{"id":1555,"date":"2022-06-10T15:54:53","date_gmt":"2022-06-10T18:54:53","guid":{"rendered":"https:\/\/new-website.wecann.academy\/2022\/06\/10\/cannabis-and-anvisa-what-is-and-what-is-not-allowed-in-brazil\/"},"modified":"2025-10-19T23:31:09","modified_gmt":"2025-10-20T02:31:09","slug":"cannabis-and-anvisa-what-is-and-what-is-not-allowed-in-brazil","status":"publish","type":"post","link":"https:\/\/wecann.academy\/en\/cannabis-and-anvisa-what-is-and-what-is-not-allowed-in-brazil\/","title":{"rendered":"Cannabis and Anvisa: what is and what is not allowed in Brazil?"},"content":{"rendered":"

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A new cannabis-based product was authorized by Anvisa<\/span><\/span><\/a> 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.<\/span><\/span><\/p>\n

To clarify how authorizations work and what is currently in effect, we produced this article to facilitate the physician\u2019s 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).<\/p>\n

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Cannabis and Anvisa: What is allowed in Brazil?<\/h2>\n

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.\u00a0<\/p>\n

Manufactured in Brazil by the company Prati Donaduzzi and distributed by Funda\u00e7\u00e3o 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.\u00a0<\/p>\n

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<\/span><\/span><\/a>.<\/span><\/span><\/p>\n

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>>> 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<\/span><\/span><\/a>. And learn more about Cannabis Quemovariants<\/strong><\/span><\/span><\/a> and the Entourage Effects that occurs when using the complete plant extract.<\/strong><\/span><\/p>\n

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We produce highly qualified technical content on the clinical applications and therapeutic results of the main phyto-cannabinoids and terpenes present in the plant.<\/p>\n

Read on and understand how the regulatory procedure of medicinal cannabis in our country has evolved.<\/p>\n

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Evolution of the regulatory process of medical cannabis in Brazil<\/h2>\n

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)<\/u><\/a> (RDC 327\/2019).<\/p>\n

The following year, in March 2020, the manufacture, importation, and marketing of medicinal cannabis-based products were officially regulated<\/u><\/a>. Since then, sales in pharmacies, other than compounding pharmacies, were allowed.<\/p>\n

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Learn more about the endocannabinoid system and why you should understand it to treat your patients.<\/span><\/span><\/a><\/strong>.<\/p>\n

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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.<\/strong><\/p>\n

Companies interested in producing or commercializing Cannabis-based products for medicinal purposes need to request authorization from the agency<\/u><\/a> The conditions of the applicants are evaluated before they can receive the health authority\u2019s approval to operate in this area. Following this, commercialization is released.<\/p>\n

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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.<\/p>\n

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Difference between cannabis-based product and medicine<\/h2>\n

Anvisa considers Cannabis-based products as a specific category. The March 2020 resolution differentiated between Cannabis products and Cannabis-based medicines. These differences are:<\/p>\n

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Cannabis-based Medicines<\/strong><\/p>\n<\/td>\n

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Cannabis-based products<\/strong><\/p>\n<\/td>\n<\/tr>\n

Require registration<\/td>\nOnly require health authorization<\/td>\n<\/tr>\n
Requires Anvisa\u2019s prior analysis<\/td>\nDoes not require Anvisa\u2019s prior analysis<\/td>\n<\/tr>\n
Registration is valid for ten years<\/td>\nHealth authorization is valid for 5 years<\/td>\n<\/tr>\n
Registration is renewable<\/td>\nAuthorization is not renewable<\/td>\n<\/tr>\n
May have commercial names<\/td>\nCannot have a commercial name (only of the plant derivative or phytomedicines, together with the name of the company responsible)<\/td>\n<\/tr>\n
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.<\/td>\nThe route of administration is enabled: only the mouth or nose<\/td>\n<\/tr>\n
Follows <\/span><\/span>RDC 47\/2009<\/span><\/span><\/a> and <\/span><\/span>RDC 71\/2009<\/span><\/span><\/a><\/span><\/td>\nRestrictions and obligations should appear on the label, packaging, and package insert<\/td>\n<\/tr>\n
<\/td>\nPatients (or their representatives) must sign an informed consent form<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Source: <\/span><\/span>Anvisa<\/span><\/span><\/a><\/span><\/p>\n

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While presenting these differences, Anvisa considers the similarities in the product and cannabis-based medicine.<\/p>\n