Saudi Arabia DTTS 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

Saudi Arabia mandates end to end pharmaceutical traceability through the Drug Track and Trace System (DTTS) operated by the Saudi Food and Drug Authority (SFDA). All human medicines distributed in the Kingdom must be serialized, aggregated and reported across every supply chain step. The system aims to ensure patient safety, remove counterfeit products and give regulators visibility from production to final dispensing.

Manufacturers, importers, wholesalers and pharmacies must report all operations in near real time to remain compliant and avoid shipment delays.

Labelling Requirements 

A GS1 2D DataMatrix must be printed on each sellable unit with:

  • GTIN
  • Serial Number
  • Batch Number
  • Expiry Date

Human readable fields must match the encoded data.

Shippers and pallets must carry SSCC barcodes to support aggregation.

Arabic labeling rules apply to outer packages and supplied materials.

Regulatory Timeline 

  • 2017 – SFDA announces national serialization program.
  • 2019 March – Serialization becomes mandatory for all human medicines.
  • 2020 – Aggregation becomes required for movement reporting.
  • 2021 onward – Full DTTS reporting enforcement across manufacturers, importers and distributors.

Reporting Requirements 

Operation
Data to Report
When to Report
Commission
GTIN, Serial, Batch, Expiry
At the time of packaging
Aggregation
Parent SSCC, Child Serials
When forming bundles, cases and pallets
Shipment Dispatch
Sender GLN, Receiver GLN, SSCC or Serial List
Before goods leave the facility
Shipment Receipt
SSCC or Serial List, Receiver GLN
At arrival
Import Clearance
Shipment details + serials
Before customs release
Sale or Distribution
Serial list
At movement to pharmacy or hospital
Returns
Serial status
When returned
Recall Actions
Affected serials
When triggered
Decommission
Serial and reason
When destroyed, expired or removed

Operational Timelines for Industry 

  1. Complete SFDA DTTS onboarding, GLN setup and system integration.
  1. Configure GTINs and print serialized DataMatrix during packaging.
  1. Build full aggregation hierarchy with valid SSCCs.
  1. Report commission, aggregation and shipment data before dispatch.
  1. Link import shipments to DTTS for customs clearance.
  1. Report distribution, supply and return events in near real time.
  1. Submit decommission and destruction events as required.

Reporting Hub

  • Saudi Arabia uses the SFDA DTTS platform for all track and trace reporting.
  • Reporting is done through DTTS APIs or the DTTS portal.
  • Each entity must maintain active integration credentials.
  • Importers must link shipments to the Saudi Customs system for clearance.

Aggregation Requirements 

  • Aggregation is mandatory in Saudi Arabia.
  • Every case and pallet must have a complete parent child hierarchy.
  • Shipments without aggregation often fail clearance or produce mismatches.
  • Reuse of SSCCs is not allowed.

Common Errors to Avoid 

  • Missing SSCC hierarchy for cases and pallets,
  • Wrong manufacturer, importer or distributor GLN.
  • Serial mismatch between physical label and reported message.
  • Attempting to reuse SSCCs.
  • Late reporting causing delays at SFDA or customs.
  • Incomplete handling of returned or recalled serials.

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Smooth and Successful

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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LSPedia shows a constant commitment to improvement; whether it's their support or their product...they're always leveling up. The support team provides consistently thorough follow-up and clear, articulate communication. the support we receive represents a meaningful step up in service and is genuinely appreciated.

Zac Sweeny
EPCIS Data Encoder,Capital Wholesale Drug
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