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

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Country-Specific 6

No, only pharmaceutical products intended for the local UAE market need to be reported to Tatmeen. Export products are exempt.
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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 10

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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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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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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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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Data synchronization keeps data consistent:

  • Between internal systems
  • With trading partners
  • With regulatory portals
  • Critical for EPCIS accuracy
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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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A transaction ID links business transactions:

  • Purchase order number
  • Invoice number
  • Delivery note number
  • Required in EPCIS transaction events
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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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EPCIS 4

EPCIS stands for Electronic Product Code Information Services. It is a GS1 standard for sharing event data between trading partners in the supply chain.

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EPCIS defines four event types:

  • ObjectEvent: Observation of objects (commissioning, shipping, receiving)
  • AggregationEvent: Parent-child relationships (packing/unpacking)
  • TransactionEvent: Links objects to business transactions
  • TransformationEvent: Input/output relationships (manufacturing)
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An ObjectEvent captures observations about objects at a point in time. Common uses:

  • Commissioning (serial number activation)
  • Shipping (products leaving a location)
  • Receiving (products arriving)
  • Dispensing (products given to patient)

Action types: ADD, OBSERVE, DELETE

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An AggregationEvent records parent-child relationships between containers and their contents:

  • ADD: Items packed into a container
  • DELETE: Items unpacked from a container
  • OBSERVE: Confirmation of aggregation

Essential for case and pallet tracking.

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