Voting on RDC 327 is postponed at Anvisa; ABIQUIFI evaluates new deadline as "legitimate instrument"

The National Health Surveillance Agency (Anvisa) postponed, on Wednesday (10), the vote on the proposal to revise Collegiate Board Resolution (RDC) No. 327/2019, which establishes the rules for the commercialization of cannabis products in the country. The process, which will define important guidelines for the market, was halted after director Thiago Campos made a request for a view.

The decision postpones the Collegiate Board (Dicol) deliberation for up to 30 calendar days, projecting the conclusion of the topic for January 2026. The reporting director, Rômison Rodrigues Mota, had presented his favorable vote on the draft, detailing the proposed changes.

Process and Regulatory Framework

The Brazilian Association of Pharmaceutical Inputs Industry (ABIQUIFI) expressed its views on the suspension, reinforcing its confidence in Anvisa's work and the legitimacy of the regulatory instrument used.

In an official statement, ABIQUIFI minimized the impact of the postponement, viewing the request for a view as an opportunity for technical improvement.

"ABIQUIFI confidently follows the review process of RDC 327/2019, essential for the regulated development of medicinal cannabis products in Brazil. The request for views presented by Director Thiago Campos adds a few weeks to the schedule, but it is a legitimate instrument and allows for a more in-depth analysis of relevant points for the regulator and the sector," stated the Association.

ABIQUIFI's positioning signals the sector's interest in a solid and secure regulatory framework, reiterating its willingness to collaborate with the Agency. "We maintain the expectation that the review will be concluded soon and reiterate our willingness to contribute with technical subsidies and engage in dialogue with Anvisa to strengthen a modern, safe regulatory framework that fulfills Anvisa's institutional purpose of promoting and protecting health."

The Central Points of the Postponed Review

The draft presented by rapporteur Rômison Mota included significant changes, particularly regarding the restriction on imports.

The proposal suggests that the importation of cannabis products by individuals, via RDC No. 660/2022, will only be permitted if there is no equivalent product — in the same pharmaceutical form and concentration — already regulated and available in the national market.

Other notable points include:

The maintenance of the THC limit above 0.2% only for use in palliative care for patients with irreversible conditions, being contraindicated for those under 18 years old.

The requirement for quality control in the national territory for all batches, including imported ones.

The exclusive sale in pharmacies with prescription retention and specific labeling, with a black stripe for products with high THC content.

The extended deadline of 12 months for the import restriction to come into effect aims to give the national market time to adapt and ensure the supply for patients before the domestic purchase priority becomes mandatory.

The review process of RDC 327, now in deliberative circuit, is expected to have its final opinion defined in the first half of January 2026.