Anvisa warns of deadline for comments on agenda including review of RDC 327/2019

The deadline for registration and submission of oral comments and requests for confidentiality on items of the published agenda ends at 11:59 pm on December 5. Instructions and guidelines for watching the meeting broadcast, as well as for registrations, video submissions, and requests, are included in item VIII of this agenda. Special attention is requested for sub-item “t”, regarding the consideration and deliberation of administrative appeals, suspensive effects, and act reviews.

Anvisa published on Tuesday, December 3, the agenda of the Public Ordinary Meeting (ROP 20/2025) of the Collegiate Board of Directors (Dicol), scheduled to take place on December 10, 2025, at 9:30 am, at the Agency's headquarters. Among the highlights of the agenda is item 2.6, which deals with the proposal to update the regulation of cannabis products for medicinal use — a review of RDC 327/2019.

The item also includes the result of the analysis of Public Consultation No. 1,316/2025, which gathered contributions on technical and regulatory changes for the sector. According to the official document, if the item remains on the agenda, the director-rapporteur Rômison Rodrigues Mota will present his vote and open the discussion of the draft for deliberation by the other directors. Each member of Dicol may vote or request a review, which suspends the decision for further analysis.

The review of RDC 327 is on the agenda, and we will only know on the day of the meeting, 12/10, whether the item will be kept or removed, whether it will be voted on, or if any director will request a review. At the beginning of the meeting, the rapporteur of each matter informs whether they will remove any item under their responsibility.

If item 2.6 is kept, the rapporteur will read his vote, and then the directors will start their individual comments. The vote may be concluded in the same session or postponed if any director requests a review of the process.