FAQs

Frequently Asked - Find answers to common questions about Track & Trace

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Filtering by: 🇸🇦 Saudi Arabia
Country-Specific 25

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

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Yes, all drugs are tracked including unregistered drugs and must be reported upon every step in the supply chain.
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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.
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No, the RSD system rejects duplicated license numbers or GLNs for multiple registrations. Each entity must have unique identifiers.
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Yes, it is mandatory to register each location independently and track operations between them.
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All medications will be added automatically in the system within two days of approval by SFDA.
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No, you cannot use the same serial number on drugs that have the same GTIN. Each serial must be unique per GTIN.
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Yes, all movement of drugs should be reported on the system until the drug is sold to the end consumer.
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RSD responds immediately in real time for all reporting submissions.
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Report after finishing all the processes inside the establishment. Batch reporting is acceptable.
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The company where the final batch release came from sends notifications to RSD.
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The manufacturer that prints the 2-D Barcode and completes the batch release process notifies RSD.
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You can notify the system about export operations outside KSA. However, in the meanwhile, it is optional.
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No, they are not exempt. All pharmaceutical products must be tracked regardless of distribution method.
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SFDA must be notified by submitting drug information. No other establishment can process stolen items in the system.
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If the samples are for marketing purposes, they are exempted from notifying in the RSD system.
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RSD events should be reported within 24 hours of occurrence. Key requirements:

  • Real-time or near-real-time preferred
  • Maximum 24-hour delay allowed
  • Late reporting may result in compliance issues
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Deactivate units intended for destruction, document the reason, and send to destruction companies without dispatching through RSD.
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Yes, the RSD system accepts scanning and reporting of batches for efficiency.
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ISD (Interface Specification Documents) is a technical document for each process of the RSD system, used for B2B integration.
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You can use the RSD system portals for notification (reporting) until your system is ready for B2B integration.
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CSV (COMMA DELIMITED) format is accepted for file uploads to RSD.
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Licensed 3PL establishments can register independently with RSD and conduct accept/dispatch operations.
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No, each licensed warehouse from SFDA should have their own GLN. Each location requires separate registration.
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No, the RSD system will not affect customs clearance operations. However, you must report after receiving shipments.
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