Review of RDC 660 reignites debate on competitiveness and access to imported products

The Collegiate Board of the National Health Surveillance Agency (Anvisa) approved, on Wednesday (28), the new regulation of Cannabis in Brazil, focusing on the update of RDC 327. 

Much debated, the review of RDC 660, which regulates exceptional importation by individuals, was maintained in its own exclusive regulatory process, which is expected to begin in the first quarter of the year, due to the unanimous request for urgency. 

According to the Agency, separating the processes aims to allow the review of RDC 660 to occur in a planned manner, avoiding access failures. For Marcelo De Vita Grecco, consultant and co-founder of The Green Hub, the separation was a crisis management measure. 

"Anvisa knew that RDC 660 served as a safety valve to prevent shortages. Trying to impose the requirements of RDC 327 now would cause a collapse in access," he states.

Legal Security and Political Strategy

The isolation of the regulation is interpreted in different ways by the sector. Allan Paiotti, CEO of Cannect, believes that the measure ensures long-term planning and avoids discontinuity in patient treatment.

"Anvisa recognized the importance of individual importation and opted for a structured review of RDC 660," points out Paiotti. For him, maintaining the current scenario provides legal security to the ecosystem.

The executive emphasizes that the competitiveness of imported products remains stable. He points out that the formats of RDC 660 and RDC 327 are complementary and allow for sustainable market growth.

Challenges and Impact on Competitiveness

A central point in the new process will be the alignment of quality requirements between access models. For Paiotti, importation is still the main avenue for formulations not available in the national retail market.

"Importation via 660 is a central axis of the regulatory debate," notes Paiotti. He hopes that the review of RDC 660 will bring a progressive alignment to the quality parameters of the new 327, focusing on patient safety and product traceability.

Grecco, on the other hand, warns that the review of RDC 660 may hinder smaller international producers through technical bureaucracy. "The killer of small players will be the requirement for stability studies for tropical climates," he predicts.

The consultant believes that Anvisa will create a "technical cost filter" where only large companies will be able to comply. "The import model will not be prohibited, but transformed into a monopoly of large players with compliance structures," he concludes.

Complementary Channels and Governance

In a column on the Sechat Portal, published before the vote, physician and member of the Scientific Committee of CBCM 2026 Wellington Briques emphasized that access channels should coexist in an integrated manner. For him, importation will remain relevant for specific cannabinoid profiles.

Briques advocates that the sector adopts a rigorous compliance governance for both channels. The expectation is that the debate on the review of RDC 660 will bring clarity about the responsibilities of prescribers and companies.