Brazil National Agency of Sanitary Surveillance

DSCSA Track and Trace Compliance Solutions

Ensuring Pharmaceutical Integrity: Brazil ANVISA's Traceability Mandate

In Brazil, the pharmaceutical landscape is underpinned by a commitment to ensuring the safety and authenticity of medicinal products. The Brazil National Agency of Sanitary Surveillance (ANVISA) has implemented stringent traceability requirements aimed at fortifying the pharmaceutical supply chain. These regulations are designed to combat counterfeit drugs, enhance patient safety, and provide regulatory authorities with improved visibility into the movement of pharmaceuticals throughout the distribution network.


Key Components

Unique Identification and Serialization

ANVISA mandates that pharmaceutical products carry a unique identification code and serial number. This serialization allows for precise tracking and tracing of each unit, facilitating rapid identification of the product's origin and movement through the supply chain.

Data Reporting and Integration

Pharmaceutical manufacturers are required to submit detailed data to ANVISA at various stages of the supply chain, creating a comprehensive digital trail. This data encompasses information on production, distribution, and sales, enabling ANVISA to monitor and regulate the industry effectively.

Compliance and Enforcement

ANVISA's traceability requirements are accompanied by strict compliance measures. Non-compliance can lead to severe penalties, including fines and product recalls. Regular inspections and audits are conducted to ensure that all stakeholders in the pharmaceutical supply chain adhere to the traceability regulations.

Partnering for Compliance

Navigating the complexities of ANVISA's traceability requirements demands a strategic and informed approach. Our team of experts specializes in guiding pharmaceutical entities through the implementation of robust traceability systems. From serialization strategies to data integration solutions, we provide tailored services to ensure compliance and foster a secure and transparent pharmaceutical supply chain.

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As pharmaceutical traceability takes center stage in Brazil, compliance with ANVISA's regulations is not only a legal requirement but a testament to a commitment to public health. Partner with us to navigate the intricacies of traceability, fortifying your position as a responsible and compliant participant in Brazil's pharmaceutical industry. Contact us today to embark on a journey towards pharmaceutical integrity and regulatory excellence.

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