Azerbaijan Pharmaceutical Track and Trace System Compliance

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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

Azerbaijan operates a national pharmaceutical traceability system known as the Drug Tracking and Monitoring System (DTMS). The system is managed by the Analytical Expertise Center of the Ministry of Health and is designed to improve supply chain transparency, prevent counterfeit medicines, and ensure patient safety.

The system requires pharmaceutical products to be uniquely identified and tracked across the supply chain from manufacturer or importer to pharmacies and healthcare institutions. Serialization and electronic reporting of product movements allow regulators to monitor medicine circulation and investigate suspicious products.

Manufacturers, importers, distributors, and pharmacies must participate in the DTMS platform and report relevant supply chain operations.

Labelling Requirements 

Pharmaceutical products placed on the Azerbaijani market must carry a GS1 compliant 2D DataMatrix barcode on the secondary packaging.

The barcode must include the following data elements:

  • GTIN
  • Serial Number
  • Batch Number
  • Expiry Date

Each sellable pack must have a unique serial number generated during packaging.

The barcode enables individual pack identification and supports verification across the distribution chain.

Human readable information printed on the packaging must match the encoded barcode data.

Regulatory Timeline 

2017 – Development of the national pharmaceutical track and trace system begins.

2019 – Implementation of the Drug Tracking and Monitoring System initiated.

2020 – Serialization and electronic reporting requirements introduced for pharmaceutical products.

2021 onward – Expansion of system participation across manufacturers, importers, distributors, and pharmacies.

Reporting Requirements 

Operation
Data to Report
When to Report
Commission
GTIN, Serial Number, Batch, Expiry
During packaging before product release
Serialization Upload
Serialized pack information
Before product distribution in Azerbaijan
Import Reporting
Shipment data and serialized pack list
Before customs clearance
Shipping
Sender identifier, receiver identifier, serial numbers or shipment identifier
Before dispatch
Receiving
Serial numbers or shipment identifier
Upon receipt at warehouse
Distribution
Serialized pack data and transaction details
During supply chain transfers
Dispensing
Serial number verification and status update
When supplied to patient
Decommission
Serial number and status change
When product is destroyed or removed

Operational Timelines for Industry 

  • Generate unique serial numbers for each pharmaceutical pack during packaging operations.
  • Print GS1 compliant DataMatrix barcodes on the secondary packaging.
  • Upload serialization data to the Drug Tracking and Monitoring System before products enter the market.
  • Report shipment and receiving events when medicines move between supply chain partners.
  • Ensure pharmacies verify and update serial status when medicines are dispensed to patients.
  • Maintain traceability records to support regulatory inspections and product recalls.

Reporting Hub

The Drug Tracking and Monitoring System (DTMS) is the national reporting platform used to monitor pharmaceutical product movement.

The system is operated under the supervision of the Ministry of Health and the Analytical Expertise Center.

Manufacturers and importers upload serialized product information to the DTMS platform before medicines enter the market. Supply chain participants report shipment, receipt, and dispensing transactions to maintain full traceability of medicines throughout the distribution chain.

Electronic reporting is performed through integrated system interfaces or secure online portals.

Aggregation Requirements 

The Azerbaijani track and trace system supports packaging hierarchies to improve logistics and supply chain efficiency.

Manufacturers may create aggregation structures linking serialized packs to cases or pallets.

Logistics units may be identified using SSCC identifiers to enable shipment tracking and simplify warehouse operations.

Aggregation improves operational efficiency but the primary regulatory requirement remains pack level serialization and reporting.

Common Errors to Avoid 

  • Failure to upload serialized pack data before distributing medicines in Azerbaijan.
  • Mismatch between printed barcode data and serialization data uploaded to the system.
  • Duplicate serial numbers generated during packaging operations.
  • Incomplete reporting of shipment or receiving transactions.
  • Failure to update serial status after dispensing or product removal.
  • Poor barcode print quality that prevents reliable scanning during distribution.

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LSPedia didn’t just provide software; they ensured we were fully compliant. Anytime we had questions, the LSPedia team knew DSCSA inside and out and guided us step by step. That level of expertise made a huge difference during audits. Thanks to their expert team our audit was smooth and successful

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Lead Pharmacist, Pioneer Pharmacy Services

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EPCIS Data Encoder,Capital Wholesale Drug
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