30 days, provided by the local Health Agency, a standard similar to that of morphine, for example. In this way, the patient should talk to his trusted doctor to have access to the type B prescription for products based only on CBD (THC below 0.2%) or type A for products containing THC.
With the prescription in hand, the patient should go to a pharmacy and ask about the availability of these products. The products available can be for oral use, nasal application, tablets, liquids and oily solutions.
I am a healthcare professional and I want to better understand how Cannabis products work, what should I do?
Getting quality information about medical Cannabis can be a bit complicated by the novelty of the subject. However, there are already scientific materials, studies, analysis, books and documents on the effectiveness of Cannabis Sativa in numerous medical treatments. As a complementary reading on the effects of CBD on the human body, we recommend the book "CBD: All You Need To Know" by Dr. Gregory Smith M.d.
Who is Brazcann?
The company was founded after years of commercial study in countries such as Canada, United States, Mexico, UK, Brazil, Colombia, Argentina and European Union countries, making it possible to see more clearly how laws work and the opportunities created with the legalization of Cannabis medicine in Brazil. One of our main purposes is to reduce the cost of Cannabis raw materials in Brazil.
In December 2019, Anvisa published Collegiate Board Resolution No. 327/2019, which lists the necessary requirements for the regularization of Cannabis byproducts. Since the planting of the Cannabis plant remains prohibited, companies wishing to manufacture such products must import the raw material in extraction or final product format (the import of plants or parts thereof is not permitted).
In this context, Brazcann was born, a Brazilian company dedicated to understanding the market and industry of products derived from Cannabis and hemp, as well as the respective legislation, aiming to participate in the national interaction of Cannabis byproducts for medicinal purposes, providing consultancy services in the import of raw materials and production chain equipment for companies that wish to manufacture or import cannabis-derived products in Brazil, as well as consultancy for the registration, distribution and prescription of Cannabis-based products. In 2020, the company joined the FAE Business School acceleration program, FAE Incentiva (fae.edu) and received support to expand its operations in the Brazilian Cannabis market by 2022.
Today, Brazcann provides consultancy for the regularization and distribution of products, having already provided assistance to around 30 players in the medicinal Cannabis industry, such as suppliers of raw materials and final products, doctors and healthcare professionals, patients, pharmacy chains, pharmaceutical companies and representatives of international brands. Brazcann serves clients from different countries and specializes in international industry interaction, in addition to supporting the education of patients and families.
How can Brazcann help my organization?
Through personalized consulting in which we offer unique opportunities for entry or expansion of your company in the Brazilian Cannabis market, through Anvisa regulations for registered medicines, products without clinical trials or direct export to the patient.
Brazcann is able to support the studies, formulation, registration, import, manufacture, distribution, storage, transport, propagation and prescription of cannabinoids for:
- National importing or pharmaceutical companies,
- Brazilian pharmacies that distribute cannabis-based products
- Health professionals
- Laboratories
Check out our publications to access more sources and infos
All information in our FAQ is based on public data and serves for informational purposes only, and should not be used as is to support business decisions or research, as it does not replace the complete legislation that must be verified on the portal of ANVISA