🇸🇦Saudi Arabia Active

RSD (Rassd) Saudi Food and Drug Authority
Serialization Requirements
Level Required Identifier Type Description
Unit Required SGTIN Primary packaging serialization with GTIN-14, serial, lot, expiry
Case/Bundle Required SSCC Secondary packaging aggregation with 18-digit SSCC
Pallet/Shipper Required SSCC Logistics unit aggregation with SSCC
Reporting Obligations
Event Type Required Timing Description
Commissioning Required Before export Serial number generation report
Aggregation Required Before shipment Hierarchy relationship report
Shipping Required At shipment Dispatch notification
Receiving Required Upon receipt Receipt confirmation
Decommissioning Required When applicable Product recall/destruction
Technical Requirements
EPCIS Version
v@Model.TechnicalRequirements.EpcisVersion
Data Format
XML
Integration Method
API
Barcode Type
DataMatrix (GS1)
Required Fields
GTIN-14 Serial Number Batch/Lot Expiry Date
Product Scope
  • Human pharmaceutical products
  • Veterinary pharmaceutical products
  • Biological products
  • Vaccines
  • Blood products
Official Documents
View All
Guideline
RSD User Manual
SFDA View
TechnicalSpec
SFDA Serialization Requirements
SFDA View
TechnicalSpec
RSD API Documentation
SFDA View
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
Oct 01, 2019
SSCC at carton and pallet level mandatory
Phase 5 - Full Aggregation
Aug 20, 2020
Updated aggregation deadline for medicines
Notes

RSD is one of the most mature track and trace systems globally. Over 1 billion supply chain operations recorded. Goal: fully serialized and traceable pharmaceutical supply chain by Vision 2030. SFDA license required for all participants. Integration testing mandatory before go-live.

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Last updated: December 25, 2024