Indonesia Medicines Compliance

BPOM Track and Trace Requirements

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Global Regulations

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Labelling

Products are required to display information in writing.

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Unit Level Traceability

Sellable units are uniquely identified enabling a more granular traceability.

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Aggregation

The packaging hierarchy of products is required to be identified and documented.

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Central repository

The traceability documentation is required to be centralized in a unique system.

Summary

Indonesia is evolving toward full pharmaceutical traceability under the oversight of BPOM (National Agency of Drug and Food Control). The country currently mandates GS1 barcode identification for medicines and is building a national reporting model that requires supply chain actors to register products, submit batch information and maintain traceability records.

While Indonesia has not yet reached full real time serialization reporting like CIS or GCC countries, the system is moving in that direction. Importers and manufacturers must meet strict GS1 labeling and product registration standards to ensure market access.

Labelling Requirements 

Every sellable unit must include a GS1 barcode. Depending on product category, this can be:

  • GS1 DataMatrix
  • GS1 QR Code
  • GS1 Linear Barcode (transition categories)

Required encoded elements:

  • GTIN
  • Batch Number
  • Expiry Date
  • Serial Number (mandatory for certain regulated categories as serialization expands)

Human readable fields must match encoded values.

Cases and pallets must carry SSCC barcodes to support hierarchy and logistics.

Regulatory Timeline 

  • 2018 – GS1 barcode adoption announced across pharmaceutical sector.
  • 2019 to 2021 – Mandatory GTIN and barcode labeling across categories.
  • 2022 – Product and batch registration through BPOM e-Registry strengthened.
  • 2023 onward – Movement toward serialization for selected product classes.
  • Future Roadmap – Full serialized traceability and aggregation similar to global models.

Reporting Requirements 

Operation
Data to Report
When to Report
Product Registration
GTIN, product details
Before importing or manufacturing
Batch Submission
Batch, Expiry, Quantity
Before distribution
Serialization (Emerging)
GTIN, Serial, Batch, Expiry
Currently for select categories
Aggregation (Planned)
SSCC hierarchy
As system evolves
Shipment Dispatch
Sender, Receiver, Shipment data
Before distribution
Receiving
Shipment data
At warehouse receipt
Returns
Batch or serialized returns
When returned
Decommission
Quantity or serial status
For destruction or expiry

Note: Indonesia is transitioning to full serialization; scope expands annually.

Operational Timelines for Industry 

  1. Register products and GTINs with BPOM.
  1. Update artwork to include GS1 compliant barcodes.
  1. Submit batch-level information through BPOM before distribution.
  1. Begin serialization for applicable regulated categories.
  1. Prepare for SSCC-based aggregation as system evolves.
  1. Maintain accurate reporting for shipments, returns and write offs.

Reporting Hub

  • Indonesia’s reporting is managed through BPOM e-Track and e-Registration systems.
  • Manufacturers and importers must register products and batches before distribution.
  • API submission is being developed as part of the national track and trace roadmap.
  • Customs integration requires product registration to be complete before import release.

Aggregation Requirements 

  • Aggregation is not yet fully mandatory, but encouraged to support the evolving system.
  • SSCC case and pallet hierarchy will become important as serialization stages expand.
  • Early adoption helps avoid rework when full aggregation becomes required.

Common Errors to Avoid 

  • Using non GS1 barcodes or improper GTIN allocation.
  • Missing product registration before import.
  • Incorrect batch or expiry data in BPOM submissions.
  • Barcode print quality issues leading to scan failures.
  • Lack of SSCC structure for logistics operations.
  • Failure to track serialization readiness for expanding categories.

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