Proposal to restrict Cannabis importation (RDC 660) sparks reaction in the market

The National Health Surveillance Agency (Anvisa) postponed, this Wednesday (10), the vote that would define the new guidelines for the regulation of Cannabis products in Brazil. The proposal presented suggests a significant change in access through importation by individuals, currently governed by RDC 660/2022. Sechat spoke with experts and import companies representatives to understand the market's perspective.

The review of Resolution RDC 327/2019, discussed during the Collegiate Board meeting (Dicol), had its progress interrupted after a request for a view by director Thiago Campos. According to the draft presented, the authorization for importation would be conditioned to the absence of equivalent items in the national market.

Agency data reveals the historical series of import authorizations for cannabis products with a sharp and uninterrupted growth from 2015 to 2024. The total authorizations granted jumped from 850 in 2015 to 167,337 in 2024, resulting in an exponential growth of 19,857%.

The total accumulated import authorizations by individuals, according to RDC 660 - and predecessors -, exceeded 458,438 over the decade.

According to Anvisa data, updated in early September 2025, patients who opt for importation currently have about 600 cannabis product options. This significant offer is supported by a market that already gathers more than 500 companies and a wide range of prices and competition.

Technical equivalence in products and impact on the patient

The technical change focuses on the similarity criterion between the imported item and the national one. The rule does not prohibit the importation of all Cannabis products, but it prohibits the entry of those that already have identical competitors in basic specifications regulated by the agency.

Priscila Gava Mazzola, a professor at Unicamp and columnist for Portal Sechat, explains that the measure aims to equate the plant to other categories of medications. Exceptional importation, in this context, would be a resource only when there is no local alternative.

“The change proposed by Anvisa does not prohibit the importation of isolated CBD, but restricts this access when there is, in Brazil, an equivalent product in pharmaceutical form and concentration,” details Mazzola. According to her, the regulatory intention is to reduce redundant imports and increase sanitary control, although it requires the prescriber to justify the absence of a national alternative.

Thaise Alvarez, CEO of Alma Lab, believes that reducing the comparison only to cannabinoid concentration may overlook fundamental biochemical characteristics. She mentions the entourage effect, which is the interaction between different plant compounds, as essential for therapeutic success.

“Treating extracts as generics disregards exactly what makes Cannabis such a personalized and responsive medication in multiple clinical conditions,” argues Alvarez. She believes that involuntary brand switching can destabilize the patient, distancing the proposal from clinical reality and the science of extracts.

Christiani Di Risio, CEO of Erth Wellness, emphasizes that the priority should be the stability of those already using Cannabis products. “We advocate that any regulatory review consider, above all, the patient's protection and the maintenance of access to items that have already demonstrated individual effectiveness,” she points out.

“The central point here is the patient. Every regulatory discussion needs to prioritize care, treatment continuity, and access assurance,” Di Risio concludes.

Costs and access to Cannabis products in the national market

Renata Paioleti, marketing manager at Golden Drops CBD, points out the price disparity as a barrier to the mandatory transition to national Cannabis products.

The draft establishes that most of the new rules of RDC 327 would come into effect in 90 days. The specific import restriction would have a 12-month adaptation period. “Even with the transition period, it must be recognized that the direct import substitution for products available in pharmacies may represent a significant cost increase for the patient,” says Paioleti.

For Renata, the decision could create an "artificial market reserve". This would harm companies that assist patients and facilitate safe access. "Today, a large part of patients using Medicinal Cannabis in Brazil depends exclusively on importation, not only for price but for formulation and therapeutic adequacy. Equivalence cannot be evaluated solely by the existence of a product on the shelf," she concludes.

Judicialization of access to Cannabis products and legal scenario

The proposed restriction raises the possibility of an increase in the number of legal proceedings to ensure access to specific brands. Pedro Gabriel Lopes, legal director of Instituto Fícus, believes that the forced interruption of treatments creates legal uncertainty.

“I believe there is indeed a chance of legal action precisely because of this, to continue treatment. With a change, there may be some risk,” analyzes the lawyer who attended the Dicol meeting.

Lopes also highlights that the inclusion of restrictions in RDC 660's final text occurred without broad prior discussion with civil society. “The text that was included in RDC 660, as presented, was not discussed with society. This is a point that raises significant concern,” he concludes.

Ricardo Parra Silva, CEO and founder of Gotta Pharma, also expresses concern about the lack of clarity in the proposal, especially regarding concentrations. “Will the evaluation be based on the extract or cannabinoid concentration? This raises a new question, as there are full-spectrum oils with 50%, others with 5% CBD, among other variations.”

Sanitary safety of imported Cannabis products

In addition to market issues, the debate has brought to light a structural point of the current importation standard. Pedro Gabriel Lopes believes that, from a public health perspective, the rapporteur's concern to establish quality filters is legally grounded.

"What needs to be said is that the products that enter through 660 have no quality control or confirmation of their safety," ponders the lawyer. He believes that Anvisa is trying to overcome this regulatory gap for items that could be authorized through traditional sanitary means.

However, the importation market has reacted with self-regulation. Many players adhere to quality standards and pharmaceutical industry rigor, providing the Certificate of Analysis (CoA) to ensure product safety and composition. Additionally, many companies already opt for certification in independent laboratories accredited by REDE REBLAS.

Pharmacist Priscila Gava Mazzola recalls that the review aims to reduce the asymmetry between national manufacturers, who comply with rigorous requirements, and direct importers.

Lopes warns that the solution should not only be a prohibition based on the existence of similarities. Clear quality criteria for Cannabis products entering the country are necessary. "It is up to Anvisa to establish these criteria, always thinking about patient safety," concludes the legal director.