The Brazilian Health Regulatory Agency (Anvisa) has introduced regulations aimed at bolstering public health defenses and operational efficiency in ports, airports, and customs facilities. The updated rules, outlined in Resolutions RDC 932/2024, RDC 938/2024, and RDC 939/2024, mark significant advancements in epidemiological surveillance, contingency planning, and storage practices for goods subject to health regulations.
Strengthening Epidemiological Surveillance
Effective November 14, 2024, RDC 932/2024 updates health monitoring procedures in ports, airports, and oil platforms. Its goal is to reduce the risk of disease entry and spread via travelers and goods. Key updates include:
- Mandatory Contingency Plans: Facility administrators must now implement contingency plans guided by Anvisa’s “Guide 75/2024.” This document emphasizes preparation, response to public health events (PHEs), and simulated exercises for testing protocols.
- Empowered Local Management: Administrators and operators now have a more active role in managing PHEs, reducing reliance on Anvisa’s evaluation for all health issues. Qualified health professionals will assess events, escalating cases to health authorities as needed.
- Streamlined Procedures: New measures simplify handling travelers with non-threatening health conditions, ensuring smoother operations.
- Automated Vaccination Certificates: International vaccination certificates are now issued through the “Meu SUS Digital” platform, reducing procedural delays.
Anvisa has also released Technical Note 19/2024, detailing operational requirements and health measures for designated entry points.
Enhanced Standards for Customs Facilities
Anvisa has introduced RDC 938/2024 and RDC 939/2024, both enacted on November 14, 2024, to optimize service regularization and health safety in ports, airports, and customs zones.
RDC 938/2024: Good Storage Practices
This resolution revises storage requirements for goods under health surveillance, aligning with prior regulations such as RDC 430/2020 (medicines) and RDC 665/2022 (health products). Significant updates include:
- Detailed quality management system requirements.
- Specific areas for physical and remote cargo inspections, including refrigerated zones.
- Continuous temperature monitoring and alarm systems for sensitive goods.
- Four-year validity for Good Storage Practices certification, matching international standards.
Inspections now prioritize compliance with storage practices over infrastructure, assessing cargo handling, quality management, and traceability.
RDC 939/2024: Simplified Authorization Procedures
RDC 939/2024 consolidates the criteria for obtaining Authorizations for Operation (Autorização de Funcionamento – AFE) and Special Authorizations (Autorização Especial – AE). Major changes include:
- Dispensing AFE for Low-Risk Services: Activities like cleaning, waste management, and medical assistance in customs areas no longer require AFE but remain subject to inspection.
- Mandatory AFE for Storage Activities: Businesses handling goods under health surveillance must petition for AFE or AE through the centralized “Solicita” system before operations begin.
Collaborative and Risk-Based Approach
These health regulations for ports and airports were developed through regulatory impact analysis and public consultation. They emphasize harmonizing processes, optimizing inspection resources, and focusing on risk-based evaluations to protect public health while facilitating efficient trade and travel operations.