Anvisa opened Public Consultation to update cannabis-based product regulations
On March 26th, 2025, Anvisa’s Board of Directors (“DICOL”) approved the opening of a Public Consultation (“PC”) to review the regulation of cannabis-based products. The PC was published on March 28th, and interested parties can submit contributions until June 6th, 2025.
What happened?
The proposal to revise RDC 327/2019 includes significant changes, such as allowing the commercialization of cannabis-based products in compounding pharmacies. Anvisa suggests allowing the compounding of products containing exclusively the phytopharmaceutical CBD, provided it has at least 98% purity in an anhydrous base.
What was proposed?
Key points of the proposed changes include:
Expansion of administration routes
The proposal expands the permitted routes of administration for cannabis-based products to include buccal, sublingual, inhalation, and dermatological routes, in addition to the already permitted oral and nasal routes. Injectable and sterile pharmaceutical forms remain excluded due to associated risks.
Authorization for prescription by dentists
The proposal allows dentists, in addition to doctors, to prescribe cannabis-based products for patients without satisfactory therapeutic alternatives with registered medicines in the country.
Compounding of magistral preparations
The proposal allows the compounding of magistral preparations containing exclusively the phytopharmaceutical CBD with at least 98% purity in an anhydrous base. This aims to facilitate access to quality-controlled cannabis products.
Importation of cannabis ingredients and products
The proposal authorizes the importation of cannabidiol and bulk industrialized products for research, development, and manufacturing of active pharmaceutical ingredients and medicines. Direct importation of the phytopharmaceutical CBD by compounding pharmacies remains prohibited.
Directed advertising
The proposal allows advertising of cannabis-based products, provided it is directed exclusively at prescribing professionals and based on information provided in the informational leaflet and labeling.
Validity of sanitary authorization
The sanitary authorization for cannabis-based products will be valid for five years, with the possibility of renewal for an equal period. Companies that have not yet applied for the product’s registration as a medicine may request the renewal of the sanitary authorization.
Technical requirements and quality control
The proposal establishes specific technical requirements for activities related to the importation, commercialization, prescription, dispensing, monitoring, and inspection of cannabis-based products, aiming to ensure the quality and safety of the products.
Why is this important?
In Brazil, products containing cannabis derivatives can be regulated in two distinct categories: as medicines, following the rules for proving quality, safety, and efficacy, or as cannabis-based products, with a simplified regularization process based on RDC 327/2019. Currently, there is only one approved cannabis medicine and 36 regulated cannabis-based products.
According to the current regulatory framework, the sanitary authorization for cannabis-based products has a non-renewable term of five years.
Therefore, the decision is significant, considering that the term of the first sanitary authorizations is ending.
The expectation is that Anvisa will publish a new regulatory framework for cannabis-based products later this year.
Comments from Anvisa’s Director-President
Romison Mota highlighted that the prohibition of dispensing industrialized cannabis-based products by compounding pharmacies is not technically justified.
Additionally, he clarified that the revision of RDC 327/2019 does not confuse with the recent decision issued by the Superior Court of Justice (“STJ”), which determined that Anvisa must create rules for the cultivation, industrialization, and commercialization of hemp by May 19.
RDC 660/2020
During the meeting, fifteen cannabis-based product importers, through the Institute for Connection and Regulation (ICR), presented a proposal to Anvisa to prevent what they call a market reserve for national manufacturers.
Previously, the Pharmaceutical Products Industry Association (Sindusfarma) defended the prevalence of RDC 327/2019, which regulates the manufacturing and commercialization of cannabis-based products in Brazil, arguing that this resolution guarantees the quality, safety, and efficacy of the products.
Sindusfarma argues that RDC 660/2020 – which deals with the exceptional importation by individuals for personal use – was created in an exceptional context and does not meet the safety criteria established by Anvisa. The entity suggests the revocation of RDC 660/2020, stating that the emergency situation that justified its creation has already been overcome.
Director Daniel Pereira also highlighted the need to review RDC 660/2020 to align with the current regulatory and market scenario.
What are the next steps?
DICOL unanimously decided to approve:
• Public Consultation for 60 days, starting on April 7th, 2025, and ending on June 6th, 2025.
• Proposal to review RDC 660/2022 through the opening of an administrative regulation process, with deadlines to be presented at the next DICOL meeting.
Industries, compounding pharmacies, medical entities, patient associations, and civil society will have 60 days to submit their contributions to Anvisa – from April 7th to June 6th.
Our Life Sciences & Healthcare team at Souto Correa is available for any questions about these topics and their possible developments through the email: lifesciences@soutocorrea.com.br.