A new cannabis-based product was authorized by Anvisa on May 2021 for medicinal use. With so many recent news, it is common for physicians to get confused about what can be produced and traded in Brazil.
To clarify how authorizations work and what is currently in effect, we produced this article to facilitate the physician’s understanding. Understand the current legal situation in our country and the profile of import approvals for cannabis-based products through the Brazilian Health Surveillance Agency (Anvisa).
Cannabis and Anvisa: What is allowed in Brazil?
On May 2021, Anvisa published another health authorization for a cannabis-based product, Cannabidiol Farmanguinhos 200 mg/ml. Based on this decision, research for the development of the product is authorized.
Manufactured in Brazil by the company Prati Donaduzzi and distributed by Fundação Oswaldo Cruz (Fiocruz), the product will not be sold in drugstores, but made available to the Brazilian Unified Health System (SUS). This is because Fiocruz does not sell its products; it only supplies the Ministry of Health and public agencies.
Cannabidiol Farmanguinhos is an oral solution, with 200 mg/mL of isolated CBD. Its indication will be the responsibility of the physician, which reinforces the need for specialized training in the field.
>>> For further information on this product profile compared to other cannabis-based formulations, read the blog post Learn about the medicinal attributes of the THC and its therapeutic properties. And learn more about Cannabis Quemovariants and the Entourage Effects that occurs when using the complete plant extract.
We produce highly qualified technical content on the clinical applications and therapeutic results of the main phyto-cannabinoids and terpenes present in the plant.
Read on and understand how the regulatory procedure of medicinal cannabis in our country has evolved.
Evolution of the regulatory process of medical cannabis in Brazil
The production and sale of these products in pharmacies and drugstores were approved by ANVISA at the end of 2019 through the Resolution of the Collegiate Board of Directors (RDC 327/2019) (RDC 327/2019).
The following year, in March 2020, the manufacture, importation, and marketing of medicinal cannabis-based products were officially regulated. Since then, sales in pharmacies, other than compounding pharmacies, were allowed.
Anvisa made clear in the resolution which types of authorizations are granted in Brazil. Products with THC, regardless of content, are authorized for oral administration.
Companies interested in producing or commercializing Cannabis-based products for medicinal purposes need to request authorization from the agency The conditions of the applicants are evaluated before they can receive the health authority’s approval to operate in this area. Following this, commercialization is released.
It is important to note that it is not a registration because it is a product, not a medicine. Let us understand this better below.
Difference between cannabis-based product and medicine
Anvisa considers Cannabis-based products as a specific category. The March 2020 resolution differentiated between Cannabis products and Cannabis-based medicines. These differences are:
|Require registration||Only require health authorization|
|Requires Anvisa’s prior analysis||Does not require Anvisa’s prior analysis|
|Registration is valid for ten years||Health authorization is valid for 5 years|
|Registration is renewable||Authorization is not renewable|
|May have commercial names||Cannot have a commercial name (only of the plant derivative or phytomedicines, together with the name of the company responsible)|
|The route of administration, in accordance with the safety and efficacy data submitted to the registry. You can come up with different routes of administration: oral, topical, nasal, rectal, etc.||The route of administration is enabled: only the mouth or nose|
|Follows RDC 47/2009 and RDC 71/2009||Restrictions and obligations should appear on the label, packaging, and package insert|
|Patients (or their representatives) must sign an informed consent form|
While presenting these differences, Anvisa considers the similarities in the product and cannabis-based medicine.
- Standards related to monitoring and inspection of medicines apply.
- Quality control requirements follow the resolutions that provide for specific drugsRDC 24/2011 or RDC 26/2014);
- The responsible company must have proper authorizations (operating-AFE-and special-AE) and a certificate of good manufacturing practices for medicines (CBPF).
- Dispensing must follow the specific prescription.
- The documentation movement must be recorded in the national management system of controlled products (SNGPC).
The use of cannabis-based medicines has been authorized by Anvisa since 2016. However, each case is evaluated individually. In addition, these drugs need to be imported after authorization because they are not manufactured in Brazil.
Quanto aos produtos de Cannabis, só estão autorizados aqueles desenvolvidos para aplicação em via oral ou nasal. Substâncias administradas via inalada não estão inclusas na resolução.
>> Confira o nosso guia para escolha de medicamentos à base de Cannabis, disponibilizado em formato de e-book.
First cannabis products authorized in Brazil
Manufactured by GW Pharmaceuticals and launched in 2005 in Canada, Sativex® was the first medicine made from Cannabis and approved by regulatory agencies in the world.
Twelve years later, the drug arrived in Brazil. It was the first cannabis-based medicine to have its registration approved by Anvisa, under the name Mevatyl®, in 2017.
Its pharmaceutical form is an oral and oropharyngeal spray. The product contains similar proportions of tetrahydrocannabinol (THC) and cannabidiol (CBD). It is registered to treat symptoms of muscle stiffness and spasticity conditions, related to multiple sclerosis. However, the formulation is also effective in treating spasticity resulting from other neurological injuries such as stroke and traumatic brain or spinal cord injury.
On April 2020, Anvisa authorized a phyto-pharmaceutical product, manufactured by the company Prati Donaduzzi. Cannabidiol 200 mg/ml, 30 ml, is available in some Brazilian drugstores.
Unlike Mevatyl®, the isolated Prati Donaduzzi cannabidiol has not yet been registered and therefore does not have a specific indication. This means that it can be prescribed at the physician's discretion, in any context that the substance may be beneficial to the patient.
More cannabis-based product companies have already signaled that they have the necessary documentation to register their products with ANVISA in the coming months. This indicates the availability of more cannabis-based medicine options in the market, and most likely, at a lower cost.
What is in progress about medicinal cannabis at Anvisa
Bill 399/2015, which is considered the great regulatory framework for cannabis in Brazil, is in progress at the National Congress.
The text deals with the medicinal use of the plant, suggesting the marketing of medicines that have cannabis derivatives in their formulas. Moreover, it foresees its industrial use as a raw material in the manufacture of fabrics, plastic, paper, among other products.
Another point addressed by this bill is the medicinal use of cannabis to treat animals.
Want to dig deeper to include medical cannabis in your practice? Contact us and find out how to join our exclusive study community!
Anvisa publica Autorização Sanitária de produto à base de Cannabis solicitada pela Fiocruz https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2021/anvisa-publica-autorizacao-sanitaria-de-produto-a-base-de-cannabis-solicitada-pela-fiocruz
Anvisa approves commercialization of the first cannabis-based product
Anvisa approves patent for cannabis-based chewing gum to treat chronic pain
Evidências mostram potencial da Cannabis contra doenças (Fiocruz)
Manufacturing and sale of cannabis products goes into effect
RESOLUTION OF THE COLLEGIATE BOARD OF DIRECTORS - RDC 327, DECEMBER 9, 2019