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Frequently Asked - Find answers to common questions about Track & Trace
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Yes. All legally registered invoicing companies must enroll, sign a Participation Agreement, and pay required fees to support hub maintenance.
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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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Invoicing Companies and Marketing Authorization Holders must register with GS1. GLN and GCP information can be found using the GS1 Lookup Directory and GTIN Management site.
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Tatmeen became operational on December 13th, 2022, which was 18 months after the decree was issued on June 14, 2021.
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Yes, both registrations are required. BrandSync submission is mandated by the Medicines Barcoding and Serialization Guideline for product master information. NHRA-MVC tracks medicines from shipment through dispensing.
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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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The process involves 10 steps: obtaining a Company Prefix, assigning numbers, selecting printing processes, environments, barcode types, sizes, formatting, colors, placement, and building quality plans.
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Supply Chain Partners are organizations collaborating to move pharmaceuticals from manufacturer to consumer. This includes MAHs (Marketing Authorization Holders), Licensed Agents, 3PL companies, and dispensaries.
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Aggregation defines parent-child barcode relationships, allowing receivers to scan one code and understand complete shipment contents. Serialized GTINs are used at unit and case levels; SSCC applies to pallets.
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All medications will be added automatically in the system within two days of approval by SFDA.
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The decree applies to all supply chain participants that produce, transport, store, or dispense pharmaceutical products in the UAE.
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The registration process involves administrative registration and technical onboarding, including TEST hub connection and PRODUCTION hub go-live after demonstrating compliance.
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Use the GS1 Lookup Directory or consult your GS1 membership documentation for assigned GLN and GCP numbers.
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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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The Invoicing Company is the entity handling invoicing, which may be the manufacturer or a separate company managing pharmaceutical distribution.
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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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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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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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