Central Africa Track and Trace Regulations: Building a Unified Pharmaceutical Portal

Central Africa Track and Trace Regulations: Building a Unified Pharmaceutical Portal

Central African nations, including Cameroon, Gabon, the Republic of Congo, Chad, and the Central African Republic, are making significant strides towards ensuring pharmaceutical supply chain security by collaborating on a unified Central Africa track and trace regulations framework. Inspired by global examples such as EUFMD, this initiative aims to create a centralized portal for tracking and tracing pharmaceuticals across multiple countries in the region.

By implementing harmonized Central Africa track and trace regulations, these countries seek to enhance transparency, combat counterfeit medicines, and ensure regulatory compliance. The system will enable real-time monitoring of pharmaceutical products, improving patient safety and strengthening the overall healthcare ecosystem in Central Africa.

Key Highlights of Central Africa Track and Trace Regulations

The collaborative effort among Central African nations focuses on several core components:

  1. Centralized Portal: A regional platform will serve as a single source of truth for pharmaceutical traceability, facilitating cross-border regulatory compliance.
  2. Serialization: All pharmaceutical products will carry a unique identifier encoded in a GS1-compliant Data Matrix barcode, containing the GTIN (Global Trade Item Number), batch number, expiration date, and serial number.
  3. Aggregation: The system will track pharmaceuticals from individual units to secondary and tertiary packaging, enabling comprehensive traceability.
  4. Stakeholder Reporting: Manufacturers, importers, distributors, and healthcare facilities will report traceability data to the centralized portal.
  5. Verification and Consumer Tools: The system will offer real-time verification tools for stakeholders and consumers, ensuring product authenticity at every stage.
Central Africa Track And Trace Regulations

Implementation Timeline

The implementation of Central Africa track and trace regulations is structured to ensure smooth adoption by all stakeholders. The timeline is as follows:

  • 2024: Formation of the governing body and pilot projects with selected high-risk products.
  • 2025: Mandatory serialization for all pharmaceutical products within participating countries.
  • 2026: Aggregation requirements come into effect, extending to over-the-counter (OTC) drugs.
  • 2027: Full integration of cross-border pharmaceutical traceability within the unified portal.

Barcode Requirements

To align with global standards, the Central Africa track and trace regulations initiative will require the use of GS1 Data Matrix codes. These barcodes are widely recognized for their:

  • High Data Capacity: Capable of storing extensive product information, including GTIN, batch number, serial number, and expiration date. This allows for detailed tracking of each product through the supply chain.
  • Durability: Resistant to physical damage, including scratches and smudges, ensuring readability even in harsh environments common in transportation and storage facilities.
  • Tamper Evidence: The use of these barcodes often incorporates tamper-evident packaging, adding an extra layer of security against counterfeiting.
  • Global Interoperability: Compliance with GS1 standards ensures seamless integration with other national and international track and trace systems.

Market Context and Counterfeit Drug Issues

The Central Africa track and trace regulations framework is crucial for securing the region’s $5 billion pharmaceutical market, which is expected to grow annually due to increased healthcare access and population growth. However, counterfeit drugs remain a major concern, accounting for nearly 30% of all medicines in circulation in some areas. These counterfeit products not only threaten public health but also result in economic losses estimated at $200 million annually. Implementing a robust Central Africa track and trace regulations system will help combat these challenges by ensuring transparency and security in the pharmaceutical supply chain.

By implementing robust barcode requirements and a centralized portal, Central Africa track and trace regulations aim to address these challenges and significantly reduce the circulation of counterfeit medicines.

The Role of the Unified Portal in Pharmaceutical Traceability

The centralized portal will revolutionize how pharmaceuticals are tracked and traced across the region:

  1. Data Centralization: All serialization and aggregation data will be stored in a secure, unified platform.
  2. Cross-Border Compliance: Regulatory authorities across participating nations will have real-time access to traceability data, ensuring consistency and transparency.
  3. Consumer Empowerment: The portal will provide mobile and web-based tools for consumers to verify product authenticity, fostering trust and safety.

VISIOTT-TPS Solutions for Central Africa’s Track and Trace Needs

VISIOTT-TPS offers cutting-edge solutions designed to meet the unique requirements of Central Africa track and trace initiative. Our offerings include:

  • High-Speed Serialization Stations: Capable of applying GS1 Data Matrix codes to vials, cartons, and bottles with precision.
  • Aggregation Solutions: Seamlessly integrate packaging hierarchy data, ensuring comprehensive traceability.
  • Logistic Operations and Aggregation: VISIOTT-TPS provides solutions that streamline logistics by integrating aggregation data with transportation and warehousing processes, ensuring real-time updates and traceability.
  • Level 4 Software Solutions: VISIOTT-TPS advanced Level 4 solutions enable seamless data reporting, regulatory compliance, and centralized monitoring of serialization and aggregation data, fully compatible with Central Africa’s unified portal.
  • Custom Software Platforms: Enable serialization, aggregation, and reporting compliance with the unified portal.

Achieving Compliance with Central Africa Track and Trace Regulations

Compliance with Central Africa track and trace regulations is essential for pharmaceutical companies operating in the region. VISIOTT-TPS provides robust hardware and software solutions to ensure seamless adherence to these requirements. Our 24/7 support and innovative technologies make us the preferred partner for serialization and aggregation needs, helping businesses stay compliant with Central Africa track and trace regulations while enhancing supply chain security.

Contact our experts today to learn how our tailored solutions can support your compliance journey in Central Africa!

Regulatory advancements in track and trace systems are shaping pharmaceutical supply chain security worldwide. While Central African nations are working on a unified framework, successful implementations can be seen in the Egypt track and trace regulations and Bahrain track and trace regulations. These initiatives serve as valuable references for strengthening compliance and transparency in pharmaceutical distribution.

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