Skip links

Saudi Arabia Regulatory

Saudi Arabia Regulatory Requirements

 
Regulatory Agency Saudi Food & Drug Authority (SFDA) – national medicines regulator and operator of the national Drug Track & Trace System (RSD).
Regulation Name
  • SFDA Drug Track & Trace System (RSD – “Rasd”)
  • SFDA Serialization & Barcoding Implementation Guidelines (Human Drugs)
Compliance Dates
  • March 2018 – Serialization mandatory for all registered human pharmaceutical products.
  • Aggregation and reporting requirements phased in subsequently. (Full implementation now mandatory for all marketed human medicines.)
Applies to
  • All human pharmaceutical products (prescription and OTC) manufactured in or imported into Saudi Arabia.
  • Applies to manufacturers, MAHs, importers, distributors, and pharmacies.

Secondary Packaging

 
Barcode Symbology GS1 2D DataMatrix
Barcode Content
  • GTIN (AI 01), Serial Number (AI 21), Expiry Date (AI 17), Batch/Lot (AI 10)
Serial Number Randomization Yes – randomized and unique per pack
Serial Number Reuse Not permitted
Human Readable Expiry Date Format Typically MM/YYYY or YYYY-MM-DD (must match encoded AI 17)
Barcode Data Encoding GS1 Application Identifiers (01, 17, 10, 21)
Product Code Notes GTIN required; must be registered with GS1 and linked to SFDA product registration
Free Samples must be marked? Yes – must comply with serialization and labeling requirements if distributed

Tertiary Packaging

 
Barcode Symbology GS1-128 (SSCC) and/or GS1 DataMatrix for aggregated cases
Barcode Contents SSCC (AI 00) and aggregation hierarchy data

Aggregation Data Capture

 
Parent-Child Mapping Aggregation Capture? Yes

Data Exchange

 
Send Unit Data to Government Repository? Yes – All serialized packs must be reported to SFDA RSD system
Send Unit Data to Third-Party Repository? Optional (internal use), not regulator-mandated
Send Unit Data to Trading Partner? Commercial exchange expected between partners
Send Aggregation Data to Government Repository? Yes – aggregation hierarchy reporting required
Send Aggregation Data to Third-Party Repository? Optional
Send Aggregation Data to Trading Partner? Commercially expected.

Authentication

 
Who Offers Data Repository for Authentication? SFDA RSD (Rasd) national repository
Manufacturers Must Register Shipments in Repository? Yes – commissioning, shipping, decommissioning events must be reported
Downstream Trading Partners Must Authenticate on Receipt? Yes – distributors and pharmacies scan and report receipt events.
Downstream Trading Partners Must Authenticate on Shipment? Yes – shipping/transfer events must be reported
Manufacturer Activity Reported? Yes
Downstream Trading Partner Activity Reported? Yes
Source and Credit: This information is fully or partly based on the GS1 master document (all rights reserved). As GS1 does not control the content of the information, GS1 shall not be held liable, under any circumstance, if it differs from the master document.

Disclaimer

This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just a possible interpretation of information available in the public domain and that interpretation is subject to change. This information does not constitute legal advice.

About Kevision Systems

Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.

Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.

Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.

For Further Information, please contact our Compliance Team at info@kevision.in

Explore
Drag