The Brazilian Health Regulatory Agency (“ANVISA”) has published a communication reminding companies of the need to fully align the labeling of medicines subject to simplified notification with the requirements established under RDC 768/2022, as updated by RDC 981/2025.

The regulation sets out unified technical parameters for the presentation of labeling information, including legibility requirements, identification of the active ingredient (DCB), storage instructions, mandatory warnings, traceability elements, and standardized visual formatting. The objective is to harmonize safety-related communication to users, reduce inconsistencies, and strengthen the quality of information available across the pharmaceutical market.

In its communication, ANVISA highlights that, while the notification system does not yet support secondary petitions for layout changes, holders of simplified notifications must maintain internal documentation demonstrating compliance with updated artwork until the deadline.

Compliance involves a complete review of artwork, verification of layout against the regulatory parameters, updates to internal procedures, and coordinated action among regulatory, quality, and production teams, particularly to ensure alignment between manufacturing, stock rotation, and the substitution of packaging.

Key practical steps required under the implementation of the RDC include:

• identifying products subject to simplified notification;
• reviewing labeling artwork and verifying compliance with ANVISA’s requirements;
• preparing and filing internal dossiers containing final artwork, printing proofs, and quality-control records;
• implementing operational adjustments across the production chain to ensure proper phase-out of old packaging and introduction of compliant packaging within the deadline;
• updating internal workflows, SOPs, and training for the teams involved in artwork review and approval.

The harmonization of labeling criteria enhances regulatory predictability, supports consistency across manufacturers and distributors, and strengthens end-user safety.

Products already on the market must also meet the updated requirements by the established date, making it essential for companies to plan stock rotation and maintain proper internal tracking of compliance.

Mandatory compliance begins on December 30, 2025.

We are available to assist in assessing regulatory impacts, reviewing labeling, and organizing the technical documentation required to ensure compliance by ANVISA’s deadline.