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Frequently Asked - Find answers to common questions about Track & Trace
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Country-Specific 20
The EDA (Egyptian Drug Authority) is Egypt's regulatory body responsible for:
- Drug registration and approval
- Pharmaceutical quality control
- Track and trace system (EPTTS)
- Import/export control
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NHRA (National Health Regulatory Authority) is Bahrain's healthcare regulatory body responsible for:
- Medicine and medical device regulation
- Healthcare facility licensing
- Track and trace compliance
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JFDA (Jordan Food and Drug Administration) is the regulatory authority responsible for:
- Food and drug safety
- Product registration
- Track and trace requirements
- Import/export control
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Tatmeen applies to Conventional and Biological Medicines in the first phase. Other product categories will follow in subsequent phases.
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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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Aggregation defines parent-child barcode relationships, allowing receivers to scan one code for complete shipment details at case and pallet levels.
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The Invoicing Company is the entity handling invoicing, which may be the manufacturer or a separate company managing pharmaceutical distribution.
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Yes, barcodes apply to both registered and unregistered drugs that are distributed in the UAE.
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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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Both secondary (case/shipper) and tertiary (pallet) packaging require serialization. SGTIN for units/cases and SSCC for pallets.
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Yes, all legally registered Invoicing Companies must be EFDA-approved, complete signup, sign participation agreements, and pay required fees.
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No special software is required. Companies can use a web browser, mobile app, or connect their ERP/WMS systems via B2B API integration.
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RSD responds immediately in real time for all reporting submissions.
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Registration involves two stages: first connecting to the TEST hub with formatted data files, then to PRODUCTION for operations once certified.
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Complete MAH approval with EFDA, register with GS1, obtain GLN and GTIN, visit EFDA-MVC portal, complete the application form, finalize participation agreement, then begin technical onboarding.
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First obtain a GLN from GS1. Once received, Tatmeen will release a registration link. The SPOC (Single Point of Contact) completes the initial registration and becomes administrator for the business location.
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Report after finishing all the processes inside the establishment. Batch reporting is acceptable.
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The Invoicing Company is the entity handling invoicing - either the manufacturer or a separate company managing billing for pharmaceutical shipments.
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Yes. Registration and obtaining a unique Global Location Number (GLN) is mandatory for all sites licensed to produce, store, and dispense drugs in the UAE.
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The company where the final batch release came from sends notifications to RSD.
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