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Frequently Asked - Find answers to common questions about Track & Trace
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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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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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Yes, all legally registered Invoicing Companies must be EFDA-approved, complete signup, sign participation agreements, and pay required fees.
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Yes, barcodes apply to both registered and unregistered drugs that are distributed in the UAE.
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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 movement of drugs should be reported on the system until the drug is sold to the end consumer.
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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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RSD responds immediately in real time for all reporting submissions.
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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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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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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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The company where the final batch release came from sends notifications to RSD.
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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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Products and product information cannot be uploaded to Tatmeen directly. They need to be uploaded to BrandSync, which synchronizes with Tatmeen.
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The manufacturer that prints the 2-D Barcode and completes the batch release process notifies RSD.
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Yes, 3PL companies must register with GS1 and obtain a GLN despite not registering with the ministry. They play a crucial role in the supply chain.
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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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