On March 26, 2025, the public consultation on the revision of RDC 327/2019, which regulates the health authorization, manufacture, import, marketing, prescription and inspection of cannabis-based products for medicinal purposes in Brazil, was approved. Below are the main changes discussed at the meeting.
Main changes proposed
1.Prescription
Products with less than 0.2% THC can be prescribed with a special control prescription, without the need for a Type B Prescription Notification.
Products with more than 0.2% THC will be restricted to patients with serious illnesses and cannot be prescribed to children under 18, pregnant women or nursing mothers.
Prescription will be allowed by legally qualified doctors and dental surgeons, with adjustments to the type of prescription according to the THC content.
2. Good Manufacturing Practices (GMP)
GMP certification required for final products.
Active pharmaceutical ingredients must comply with GMP in accordance with RDC 654/22, without the need for additional certification by Anvisa.
3. Routes of Administration and Manipulation Pharmacies
Expansion of administration routes, allowing oral, buccal, sublingual, inhalation and dermatological forms. Injectable products and smoking are still prohibited.
Handling pharmacies will only be able to operate with purified CBD (≥98% purity), ensuring greater quality control.
4. Imports and production
Regulations for the import of raw materials and products in bulk.
Exclusion of the possibility for compounding pharmacies to import CBD phytopharmaceuticals directly.
5. Advertising
Advertising restrictions, similar to those for medicines subject to special control, allowed only for health professionals.
Criticism of RDC 660/22
RDC 660/22 allows importation by individuals without health registration, which can create risks to patient safety.
International studies indicate inconsistencies in the levels of CBD and THC in imported products, suggesting a lack of quality control.
It was proposed that RDC 660/22 be revised to align the regulatory framework and strengthen inspection.
Next Steps and Public Consultation
The revision of RDC 660/22 will be discussed at another meeting, due to the lack of a quorum for deliberation at this session. Director Daniel Pereira will be in charge.
The public consultation will remain open for 60 days, allowing society to participate in discussions on the proposed changes.
