Anvisa to resume voting on RDC 327 at the first meeting of 2026

The National Health Surveillance Agency (Anvisa) has scheduled the resumption of the vote on the revision of RDC 327 for next Wednesday, January 28, 2026. The standard, which regulates Cannabis products in Brazil, is item 2.5 on the agenda of the 1st Public Ordinary Meeting of the year. 

The meeting marks the return of director Thiago Lopes Cardoso Campos' point of view. The deliberation comes after the suspension of the process at the last meeting of 2025, held on December 10.

On that occasion, the rapporteur of the matter, director Rômison Rodrigues Mota, presented a favorable opinion on the new draft of RDC 327. However, the vote was interrupted by Campos' request for more time to analyze the technical text. 

Impacts of RDC 327 on imports

The central point of the discussion involves changes in the rules for importing products by individuals. The draft presented by the rapporteur proposes a restrictive amendment to RDC No. 660/2022, conditioning the entry of foreign products to their availability in the domestic market.

According to the proposed text, individual importation would only be allowed if there is no equivalent product available in Brazilian pharmacies regulated by RDC 327. Equivalence considers the same pharmaceutical form and concentration of cannabinoids.

According to the vote cast by Rômison Mota in December, the measure aims to strengthen the national market and health security. However, there is a provision for a transition period for patients and companies to adapt to the new requirements.

Christiani Di Risio, representative of Erth Wellness, believes that it is not the time for changes to RDC 660. "The resolution needs to be regularized autonomously, based on a Regulatory Impact Analysis (RIA)"

She believes that only then will it be possible to consider a revision of the standard with elements that "effectively meet the patient's interests, especially regarding access methods," says Christiani.

Social mobilization and defense of RDC 660

Facing the scenario of possible restrictions, the Institute for Connection and Regulation (ICR) intensified mobilization in the final stretch of a national petition. The initiative advocates for maintaining access to imported products according to the current rules of RDC 660/2022, arguing that the change could disrupt ongoing treatments.

The institute emphasizes that many imported medications are used for complex conditions — such as refractory epilepsies, chronic pain, Autism Spectrum Disorder (ASD), Parkinson's, and Alzheimer's — and often do not have therapeutic equivalents in the national market with the same formulation or pharmacological profile.

The document pleads for the continuation of established treatments, therapeutic freedom for doctors and patients, and legal certainty for companies operating within the law. According to the ICR, this moment is crucial to ensure the coexistence of different access models in the country.

Composition rules and restrictions

The revision maintains the prohibition of smoking products, cosmetics, food, and the sale of the plant in its natural form. The administration routes authorized by RDC 327 remain restricted to oral, buccal, sublingual, inhalation, and dermatological forms.

Regarding the concentration of Tetrahydrocannabinol (THC), the proposal continues to require caution. Products with a THC content above 0.2% would be exclusively for palliative care in irreversible situations, contraindicated for individuals under 18 years old.

Packaging for these more concentrated formulations would receive a black warning label. Meanwhile, other formulations with a THC content below 0.2% would maintain identification with a red label, following the current pharmaceutical standard.

Optimism in the compounding sector for the inclusion of pharmacies
Another highlight of the discussion is the possible inclusion of compounding pharmacies in the new resolution. Although the topic was not addressed in the initial vote by rapporteur Rômison Mota, the sector remains hopeful of reversing the situation in the final vote.

The National Association of Compounding Pharmacists (Anfarmag) argues that the exclusion lacks a technical basis. Marco Fiaschetti, executive director of the entity, discussed the topic in an interview on the Deusa Cast - Sechat Podcast, airing this Tuesday (27) at 8 p.m. According to the executive, "the optimism comes from the understanding that society loses when compounding pharmacies cannot serve this portion of the population".

Fiaschetti emphasizes that the sector already deals with highly controlled substances, making the compounding of Cannabis a safe and viable process. "In Anfarmag's view, the current prohibition is unwarranted. There is no technical or ethical justification for a pharmacy not being able to work with these products, especially since it deals with much more dangerous products, such as opium derivatives and hormones," he argued.

The executive director of Anfarmag also points out that there are no operational barriers to this inclusion. "There is no technical complexity in Cannabis-based preparations that justifies keeping compounding pharmacies out," Fiaschetti stated, describing the current prohibition as contradictory: "We strongly believe that this will be reviewed. It would be a major inconsistency, in such a review, for compounding pharmacies to remain outside this market".

Sector expectations regarding the new RDC 327

The meeting is scheduled for 9:30 a.m. at Anvisa's headquarters in Brasília. For experts following the regulation, the return of the topic to the agenda follows the expected procedure, but the final result depends on the input from director Thiago Campos and other members of the Board.

Lawyer Diogo Busse analyzes the scenario cautiously, despite seeing advances in consolidating the regulatory text. He highlights that the process could still face procedural interruptions.

"We cannot guarantee progress without another request for review. Nevertheless, I believe that we are very close to the new draft of the new RDC," Busse evaluates.