Date: February 5, 2026
The ANVISA has published RDC No. 1.015/2026, revising and updating the regulatory framework for granting sanitary authorization for cannabis-based products in Brazil.
This new resolution replaces the previous regulation and introduces several changes with significant commercial and compliance implications. The updated framework will enter into force on May 4, 2026.
Key regulatory changes
1. Expansion of permitted routes of administration
The new regulation explicitly expands the permitted routes of administration:
Article 7. Inhalation, oral, buccal, sublingual, or dermatological routes of administration are permitted for cannabis products.
This clarification broadens formulation possibilities and may support portfolio diversification strategies.
2. GMP certification required for API manufacturing
The regulation now expressly requires proof of compliance with Good Manufacturing Practices (GMP) for the manufacturing line of the active pharmaceutical ingredient (API).
Proof of GMP compliance must be provided by the manufacturer of the active ingredient (API or API-derived substance).
This reinforces supply chain qualification requirements and increases regulatory scrutiny on API manufacturers.
3. Strengthened pharmacovigilance obligations
Beyond the previously required Periodic Benefit–Risk Evaluation Report (RPBR), the new framework mandates the preparation and maintenance of a Risk Management Plan (RMP/PGR).
Article 52. The authorization holder must develop and maintain an updated Risk Management Plan and RPBR, in compliance with RDC 406/2020 and IN 63/2020.
This change increases post-market surveillance responsibilities and ongoing regulatory oversight.
4. Advertising now permitted under restrictions
Previously prohibited, advertising is now expressly regulated:
Article 9. Cannabis products are subject to the advertising restrictions applicable to medicines under special control.
Advertising may only target prescribing professionals and dispensing pharmacists.
This creates controlled promotional opportunities while maintaining strict communication boundaries.
5. Prohibition of duplicate (“Clone”) authorizations
The regulation introduces a strategic limitation :
Article 68. A company holding sanitary authorization for a Cannabis product may not submit a new application for the same product.
Companies within the same economic group are also prohibited from applying for authorization for the same product.
“Same product” is defined as having the same API (or API-derived substance) and pharmaceutical dosage form.
This provision directly impacts corporate structuring, licensing models, and portfolio replication strategies.