The cannabis sector has entered a decisive month for its future. The Federal Government has until September 30th to publish the ordinance that regulates and supervises the production and access to cannabis derivatives for exclusively medicinal purposes.

The requirement was formalized in an acórdão from the 1st Section of the Superior Court of Justice (STJ), in the proceedings of the Competence Assumption Incident (IAC no. 16). Initially, the deadline was set for May 19th, but the STJ approved an “additional deadline” until September, after the Attorney General's Office (AGU) presented an Action Plan for the Regulation and Supervision of Access to Drug Treatments Based on Cannabis.

The STJ collegial body highlighted the difference between industrial hemp and other varieties of Cannabis sativa used for psychoactive purposes. With a low THC content (less than 0.3%), hemp does not produce psychoactive effects, which sets it apart from other plant variations used as narcotics. Therefore, the Court concluded that hemp is not subject to the prohibitions of the Drug Law (Law no. 11,343/2006), allowing its cultivation in national territory.

Articulation aiming at the final deadline

The Action Plan guiding this regulation involves the participation of various Executive bodies and dialogue with experts, patient associations, scientific institutions, and representatives of the regulated sector. Among the actors are the ministries of Health (MS), Justice and Public Security (MJSP), Agriculture and Livestock (MAPA), Agrarian Development and Family Agriculture (MDA), and the National Health Surveillance Agency (Anvisa).

With deadlines set in nine stages, six of which are scheduled until September 29th and three more until the final deadline on September 30th, the Government enters the final stretch of regulation, with few barriers overcome, according to the STJ. On August 20th, Minister Regina Helena Costa issued a monocratic decision to assess the Government's actions.

As the only completed stage, stage no. 2, under MAPA's responsibility. To comply with this topic, the Ministry published Ordinance SDA/MAPA no. 1,342, which defines phytosanitary requirements for the importation of Cannabis sativa seeds. The document requires a phytosanitary certificate issued by the country of origin, attesting to the absence of specific pests.

Phytosanitary inspection upon the product's entry into Brazil is also foreseen, with sample collection for laboratory analysis. The costs are borne by the importer.

Irregularities pointed out by the STJ

Among the irregularities pointed out by Minister Regina Helena, three stand out. Stage no. 3, under MAPA's responsibility, foresaw the approval of a technical note on the registration process of producers of Cannabis sativa propagative material, with a deadline until June 26th, which had no "evidence of compliance".

The Sechat Portal, in an investigation, tried to contact MAPA representatives to understand the delays, but, as of 1:23 PM on September 1st, 2025, the time of publication of the article, “the responsible person was not found”.

Stage no. 4, with a deadline until July 17th, deals with the elaboration of a technical version of the draft Ordinance that will regulate the cultivation and access to medicinal cannabis derivatives. According to the minister, the Government did not provide “material evidence of efforts made” to demonstrate progress in this regard.

Stage no. 5, which foresaw an expanded discussion of the technical draft until August 15th, also did not show any formal manifestation, according to the STJ, reinforcing signs of delays in execution.

Health's role and RDC removed from the agenda

Another point in the document is stage no. 9, under Anvisa's responsibility. It foresees the approval of a Collegiate Board Resolution (RDC) to exclude from the control of Ordinance SVS/MS no. 344/1998 Cannabis sativa L. with a THC content equal to or less than 0.3% in dried inflorescences.

The issue was on the agenda of the 12th meeting of the Collegiate Board (Dicol), but was removed by the rapporteur, director Daniel Pereira. At the time, the agency did not yet have its full board of directors — a situation that changed on August 28th, with the approval of the director-president and two new members by President Lula.

Also considered crucial by the document, stage no. 6 provides for the consolidation of contributions and drafting of the final version of the draft Ordinance, which deals with the regulation and supervision of the production and access to cannabis derivatives for exclusively medicinal purposes. This stage, scheduled for delivery by October 29th, is the responsibility of the Ministry of Health.

In response to Sechat Portal's article, the Ministry stated that it is “completing the stages” scheduled in the timeline.

STJ demands immediate proof

In the ruling of August 20th, Minister Regina Helena Costa ordered the Union and Anvisa to prove, within five days, the execution of stage no. 3 and present concrete measures regarding stages no. 4 and no. 5.

At the beginning of August, she had already requested a statement from the responsible agencies, reinforcing the pressure for the timeline to be met by the deadline of September 30th.