Anvisa concludes public consultation on new regulation of Cannabis products

The period for submitting contributions to Public Consultation No. 1,316/2025, proposing changes to the Collegiate Board Resolution (RDC) 327/2019, which regulates Cannabis products for medicinal use in Brazil, ended this Monday (2).

The online form was available for 60 days and received over 7,000 submissions. However, the number may be inflated as some forms may have been opened without the completion of the actual submission of suggestions.

Proposals under discussion include prescription by dentists and new routes of administration

Among the main points of the proposal are the expansion of product administration routes - currently restricted to oral and nasal/inhalation forms - to also include dermatological, sublingual, and buccal routes.

Another highlight is the authorization for dentists to also prescribe the products. Currently, prescription is restricted only to doctors.

The proposal also suggests changes in the necessary prescription. Products with up to 0.2% THC can be prescribed with a white prescription, while those exceeding this concentration will continue to require a type “A” prescription, exclusively for patients with severe or debilitating diseases.

Manipulation and renewal of sanitary authorization

The preliminary consultation text also foresees the possibility of manipulation of products based on purified cannabidiol (CBD) in pharmacies, as well as extending the sanitary authorization period from five to up to ten years, subject to ongoing clinical study verification.

The proposal reaffirms that Cannabis products are not medicines but a transitional category created to meet a growing demand. Complete regularization as a medicine depends on the presentation of robust scientific evidence.

Next steps

With the end of the public consultation period, Anvisa is expected to compile and analyze the contributions received. The expectation is that the gathered information will help adjust the final text of the proposal, which will still be submitted for deliberation by the Collegiate Board of the Agency.

The revision of RDC 327/2019 does not change the rules of RDC 660/2022, which deals with exceptional importation by individuals, nor is it related to the decision of the Superior Court of Justice (STJ) regarding Cannabis cultivation in the country.

Podcast 

In the debut episode of Deusa Cast, an original podcast by Sechat, experts discussed the paths to the regulation of medicinal cannabis in Brazil. During the conversation with Navarro and Margarete Akemi, important suggestions were made for the revision of RDC 327, the regulation that governs cannabis-based products in the country and is expected to undergo updates in 2024.