Uzbekistan Pharmaceutical Traceability: Transition from ASL BELGISI to xTrace

Uzbekistan has enacted new pharmaceutical traceability regulations introducing xTrace, which replaces the existing ASL BELGISI system as the country’s national track and trace framework. The transition to xTrace takes effect through a phased rollout, marking the next stage in Uzbekistan’s serialization and pharmaceutical compliance program.

For pharmaceutical manufacturers, marketing authorization holders (MAHs), importers, and contract packaging organizations supplying products to Uzbekistan, this transition represents an evolution of Uzbekistan’s serialization and track and trace requirements, rather than a fundamental change in obligations. Serialization remains mandatory, but expectations around data structure, validation, and regulatory oversight under the Uzbekistan xTrace system are becoming more clearly defined.

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Why Uzbekistan Introduced xTrace

The ASL BELGISI system established the foundation for Uzbekistan drug traceability and serialization. As the system matured, regulators identified the need for improvements in several areas:

• Data quality and consistency

• System security

• End-to-end traceability across manufacturing and distribution

• Monitoring of counterfeit and diverted medicines

xTrace was introduced to address these gaps and to support long-term scalability of Uzbekistan’s pharmaceutical compliance framework, while aligning more closely with international traceability practices.

What Is Changing in the Uzbekistan xTrace System

More Structured Reporting Requirements

xTrace introduces clearer rules governing what data must be reported and when within the Uzbekistan track and trace system. This reduces ambiguity for regulated companies and supports more consistent regulatory review during inspections and audits.

Tighter Control Over Product Identification

Products supplied to Uzbekistan must use country-specific serial number formats. This improves identification within the Uzbekistan serialization system and reduces the risk of serial numbers being reused across markets.

Increased Oversight of Supply Chain Events

Greater emphasis is placed on accurate data capture during key supply chain events, including:

• Packaging and aggregation

• Shipment and receipt

• Product withdrawal or removal from the market

This enhances visibility across the Uzbekistan pharmaceutical supply chain.

Alignment With Global Traceability Practices

Although xTrace remains a country-specific system, its structure more closely resembles traceability frameworks used in other regulated markets. This can reduce long-term complexity for global companies managing multiple serialization programs.

What Remains the Same

The transition to xTrace does not introduce new supply chain steps or immediate additional obligations under Uzbekistan pharmaceutical regulations. Key requirements remain unchanged:

• Serialization remains mandatory

• Aggregation expectations are unchanged

• Reporting continues through the national system

• Existing serialized inventory remains valid, subject to regulatory guidance

The focus is on how traceability data is structured and validated, rather than operational flow.

Key Compliance Areas to Review

Companies supplying medicines to Uzbekistan should review readiness in the following areas:

Serialization and Packaging Configuration

Ensure serial number formats and labeling configurations align with updated Uzbekistan xTrace requirements.

Master Data Management

Product, facility, batch, and date data must be complete and consistent. Master data issues remain a leading cause of reporting errors in Uzbekistan traceability systems.

Internal Procedures and SOPs

SOPs related to serialization, reporting, and exception handling should reflect updated system expectations.

Partner Alignment

Contract manufacturers, repackers, and logistics providers must operate under the same Uzbekistan compliance requirements to avoid delays or reporting issues.

Transition Approach and Regulatory Direction

Uzbekistan has historically implemented pharmaceutical serialization requirements through phased rollouts. The move from ASL BELGISI to xTrace follows this same approach.

Regulators continue to engage with industry participants and publish guidance as the system evolves. Early preparation and testing remain key to minimizing supply disruption.

Common Readiness Gaps

Organizations preparing for Uzbekistan xTrace should avoid:

• Treating the transition as solely an IT initiative

• Delaying internal reviews until shipments are impacted

• Assuming legacy processes will remain sufficient

• Overlooking master data quality

• Failing to align CMOs and third-party partners

Supporting Uzbekistan Traceability Compliance

As national traceability systems mature, centralized platforms can help companies manage Uzbekistan pharmaceutical compliance more effectively.

Solutions such as OneScan can support xTrace readiness by helping organizations manage master data, validate serialization and aggregation data before reporting, monitor reporting status, and support multiple country requirements.

Conclusion

The transition from ASL BELGISI to xTrace reflects Uzbekistan’s commitment to a more robust and reliable pharmaceutical traceability system.

For regulated companies, success will depend on early preparation, clean data, aligned processes, and strong partner coordination — not last-minute remediation.

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