As of April 4, 2025, Anvisa launched a public consultation (CP 1.316/2025) to update the rules on cannabis products for medicinal use in Brazil. The deadline for contributions will be 60 days.
1. Objective of the update
Anvisa aims to improve RDC 327/2019 to ensure greater quality and safety in cannabis products, meeting growing demand and based on the best scientific evidence.
2. Main proposals
- Good Manufacturing Practices (GMP): Manufacturing companies need to be certified by Anvisa according to GMP.
- New routes of administration: Proposal to include dermatological, sublingual and buccal routes, in addition to those already allowed (oral and nasal).
- Expanded Prescription: Dental surgeons will also be able to prescribe cannabis products.
- Prescription and Dispensing: Change in the types of prescription, with products up to 0.2% THC being able to be prescribed with a simple prescription.
- Manipulation in Pharmacies: Discussion on the possibility of handling purified CBD.
- Authorization period: Health authorization may be renewed for another 5 years if there is ongoing clinical research.
3. Participation in the Public Consultation
The deadline for submitting contributions is June 4, 2025. Visit the Anvisa website to send your suggestions.
4. Background
The review began in 2022 and seeks to balance access to products with the safety of use, considering the lack of conclusive evidence on the efficacy of many cannabis products.
Conclusion
The review of the rules for medical cannabis products represents an opportunity to improve regulation, ensuring safer and more efficient access for patients. The participation of society is essential to the success of this update. If you are interested in the subject, take advantage of the public consultation to contribute suggestions that could improve the regulation of these products in Brazil.