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Frequently Asked - Find answers to common questions about Track & Trace
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Country-Specific 11
Yes, if the Licensed Agent GLN is associated with the product in the ministry's master data, they can handle commissioning.
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CSV (COMMA DELIMITED) format is accepted for file uploads to RSD.
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No. 3PL companies are not allowed to register products under their name. They handle receiving, shipping, and other logistics operations only.
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Licensed 3PL establishments can register independently with RSD and conduct accept/dispatch operations.
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No, only pharmaceutical products intended for the local UAE market need to be reported to Tatmeen. Export products are exempt.
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No, each licensed warehouse from SFDA should have their own GLN. Each location requires separate registration.
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Products need to be commissioned to Tatmeen prior to the import customs clearance into the UAE local market.
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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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Products will have their status changed to Decommissioned - Dispensed and will be automatically decommissioned from Tatmeen.
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Yes, for Conventional and Biological Medicines, free samples must be reported, except in certain cases defined in the guidelines.
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Product verification is a process used to confirm that a product is genuine and authentic, showing its status and hierarchy information.
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Data 9
Master data is reference information:
- Product data (GTIN, description)
- Location data (GLN, address)
- Trading partner data
- Must be synchronized across systems
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A verification response confirms product authenticity:
- GTIN + Serial + Lot + Expiry verified
- Response: Valid/Invalid/Unknown
- Required at point of dispense
- Real-time query to repository
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Lot number: Identifies production batch (many units share same lot)
Serial number: Unique identifier for each unit
- Both required for full traceability
- Lot = quality tracking
- Serial = individual tracking
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Data synchronization keeps data consistent:
- Between internal systems
- With trading partners
- With regulatory portals
- Critical for EPCIS accuracy
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Key difference:
- Master data: Static reference data (product info, locations)
- Event data: Dynamic transaction records (what, when, where, why)
Both needed for complete traceability.
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Batch traceability tracks products by production batch:
- Same lot number = same production run
- Enables batch-level recalls
- Links to quality records
- Part of GMP requirements
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Exception handling manages serialization issues:
- Rejected units on line
- Failed submissions to portal
- Verification failures
- Data discrepancies
Requires documented procedures.
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Data retention requirements:
- Keep records for specified period
- Typically 1 year after expiry + buffer
- Country-specific requirements
- Must be retrievable for audits
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Compliance reports demonstrate regulatory adherence:
- Serialization status by product
- Event submission statistics
- Error rates and resolution
- Required for audits
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