RDC 327/2019: manufacturing and sale of cannabis products

What it is and regulatory context

RDC 327/2019 was Anvisa's pioneering resolution in creating a specific category for Cannabis products in Brazil, allowing their manufacturing, import, commercialization, prescription and dispensing in pharmacies. Conceived as a transitional rule — with an initial validity of three years, later extended —, it inaugurated the regulated medical-cannabis market in the country and paved the way for products to reach the shelves under health control.

What the rule establishes

The resolution defines the requirements for obtaining the Sanitary Authorization (AS), a more agile path than drug registration, aimed at cannabis products with adequately demonstrated quality and safety. It sets rules for Good Manufacturing Practices, labeling, packaging, quality control and pharmacovigilance, and restricts sale to dispensing in pharmacies with a prescription. The products have concentration limits and specific origin and composition requirements.

Who it applies to and impacts

It applies to companies that manufacture or import cannabis products for the Brazilian market. It was under RDC 327 that the first products with Sanitary Authorization sold in national pharmacies emerged, consolidating a formal supply chain. With the new 2026 regulatory framework, the rule will be replaced by RDC 1,015/2026, which requires companies to plan the migration of their authorizations and adaptation to the new requirements.

Deadlines, validity and access

RDC 327/2019 remains the reference until the full effect of RDC 1,015/2026, which replaces it (expected for May 2026). Companies with authorized products will need to adapt to the new rules within the transition deadlines. Brazcann supports regulatory structuring and migration end to end. The official text is available on the Anvisa portal. Informative content, not a legal opinion.

Why this matters

Understanding RDC 327 remains essential even at the moment of its replacement. Companies that built their portfolios under this rule need to map, in advance, exactly what changes with RDC 1,015/2026, to preserve their authorizations and commercial continuity. Errors or delays in this transition can mean the loss of products already established in the market and the interruption of supply to patients. For this reason, planning the migration — with a review of dossiers, processes and deadlines — should start early. Brazcann performs this transition diagnosis and conducts the technical and documentary adaptation needed for a safe, uninterrupted migration.

Frequently asked questions

Is RDC 327 still valid?

It remains the reference until the full effect of RDC 1,015/2026, which replaces it.

What is the Sanitary Authorization?

A more agile path than drug registration to commercialize cannabis products in pharmacies.