Anvisa updates control of substances and redefines rules for medicinal cannabis

The National Health Surveillance Agency (Anvisa) published, on January 30, 2026, the Resolution of the Collegiate Board of Directors (RDC) No. 1,011, which updates the lists of substances subject to special control and redefines regulatory criteria that directly impact the medicinal cannabis sector in Brazil. The standard details the classification of medicines, cannabis products, pharmaceutical inputs, and derivatives of Cannabis sativa, expanding the scope and precision of health control.

Expansion of control over chemical forms of substances

The resolution establishes that salts, ethers, esters, and isomers of the listed substances are under control whenever their existence is possible, as well as the salts of these variations. The provision broadens regulatory reach by including different chemical forms of controlled substances, reducing divergent interpretations of their application.

Parameters for medicines with Cannabis derivatives

In the field of medicinal cannabis, RDC No. 1,011 determines that medicines registered with Anvisa containing derivatives of Cannabis sativa in their formulation remain subject to list controls when they have a concentration of up to 30 mg of tetrahydrocannabinol (THC) per milliliter and up to 30 mg of cannabidiol (CBD) per milliliter. The text consolidates maximum parameters for medicines with cannabinoids, reinforcing their classification as substances of special control.

THC concentration defines regulatory classification

The standard deepens regulatory differentiation based on THC concentration. Cannabis products regularized under RDC No. 327, of December 9, 2019, or any subsequent regulation, become subject to list controls when they have a THC content above 0.2%. Simultaneously, the resolution provides specific classification for products containing up to 0.2% THC, making it clear that, regardless of the concentration range, cannabis derivatives remain under defined health control regimes.

Pharmaceutical inputs included in control scope

Another key point of RDC No. 1,011 is the explicit inclusion of pharmaceutical inputs based on derivatives of Cannabis sativa in the special control system. The resolution determines that inputs in the forms of plant derivatives, phytopharmaceuticals, and bulk, intended for the manufacture of regularized Cannabis Products, are subject to list requirements. The measure affects stages prior to the final formulation, directly impacting the sector's production chain.

Rules also apply to veterinary products

Regulatory control also extends to veterinary products for medicinal purposes regularized with the Ministry of Agriculture and Livestock (Mapa). According to the standard, both veterinary products based on derivatives of Cannabis sativa and pharmaceutical inputs used in their manufacture are subject to the same controls applicable to human use products.

Dronabinol and exceptions provided in the standard

RDC No. 1,011 clarifies the regulatory treatment of dronabinol, establishing that the substance is only subject to list controls when obtained synthetically and provided that no other components subject to special control are present, even as impurities. The text also provides exceptions for isomers not listed nominally and that are components of medicines registered with Anvisa, as well as for the medicines containing them.

Plant species with low THC content under control

Finally, the resolution includes the plant species Cannabis sativa L. that proves to produce THC content lower or equal to 0.3% within the scope of health control, as per the corresponding addendum. The measure reinforces the regulatory classification of plant material and aligns with the broader context of recent Anvisa decisions on medicinal cannabis, already analyzed by the Sechat portal in monitoring resolutions related to cultivation and sector regulation.