Türkiye Pharmaceutical Track and Trace System (ITS) 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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Central repository

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

Summary

Türkiye operates one of the most advanced pharmaceutical track and trace systems in the world, known as the İlaç Takip Sistemi (ITS). The system is managed by the Turkish Medicines and Medical Devices Agency (TITCK) under the Ministry of Health.

The ITS platform provides full end to end traceability of pharmaceutical products from manufacturer or importer to the point of dispensing. Every medicine pack must be serialized and reported to the national system. All supply chain participants including manufacturers, importers, wholesalers, pharmacies, and hospitals must report product movements through the ITS system.

The system prevents counterfeit medicines, ensures supply chain transparency, and enables rapid product recalls and market monitoring.

Labelling Requirements 

All pharmaceutical products placed on the Turkish market must carry a GS1 compliant 2D DataMatrix barcode on the secondary packaging.

The barcode must contain the following data elements:

  • GTIN
  • Serial Number
  • Batch Number
  • Expiry Date

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

The DataMatrix barcode must be printed in accordance with GS1 standards and must be readable throughout the supply chain.

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

Regulatory Timeline 

2007 – Türkiye begins development of the national pharmaceutical track and trace system.

2010 – ITS officially launched and serialization becomes mandatory for pharmaceutical products.

2012 – Full supply chain reporting implemented including wholesalers and pharmacies.

2014 onward – Continuous system enhancements introduced to improve verification, recall management, and supply chain monitoring.

Reporting Requirements 

UAE Serialization Table
Operation
Data to Report
When to Report
Commission
GTIN, Serial Number, Batch, Expiry
During packaging before product release
Import Notification
Serialized pack data and shipment details
Before import clearance
Aggregation
Parent package identifier and child serial numbers
When creating logistics hierarchy
Shipping
Sender GLN, Receiver GLN, serial numbers or SSCC
Before shipment
Receiving
Serial numbers or SSCC with receiving entity identifier
Upon warehouse receipt
Dispensing
Serial number and dispensing information
At pharmacy or hospital supply to patient
Returns
Serial number and transaction reference
When products are returned
Decommission
Serial number and reason code
When product is destroyed or removed from supply chain

All events must be reported electronically through ITS integration.

Operational Timelines for Industry 

  • Generate unique serial numbers for each pharmaceutical pack during packaging operations.
  • Print GS1 compliant DataMatrix barcodes on the secondary packaging.
  • Report commissioning data to ITS before products enter the Turkish market.
  • Report import transactions for imported medicines before customs clearance.
  • Report shipping and receiving events when products move between supply chain partners.
  • Ensure pharmacies report dispensing transactions when medicines are supplied to patients.
  • Submit return and decommission transactions when products are removed from the supply chain.

Reporting Hub

The İlaç Takip Sistemi (ITS) is the national reporting hub operated by the Turkish Medicines and Medical Devices Agency.

All serialization and product movement data must be reported to ITS through web services or integrated system connections.

The system records the complete lifecycle of each pharmaceutical package including production, import, distribution, dispensing, and decommissioning.

Every supply chain participant must maintain an active ITS account and system integration to report required transactions.

Aggregation Requirements 

Aggregation is supported within the ITS system to improve supply chain efficiency and shipment management.

Manufacturers may create packaging hierarchies linking individual serialized packs to cases or pallets. Logistics units may use SSCC identifiers to manage aggregated shipments.

Aggregation information can be reported to ITS to enable efficient tracking and verification of logistics units during distribution.

Common Errors to Avoid 

  • Failure to report commissioning data before releasing products to the market.
  • Mismatch between printed barcode data and serialization data reported to ITS.
  • Duplicate serial numbers generated during packaging operations.
  • Incomplete reporting of shipment and receiving transactions.
  • Failure to report dispensing events at pharmacies or hospitals.
  • Barcode quality issues that prevent 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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