ANVISA Releases New Guidelines for Controlled Substances and Medical Products

On September 6, 2024, ANVISA (Brazil’s National Health Surveillance Agency) issued Resolution RDC 902/2024 which introduces updated regulatory requirements aimed at enhancing the control of substances and products under sanitary surveillance in Brazil.

Key Changes for Controlled Substances and Medical Products

The Resolution outlines important changes that affect:

• The registration and renewal procedures for controlled substances.

• The criteria for labeling, storage, and distribution of medical products.

• New measures to ensure the safe marketing and distribution of these substances in Brazilian markets.

Increased Monitoring and Reporting Requirements

One of the key aspects of the new resolution is its focus on strengthening the monitoring mechanisms for substances considered to have a high potential for abuse or risk to ensure that they are only used in a regulated and controlled manner. This includes new guidelines for handling, dispensing, and reporting activities related to controlled substances.

Additionally, RDC 902/2024 outlines specific requirements for facilities involved in the manufacture, distribution, and sale of these products, including the need for enhanced tracking systems and detailed reporting to ensure full transparency throughout the supply chain.

Implementation Timeline and Compliance Advice

The resolution is part of ANVISA’s broader strategy to enhance public health and safety by reducing risks associated with the improper use of controlled substances while streamlining regulatory procedures for compliant businesses.

The new guidelines will take effect in the coming months, and companies operating in this sector are encouraged to familiarize themselves with the new requirements to ensure compliance and avoid disruption to their operations.