🇸🇦Saudi Arabia Active

RSD Saudi Food and Drug Authority
Serialization Requirements
Level Required Identifier Type Description
Unit Required SGTIN Primary packaging serialization with GTIN-14, serial, lot, expiry
Reporting Obligations
Event Type Required Timing Description
Commissioning Required Before distribution Serial number generation reporting
Shipping Required At dispatch Dispatch goods to next GLN
Receiving Required Upon receipt Verify and accept GTIN/BATCH/QTY from supplier
Decommissioning Required Inactivate Unit Product Mark damaged, expired, or dispensed packs inactive
Technical Specifications
  • EpcisVersion: 1.2
  • DataFormat: XML
  • IntegrationMethod: API
  • BarcodeType: DataMatrix (GS1)
  • RequiredFields: GTIN-14, Serial Number, Batch/Lot, Expiry Date
Product Scope
  • Human pharmaceutical products
  • Non-Registered Products
Exempt Products
  • Free Medical Sample
Official Documents
View All
Guideline
IntegrationGuideDTTSV21
SFDA
Guideline
Drug Barcoding Specifications AR
SFDA
Circular
46108-TrackingDrug
SFDA
Circular
1561839096Registration Integration
SFDA
Key Deadlines
Phase 1 - Serialization Required
Mar 01, 2017
GTIN-14, serial, lot, expiry required for all human and veterinary products
Phase 2 - GLN Registration
Mar 01, 2018
Factory and warehouse locations must be registered via GLN
Phase 3 - Reporting Requirements
Jan 01, 2019
SFDA initiated reporting requirements for all manufacturers
Phase 4 - Aggregation Mandatory
Aug 20, 2020
Aggregation at carton and pallet level mandatory
RSD Model Change
Aug 05, 2024
RSD announced Deserialization(Batch/QTY/GTIN) in the middle operations
Common Questions
Browse All FAQs

RSD (Rassd) is Saudi Arabia's pharmaceutical track and trace system, operated by the Saudi Food and Drug Authority (SFDA).

It mandates serialization and EPCIS reporting for all pharmaceutical products in the Saudi market.

View Saudi Arabia regulations

Yes, all drugs are tracked including unregistered drugs and must be reported upon every step in the supply chain.

Registration is optional for foreign manufacturers. They must either register through their KSA scientific office or authorize an agent to manage their account via authorization form.

No, the RSD system rejects duplicated license numbers or GLNs for multiple registrations. Each entity must have unique identifiers.
Last updated: January 10, 2026