Anvisa publishes new RDC 1.015 and redefines the regulatory framework for medicinal cannabis in Brazil

The National Health Surveillance Agency (Anvisa) published in the Official Gazette of the Union this Monday, February 3, 2026, the Collegiate Board Resolution (RDC) No. 1,015, which establishes a new set of rules for the manufacture, import, commercialization, prescription, and monitoring of cannabis products for human medicinal use in Brazil. The standard represents one of the most relevant regulatory advancements since the creation of the sanitary authorization regime and redefines the positioning of these products within the national drug policy.

New regulatory framework redefines medicinal cannabis products in Brazil

The new resolution more precisely delimits the scope of the so-called cannabis products, restricting authorization exclusively to industrialized pharmaceutical products containing as an active ingredient the phytomedicine cannabidiol (CBD) or extracts of CBD-dominant chemotype of Cannabis sativa L. Cosmetics, food, smoking products, medical devices, and any other categories that do not qualify as pharmaceutical products intended for human medicinal use remain outside the scope of the standard.

CBD as a central axis: what is included and what is excluded from the standard

By focusing the authorization on industrialized products based on CBD or CBD-dominant extracts, RDC No. 1,015 definitively distances itself from broader interpretations that had been explored in the market. The measure reinforces the pharmaceutical logic of regulation and expressly excludes products marketed under other classifications, even if derived from cannabis.

THC limit maintained, with exceptions for severe diseases

One of the central points of RDC No. 1,015 is the maintenance of the limit of up to 0.2% of tetrahydrocannabinol (THC) in authorized products, except for those developed exclusively for the treatment of severe debilitating diseases or life-threatening conditions. In these cases, the standard imposes additional restrictions, prohibiting use in individuals under 18 years of age, pregnant and lactating women, in addition to requiring a thorough benefit-risk assessment by the prescribing professional in elderly patients or those with a history of cannabis dependence.

Tighter medical prescription and requirement of informed consent

The resolution also reinforces the technical and ethical responsibility of prescribers, restricting the prescription of cannabis products to legally qualified physicians and dentists, exclusively for patients with no satisfactory therapeutic alternative with regulated medicines in the country. The prescription must clearly identify the authorized product, its concentration, and the applicable control regimen, and must be accompanied by the signed Informed Consent Form by the patient and the healthcare professional.

Sanitary authorization becomes transitional

From a regulatory perspective, Anvisa consolidates the Sanitary Authorization as an individual act per product and per commercial presentation, valid for five years. At the end of this period, the holding company must obligatorily submit the product for registration as a medicine, supported by a structured clinical development plan.

The possibility of renewing the authorization, provided only once and for an equal period, now depends on the demonstration of effective progress in clinical studies, including a viable schedule and ethical and regulatory approval of the protocols.

Technical and industrial requirements approach medicine registration

The text of RDC No. 1,015 significantly expands the list of technical documents required for authorization. Companies must provide detailed reports on pharmaceutical development, scientific rationale for choosing the cannabinoid profile, accelerated and long-term stability studies, validated analytical methods, quality control in national territory, and evidence of compliance with Good Manufacturing Practices at all stages of the production chain, from cultivation to the finished product.

Stricter labeling and prohibition of common commercial terms

In the field of labeling and patient information, the standard adopts an even more restrictive stance. The use of widely disseminated terms in the international market, such as "CBD oil," "full spectrum," "broad spectrum," or "full extract," as well as any direct or indirect mention of therapeutic indications, dosage, or efficacy claims, is expressly prohibited.

All products must contain standardized warnings, with emphasis on the warning phrase that reinforces that the product is not considered a medicine and has not been evaluated for its efficacy and safety by Anvisa.

Traceability and pharmacovigilance take center stage

The resolution also strengthens traceability, pharmacovigilance, and post-commercialization monitoring mechanisms, requiring companies to maintain structured databases for recording adverse events, quality deviations, and periodic benefit-risk assessment reports. Anvisa now has clearer instruments for adopting regulatory measures, including recalls and authorization cancellations, whenever risks to public health are identified.