Public consultation on regulation of medicinal cannabis products opened in Brazil

On March 28, 2025, the Brazilian Health Regulatory Agency (Anvisa) published Public Consultation No. 1,316/2025, seeking contributions for a proposed resolution to regulate cannabis products for human medicinal use. Contributions will be accepted until June 2, 2025.

Anvisa’s Resolution No. 327/2019 (RDC No. 327/2019) previously established requirements for manufacturing, importing, selling, monitoring, inspecting, prescribing, and dispensing industrialized products containing active ingredients derived from plant extracts or phytopharmaceuticals of Cannabis sativa. The resolution sought to create a temporary regulatory framework allowing interested companies to develop sufficient clinical evidence to register these products as medicines.

However, more than five years after RDC No. 327/2019 came into effect, Anvisa has suggested that insufficient scientific evidence exists to achieve the intended goal. In this context, Anvisa’s board unanimously approved the opening of Public Consultation No. 1,316/2025, aiming to collect contributions for a new resolution that will update RDC No. 327/2019.

Various topics addressed in RDC No. 327/2019 may be updated via this new resolution, including:

• New restrictions: Products containing more than 0.2% tetrahydrocannabinol (THC) may be restricted to patients with severe and debilitating diseases.
• Prescriptions: In addition to doctors, dentists would also be able to prescribe cannabis-based products.
• Importation: Cannabis sativa extract, phytopharmaceutical CBD, and bulk industrialized products may be imported into Brazil for the purpose of scientific research, distribution, and development, as well as for manufacturing pharmaceutical ingredients, medicines, or cannabis products inside the country.
• Advertising and promotion: New labeling and advertising regulations would require promotional material to be directed exclusively at prescribing professionals.
• Compounding: Pharmacies specializing in magistral preparations would be able to work with phytopharmaceutical CBD for human medicinal use.
• Routes of administration: In addition to oral and nasal routes, medicines may also be administered buccally, sublingually, or dermatologically.
• Health Authorization: Companies that already have Health Authorizations (Autorização Sanitária) and that have yet to apply to register their product as medicine may apply to renew their authorization in line with the new resolution’s requirements.
• Transition period: Companies would have 90 days to file a petition for label and leaflet modifications and 180 days to implement the changes after Anvisa approves the new resolution.

Anvisa will accept contributions until June 2, 2025. Suggestions and comments can be submitted via a form available on Anvisa’s website.

For more information on the topic, please contact Mattos Filho’s Life Sciences & Healthcare practice area.

*With the collaboration of Marina Castro de Amorim.