Anvisa suspends review of RDC 327 after director's request for further analysis
Rapporteur Rômison Mota advocated for changes impacting imports via RDC 660; new rule prioritizes national products when there is equivalence
Published on 12/10/2025
Rapporteur director Rômison Rodrigues Mota. Image: Reproduction YouTube
The National Health Surveillance Agency (Anvisa) scheduled, this Wednesday (10), changes to the regulation that governs Cannabis products in Brazilian pharmacies. However, the review of RDC 327 had its voting suspended after an intervention by the board.
During the Collegiate Board meeting (Dicol), rapporteur director Rômison Rodrigues Mota presented his favorable opinion on the draft. However, after the reading of the vote, director Thiago Campos requested further analysis, halting the process. The deadline for the request for further analysis, on a matter under deliberative review, is 30 calendar days.
Proposals for importation and RDC 660
According to the presented text, the review of RDC 327 aims to establish updated requirements for the Sanitary Authorization (AS). The focus covers the manufacturing, importation, and commercialization of industrialized pharmaceutical products with cannabidiol (CBD) or Cannabis sativa L. extracts.
The draft suggests a restrictive modification in Article 3 of RDC no. 660/2022. The new paragraph conditions the importation by individuals on the absence of equivalent products in the national market. If there is an item with the same pharmaceutical form and concentration in pharmacies, the patient will not be able to import via RDC 660.
"I propose that the importation provided for in RDC 660 of 2022 be allowed only when there is no product in the same pharmaceutical form and concentration regulated in the country, in order to prevent patients from being underserved," said Rômison Mota.
The draft establishes different deadlines for the implementation of the new rules. Most of the review of RDC 327 will come into effect in 90 days. However, the restriction on importation via RDC 660 will only take effect 12 months after publication.
This extended period aims to provide a safe transition for patients and the market. The goal is to ensure adaptation before the priority of supply by national commerce becomes mandatory.
Composition and THC restrictions
Regarding composition, the review of RDC 327 maintains that products use CBD phytomedicine or extracts predominantly CBD. The presence of THC above 0.2% remains allowed only for palliative care in irreversible situations, being contraindicated for individuals under 18 years old.
The rapporteur emphasized the necessary caution with formulations rich in THC. "Based on the precautionary principle and risk mitigation, products of Cannabis [...] should not be constituted of phytomedicine with THC alone or in association with extracts of the THC-dominant chemotype," explained Mota.
The authorized administration routes remain restricted to oral, buccal, sublingual, inhalation, and dermatological forms. The rule prohibits cosmetics, food, smoking products, and the sale of the plant in natura.
Labeling and quality control
From a regulatory perspective, the product receives a Sanitary Authorization valid for five years. Labels must contain a warning that the item is not a conventional medicine but follows strict controls. Packaging with THC above 0.2% will have a black stripe, while others will have a red stripe.
The review of RDC 327 reiterates that sales occur exclusively in pharmacies, with a prescription retention requirement. Additionally, the rule demands quality controls on national soil for all batches, including imported ones.
Finally, the rapporteur emphasized that this process does not cover Cannabis cultivation in Brazil. The cultivation topic remains under the responsibility of director Thiago Campos, with a final deadline set for March 2026. Manipulation by magistral pharmacies was also not included in the vote.