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LSPEdia connected country
LSPEdia connected country
LSPEdia connected country
LSPEdia connected country
LSPEdia connected country
LSPEdia connected country
LSPEdia connected country
LSPEdia connected country
LSPEdia connected country
LSPEdia connected country
LSPEdia connected country

BPOM

Strengthening Pharmaceutical Integrity: Indonesia's BPOM Track and Trace Framework

Indonesia's BPOM Track and Trace Framework

Indonesia's National Agency of Drug and Food Control (BPOM) has established one of Southeast Asia's most comprehensive pharmaceutical traceability systems through its Track and Trace Anti-Counterfeit (TTAC) framework. This robust regulatory mandate demonstrates Indonesia's commitment to combating counterfeit medicines, enhancing supply chain transparency, and safeguarding public health across its vast archipelago nation.

Key Pillars of BPOM's Track and Trace Mandate

Dual-Barcode Authentication System

BPOM's innovative approach implements a two-tier barcode system for comprehensive product verification. Identification barcodes (QR codes) have been mandatory since December 2023 for traditional medicines, over-the-counter drugs, cosmetics, and supplements, serving to verify product legality in the market. Authentication barcodes using GS1 2D DataMatrix codes will be phased in by December 2025 for narcotics and psychotropics, and by December 2027 for all prescription drugs, enabling granular serialization with GTIN, batch numbers, and expiry dates.

Comprehensive Product Scope Coverage

The regulation encompasses an extensive range of products beyond traditional pharmaceuticals, including traditional medicines, over-the-counter drugs, prescription medicines, biologicals, cosmetics, supplements, processed foods, and certain raw materials. This broad scope ensures that both imported and locally produced products throughout Indonesia's diverse healthcare and consumer markets maintain consistent traceability standards, creating a unified framework for product authentication.

Mandatory Packaging Hierarchy and Aggregation

BPOM requires detailed documentation of packaging relationships from sellable units through cases to pallets, establishing clear parent-child connections throughout the packaging hierarchy. Companies must implement aggregation at production lines and report this data to the TTAC system, enabling precise tracking of product movements and supporting efficient recall procedures when necessary.

Centralized TTAC System Integration

All traceability documentation and reporting must flow through BPOM's centralized Track and Trace Anti-Counterfeit platform, ensuring real-time monitoring and regulatory compliance. The system also supports the transition to electronic product leaflets (e-leaflets) accessible via packaging barcodes, modernizing how healthcare providers and consumers access critical product information while reducing environmental impact.

Why Choose Our iTS Compliance Solution

Expert Guidance

Our team of compliance experts possesses in-depth knowledge of iTS and Turkish pharmaceutical regulations. From serialization strategies to data reporting, we guide your organization through the intricacies of compliance, ensuring a smooth and informed journey.

Cutting-Edge Technology

Leverage our state-of-the-art compliance solution, designed to integrate seamlessly with iTS requirements. Our technology ensures accuracy, efficiency, and real-time visibility, empowering your organization to meet and exceed compliance expectations.

Future-Ready Operations

Compliance is not just about meeting today's standards; it's about preparing for the future. Our solution is designed to evolve with regulatory changes, ensuring that your organization remains at the forefront of compliance in the dynamic Turkish pharmaceutical landscape.

Transparent Collaboration

We believe in transparent collaboration. Partner with us, and we'll work closely with your team to implement and maintain compliance measures. Our goal is to build a resilient, compliant, and future-ready pharmaceutical supply chain together.

Speak With a Compliance Expert

How LSPedia Facilitates BPOM Compliance Excellence

Our specialized expertise in Indonesia's BPOM regulations positions pharmaceutical companies for seamless compliance with the TTAC framework. LSPedia's comprehensive solution suite addresses the complex dual-barcode requirements, aggregation mandates, and centralized reporting obligations that define Indonesia's regulatory landscape. From implementing GS1-compliant serialization systems to establishing robust data integration with the TTAC platform, our team guides organizations through every aspect of compliance. We ensure your production lines, packaging processes, and supply chain operations align perfectly with BPOM's phased implementation timeline, helping you meet the December 2025 and 2027 deadlines while maintaining operational efficiency throughout Indonesia's dynamic pharmaceutical market.

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We invite you to learn more about how LSPedia can support your compliance and supply chain needs. For more information about our solutions, partnership opportunities, or to speak with one of our experts.

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