UAE Tatmeen 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

The United Arab Emirates operates a national pharmaceutical traceability system called Tatmeen. All human medicines imported or sold in the UAE must carry GS1 compliant DataMatrix barcodes and must be reported across the full supply chain. Tatmeen aims to improve patient safety, reduce counterfeit risks and give regulators full visibility of product movement.

Manufacturers and importers must serialize, aggregate and report all operations in near real time to avoid delays at customs and ensure uninterrupted supply.

Labelling Requirements 

Every sellable pack must carry a GS1 2D Data Matrix with: 

  • GTIN 
  • Serial Number 
  • Batch Number 
  • Expiry Date 

Human readable data must match the barcode. 

Case and pallet SSCC barcodes are required to support aggregation. 

Regulatory Timeline 

  • 2021 – Tatmeen announced as national track and trace system.
  • 2022 June – Serialization mandatory for all human medicines.
  • 2022 December – Aggregation and full movement reporting become mandatory.
  • 2023 onward – Strict enforcement at import and distribution checkpoints.

Reporting Requirements 

Operation
Data to Report
When to Report
Commission
GTIN, Serial, Batch, Expiry
During packaging before shipment
Aggregation
Parent SSCC, Child Serials
When creating cases or pallets
Shipping
Sender GLN, Receiver GLN, SSCC or Serial List
Before dispatch
Receiving
SSCC or Serial List, Receiver GLN
At warehouse receipt
Import Clearance
Shipment data and serial list
Before customs release
Supply to Pharmacy
Serial list
At supply point
Returns
Serial status and reference
When return is approved
Decommission
Reason and serials
When product is destroyed or removed

Operational Timelines for Industry 

  1. Complete Tatmeen onboarding and GLN setup before production. 
  2. Print serialized DataMatrix during packaging. 
  3. Build SSCC case and pallet hierarchies. 
  4. Report commission, aggregation and shipping before dispatch. 
  5. Complete import reporting and clearance in Tatmeen. 
  6. Report receiving and supply operations in near real time. 
  7. Submit decommission and return events as they occur. 

Reporting Hub

  • Reporting is done to Tatmeen, operated by EVOTEQ for the Ministry of Health.
  • All supply chain actors must maintain active Tatmeen accounts and API credentials.
  • Reporting is supported through APIs or manual upload.

Aggregation Requirements 

  • Aggregation became enforceable in December 2022 as part of full supply chain reporting.
  • SSCC level hierarchy is required for accurate tracking and customs clearance.
  • Shipments without valid aggregation often fail or face delays.

Common Errors to Avoid 

  • Use of wrong GLN for manufacturer, CMO or importer.
  • Serial mismatch between printed and reported data.
  • Missing parent child hierarchy for aggregated shipments.
  • Reuse of SSCCs.
  • Reporting with expired Tatmeen credentials.

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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

Hussein Salman
Lead Pharmacist, Pioneer Pharmacy Services

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Zac Sweeny
EPCIS Data Encoder,Capital Wholesale Drug

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