The turning point for the regulation on Cannabis products

ANVISA opens public consultation at a timely moment for the development of the sector

On March 27, 2025, the Brazilian Health Regulatory Agency (ANVISA) published  Public Consultation No. 1316/25 (CP 1316), proposing a review of Collegiate Board Resolution (RDC) No. 327/19, which establishes procedures for granting health permits (AS) to produce and import cannabis products for medicinal purposes, as well as sale, prescription, dispensing, monitoring and inspection requirements.

Interested parties can contribute to the public consultation by June 02, 2025 through ANVISA’s website.

RDC No. 327/19 was published as a temporary alternative to legitimize Cannabis products given the Brazilian market’s increasing demand for such items. In this regard, the resolution established the health permit as a unique, simplified, and temporary procedure and provided for the permit holder’s obligation to submit the marketing authorization request within five years counted from the date when the permit was issued. This deadline cannot be extended.

According to ANVISA, the RDC guidelines were transitional and should have been reviewed within three years of its publication. However, such term was not sufficient for the development of the sector. As a result, after five years, this regulatory update is essential to ensure patients’ access to these products and a balanced risk-benefit relationship.

What is the current landscape?

Despite the therapeutic potential of Cannabis products, the medicinal cannabis sector in Brazil remains underdeveloped. According to ANVISA’s database, only one product containing tetrahydrocannabinol (THC) and cannabidiol (CBD) is registered as a medicine; and only one CBD clinical trial is currently in progress.

The main challenge of the industry is conducting clinical trials to produce scientific evidence of successful treatment with Cannabis products for multiple health conditions. Another obstacle is the lack of an official list of diagnostic conditions eligible for prescription of these products. Currently, the prescribing physician is responsible for justifying the use of these products by the adequate patients.¹

Currently, 37 products have temporary permits from ANVISA, and 45% of these permits should expire within the next three years. This highlights the importance of updating RDC No. 327/19 so that these permits can be renewed, ensuring patient access to essential treatments.

What are the main changes proposed in CP 1316?

• Permit extension

The possibility of extending the health permit for five additional years, only once, which also applies to companies with effective permits. 

• Additional routes of administration

The inclusion of new authorized routes of administration, in addition to oral and nasal: Buccal, sublingual, inhalational or dermatological. These products cannot be of modified release, nanotechnological, or PEGylated.

• Warnings

Exclusion of warnings that (i) the product may cause physical or psychic dependence, and (ii) there are uncertainties regarding long-term safety as a medicinal therapy. The warnings included were:

• • III – “Cannabis-based product;”
  • VII – “Attention: This product is not a medicine and there are uncertainties regarding safety; unpredictable or unknown adverse events may occur. In this case, notify adverse events through the VigiMed system, available on ANVISA’s website.;”
  • XII- “This product contains substance(s) that are prohibited in sports competitions.;”
  • XIII- For products that exceed 0.2% THC concentration: “This product is contraindicated for children under 18 years old, and pregnant and lactating individuals.”;
  • XIV- For products that exceed 0.2% THC concentration: “The use of this product by the elderly and patients with a history of Cannabis sativa L. dependence or who make non-medicinal use of it should occur at the discretion of the prescriber and only when the benefits outweigh potential risks.;”
  • XV- For products that exceed 0.2% THC concentration: “The use of this product may cause physical or psychic dependence.”; and
  • For products containing ethanol: “This product contains ___% ethanol and its use can bring risks, especially in children, and should only occur when the benefits outweigh potential risks, as assessed by the prescribing professional. The quantities of ethanol administered to these patients should be considered when defining the product’s dosage scheme in order to prevent toxicity.” º
  • The warning provided for by Normative Instruction 200/22 also apply, replacing the term “medicine” with “product” or “Cannabis product”, as the case may be.

• Publicity and advertising

A notable change in relation to RDC 327/19 is the possibility that companies may advertise their products to prescribing healthcare professionals, which is currently prohibited under any circumstances. The new resolution’s draft establishes this authorization provided that it complies with all regulations applicable to controlled medicines.

• Dental surgeons

Inclusion of dental surgeons among professionals qualified to prescribe Cannabis products, which only physicians can do currently.

• Dispensing of Cannabis products

CP 1316 recommends that Cannabis products be dispensed only by pharmacists in pharmacies or drugstores with the proper medical prescription. This differs from RDC No. 327/2019, which prohibited dispensing in compounding pharmacies.

• Import of Cannabis inputs and products

The proposal extends the health permit for the import of Cannabis inputs and products for the purposes of research, distribution, development, and manufacturing in Brazilian territory. This includes Cannabis sativa L. extract, CBD and industrialized bulk products. The distribution of these products will be allowed for establishments authorized to manufacture inputs or medicines, conduct teaching and research, or manipulate pharmaceutical inputs. However, compounding pharmacies will not be allowed to directly import CBD.

• Compounded medicines

Compounding pharmacies can produce products containing exclusively CBD with at least 98% purity on an anhydrous basis to simplify access to Cannabis products with controlled quality.

CP 1316 also addresses specific provisions on quality control, labeling, packaging and package inserts, packaging inviolability and traceability, health permit renewal request, and post-sale monitoring and inspection.

Import by a natural person for personal use

Despite not being the subject of CP 1316, ANVISA disclosed that it will start the review process of RDC No. 660/22, which provides for the import of Cannabis products by individuals for personal health treatment, based on a prescription from a legally-qualified professional.

Through vote No. 87/25, ANVISA informed that this import route represents the largest patient access channel to Cannabis products, contradicting the principle of RDC No. 660/22, which was to be an exception.

As such, the review seeks to mitigate health risks identified in imports based on RDC No. 660/22, such as the absence of health control for imported products not evaluated by ANVISA.

What about hemp?

ANVISA is also working to comply with the Superior Court of Justice’s (STJ) decision within the scope of Change of Jurisdiction Event (IAC) No. 16, which:

• Authorized the import, planting, cultivation, and sale of industrial hemp for medicinal and industrial pharmaceutical purposes; and
• Established that ANVISA and the Federal Government must enact a regulation within six months, that is, by May 19, 2025.

Despite similarities, this matter is not to be confused with the subject of CP 1316.

According to the STJ, hemp does not generate psychotropic effects and therefore is not prohibited by the Brazilian Anti-Drug Law (Law No. 11,343/06). The report developed by Instituto Ficus, in collaboration with the Brazilian Agricultural Research Corporation (EMBRAPA) –  a public research company linked to the Ministry of Agriculture and Livestock (MAPA) – , reveals that “estimates for the global industrial hemp market project its value at USD 5 billion to USD 7 billion, depending on the source, with a compound annual growth (CAGR) between 16% and 24.5% in 2023-2033”.

According to ANVISA’s Chief Prosecutor of the Federal Prosecutor’s Office, Fabrício Oliveira Braga, negotiations to regulate industrial hemp are being led by the Attorney General’s Office (AGU), which is mediating the Federal Government’s negotiations with the Ministry of Health, MAPA, and ANVISA.

Demarest’s Life Sciences and Healthcare team is available to provide any further clarifications that may be necessary.

[1] ANVISA. Regulatory Impact Analysis Report on Cannabis products for medicinal purposes [Relatório de Análise de Impacto Regulatório sobre Produtos de Cannabis para Fins Medicinais], p. 19 Brasília: ANVISA, 2025. Available at: https://anexosportal.datalegis.net/arquivos/1887753.pdf. Access on: March 28. 2025