Bahrain Track and Trace Regulations: Ensuring Pharmaceutical Supply Chain Security

Bahrain Track and Trace Regulations: Ensuring Pharmaceutical Supply Chain Security

Bahrain has recently implemented track and trace regulations, known as Bahrain track and trace regulations, to ensure the safety and authenticity of pharmaceuticals within its supply chain. These measures, designed by the National Health Regulatory Authority (NHRA), aim to combat counterfeit drugs, protect public health, and enhance the transparency of the pharmaceutical industry. This blog explores the key details of Bahrain’s track and trace system, its timeline, and how it aligns with global best practices.

Key Highlights of Bahrain Track and Trace Regulations

Before adopting a centralized track and trace system, Bahrain had established several initiatives to secure its pharmaceutical supply chain. The NHRA, the regulatory authority overseeing these efforts, ensures that all pharmaceutical products are registered and traceable. The key components of the regulation include:

Bahrain Track And Trace Regulations
  1. Serialization: Each pharmaceutical product must have a unique identifier, including a GS1-compliant Data Matrix code containing the GTIN (Global Trade Item Number), batch number, expiration date, and serial number.
  2. Aggregation: Serialization extends beyond individual units to include secondary and tertiary packaging levels, ensuring hierarchical traceability.
  3. Reporting: Manufacturers, importers, and distributors must report serialization data to a centralized database managed by the NHRA.
  4. Verification: The system enables stakeholders, including pharmacies and hospitals, to verify product authenticity in real-time.

Implementation Timeline

Bahrain has established a phased approach for implementing its track and trace regulations, ensuring that stakeholders have sufficient time to comply. Below is the indicative timeline:

  • 2024: Pilot projects begin with selected pharmaceutical products, focusing on serialization and reporting.
  • 2025: Serialization becomes mandatory for all prescription medicines.
  • 2026: Aggregation and reporting requirements are extended to include over-the-counter (OTC) medicines.

Comparing Bahrain and Turkey’s Track and Trace Systems

Bahrain’s approach to pharmaceutical traceability, guided by Bahrain track and trace regulations, draws inspiration from Turkey’s successful implementation of the İlaç Takip Sistemi (ITS), the world’s first end-to-end drug traceability system. Both systems prioritize supply chain transparency and consumer safety. 

Barcode Requirements

Both Bahrain and Turkey utilize GS1 Data Matrix codes as the standard for pharmaceutical serialization. These codes are chosen for their high data capacity, resistance to tampering, and ability to be scanned even if partially damaged.

Comparing Bahrain And Turkey’s Track And Trace System

The Journey of a Serialized Product in Bahrain

Once serialized, pharmaceutical products follow a secure path through the supply chain:

  1. Manufacturers/Importers: Generate serialization data and report it to the NHRA database.
  2. Distributors: Update and maintain the aggregation hierarchy as products are distributed.
  3. Pharmacies/Hospitals: Verify the authenticity of products and report consumption data to the NHRA.
  4. Consumers: Can verify product authenticity through mobile applications or SMS.

VISIOTT’s Solutions for Bahrain’s Track and Trace Needs

VISIOTT, with its extensive experience in serialization and aggregation solutions, provides comprehensive tools to help pharmaceutical companies comply with Bahrain’s regulations. Our solutions include:

  • High-Speed Serialization Stations: Designed for vials, bottles, and cartons, these stations ensure accurate and efficient application of Data Matrix codes.
  • Aggregation Systems: Seamlessly integrate with serialization solutions to maintain hierarchical data at every packaging level.
  • Software Solutions: Manage data reporting, serial number generation, and real-time verification through centralized systems compatible with NHRA requirements.

Achieving Compliance with Bahrain Track and Trace Regulations.

Compliance with Bahrain track and trace regulations is essential for ensuring public health and maintaining consumer trust. VISIOTT-TPS’s innovative and reliable solutions enable pharmaceutical companies to meet these requirements efficiently and effectively. With 24/7 technical support, robust hardware, and scalable software, VISIOTT-TPS is your trusted partner in serialization and aggregation.

Contact our experts today to learn more about how VISIOTT-TPS can support your compliance journey with Bahrain track and trace regulations.

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