Published in December 2019, RDC 327/2019 sets out the procedures for granting Sanitary Authorization for the manufacturing and importation of Cannabis-based products, as well as regulating aspects such as commercialization, prescription, dispensing, monitoring, and oversight of these products in Brazil .
Key Points of RDC 327/2019:
- Sanitary Authorization (SA): ANVISA requires companies intending to manufacture or import Cannabis-based products to apply for Sanitary Authorization. This authorization is valid for 5 years and is granted for each individual product after the requirements are evaluated and approved .
- AFE and AE: In addition to the SA, companies must obtain the Operating Permit (AFE) and the Special Authorization (AE), which are essential for activities related to controlled medicines .
- THC Limitations: Authorized products under RDC 327/2019 must predominantly contain Cannabidiol (CBD) and no more than 0.2% Tetrahydrocannabinol (THC). Exceptions can be made for products intended for palliative care in patients without other therapeutic alternatives .
- Medical Prescription and Monitoring: The prescription of Cannabis products is restricted to licensed physicians, and dispensing must only occur in pharmacies and drugstores. Post-commercialization monitoring is strict, requiring periodic reports to assess the products’ benefits and risks .
- Prohibition of Compounding: Compounding formulas containing Cannabis derivatives is prohibited, as is the distribution of free samples of these products .
RDC 660/2022: Importation of Cannabis-Derived Products for Personal Use
RDC 660/2022, published in March 2022, focuses specifically on the importation of Cannabis-derived products by individuals for personal use, based on a medical prescription. This regulation is particularly relevant for patients needing products not available in the Brazilian market, allowing them to import directly .
Key Points of RDC 660/2022:
- Importation by Individuals: The regulation allows patients or their legal guardians to import Cannabis products for personal treatment, based on a prescription from a licensed medical professional .
- Patient Registration: To proceed with the importation, patients must register with ANVISA via an electronic form. The registration is valid for two years and can be renewed with a new medical prescription .
- Intermediation of Importation: Importation can be facilitated by hospitals, health insurance operators, or governmental health units, providing more ease for patients. However, there are restrictions, such as the prohibition of importation via postal shipments .
- Quality Conditions: As with RDC 327/2019, RDC 660/2022 requires that imported products be produced and distributed by establishments duly regulated in their countries of origin .
Correlation Between the Two RDCs
While both resolutions address the medicinal use of Cannabis, their focuses are different yet complementary:
- RDC 327/2019 focuses on regulating the domestic market, setting rules for companies intending to produce, import, and commercialize Cannabis-based products in Brazil. The goal is to ensure that these products have
pharmaceutical-grade quality and are accessible but under controlled and safe conditions.
- RDC 660/2022, on the other hand, facilitates access for patients to products that are not yet available in the Brazilian market by allowing direct importation for personal use. This RDC represents a significant step forward for patients who require specific treatments and cannot wait for large-scale production or importation .
Together, these resolutions create a solid and comprehensive regulatory environment that seeks to balance patient access to Cannabis treatments with control that the subject requires. the rigorous health
How the Authorization and Importation Processes Work
For companies seeking to enter the medicinal Cannabis market in Brazil, the journey begins with obtaining the AFE and AE, along with the specific Sanitary Authorization for each product. Companies must ensure that their products meet ANVISA’s defined quality and safety requirements. These rules include submitting technical documentation, conducting stability studies, and continuously monitoring the products post-commercialization .
Patients who need Cannabis products unavailable in Brazil can directly import them based on a medical prescription, following the registration and authorization process outlined in RDC 660/2022. This process allows patients to receive the treatments they need, provided the products come from regulated suppliers abroad .
Conclusion
The regulations established by RDC 327/2019 and RDC 660/2022 represent important milestones for access and control of medicinal Cannabis in Brazil. While RDC 327/2019 focuses on structuring the domestic market for Cannabis-based products, RDC 660/2022 allows patients access to international treatments, ensuring the continuity of medical care.
These regulations allow Brazil to advance in the field of medicinal Cannabis in a safe and controlled manner, promoting both industry development and patient well-being.
📝 Access the Resolutions RDC 327/2019 and RDC 660/2022:
EN Version – RDC 327/2019 and RDC 660/2022
The text in the original language of this announcement is the officially authorized version. The translations are provided solely for convenience and should refer to the original language text, which is the only version that has legal effect.
- Click the link to access the Original Version – RDC 327/2019
- Click the link to access the Original Version – RDC 660/2022
In case of doubts, please contact Brisa Advisors for specialized regulatory support.
Find out more about BPO in RA!
*Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
