By Brazil Stock Guide – Brazil’s health regulator Anvisa approved a resolution on Wednesday that significantly expands the country’s framework for medical cannabis therapies, allowing compounded cannabidiol products to be sold by compounding pharmacies, broadening permitted routes of administration and easing restrictions on medicines with higher THC concentrations. The agency said the changes represent an important regulatory advance for patients with severe and debilitating conditions.
Under the new rules, cannabis-based medicines will be permitted for buccal, sublingual and dermatological use. Until now, approved products were largely limited to oral and inhaled administration. The decision was grounded in scientific evidence reviewed during Anvisa’s Regulatory Impact Analysis, which assessed clinical effectiveness, safety and public-health risks.
Broader therapeutic routes
Anvisa said the dermatological route was included because it is considered lower risk, as it limits systemic exposure to cannabinoids. Buccal and sublingual routes were approved for bypassing first-pass liver metabolism, which can improve bioavailability and offer more predictable therapeutic effects. The agency also introduced a technical adjustment by formally replacing the term “nasal route” with “inhalation route,” aligning regulatory language with its existing standards.
Eased access to THC therapies
One of the most consequential changes involves medicines with THC concentrations above 0.2%. Previously restricted to patients in palliative care or with irreversible or terminal conditions, such products may now also be prescribed to patients suffering from severe debilitating diseases. The update substantially broadens the therapeutic scope of THC-based treatments, while maintaining medical oversight and regulatory controls, Anvisa said.
Compounding and patient access
The resolution also authorizes the compounding of cannabis-based medicines by licensed compounding pharmacies, provided prescriptions are individualized. The measure is expected to improve access, reduce costs and allow formulations to be better tailored to patients’ clinical needs.
Controlled communication
While keeping tight limits on commercial communication, Anvisa introduced a narrow relaxation. Advertising of cannabis-based products, previously banned, will now be allowed exclusively for prescribing healthcare professionals. Any such communication must be limited to labeling information and official package leaflets approved by the regulator.
Anvisa stressed that the resolution does not change Brazil’s prohibition of recreational cannabis use. Cannabis and its derivatives remain legal only for medical purposes, under prescription and within the country’s existing sanitary and regulatory framework, reinforcing oversight of a rapidly evolving market.
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