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Frequently Asked - Find answers to common questions about Track & Trace
Country-Specific 20
Aggregation is the process of linking individual packs (child) to a larger shipping unit (parent), such as a carton or pallet. This larger unit is assigned a Serial Shipping Container Code (SSCC), allowing the entire shipment to be tracked through the supply chain without scanning every individual box at every stop.
If an entity fails to comply with the tracking requirements, the EDA may :
- Issue a formal written warning.
- Temporarily suspend the circulation of the violating product.
- Temporarily stop supplying products to the violating entity.
- Impose financial penalties.
TATMEEN is the UAE's national pharmaceutical track and trace system, operated by the Ministry of Health and Prevention (MoHAP).
It requires manufacturers and importers to serialize products and report EPCIS events throughout the supply chain.
RSD (Rassd) is Saudi Arabia's pharmaceutical track and trace system, operated by the Saudi Food and Drug Authority (SFDA).
It mandates serialization and EPCIS reporting for all pharmaceutical products in the Saudi market.
NHRA-MVC (Medicine Verification Center) is Bahrain's pharmaceutical track and trace system, operated by the National Health Regulatory Authority (NHRA).
Jordan's serialization requirements are managed by the Jordan Food and Drug Administration (JFDA):
- Unit-level serialization with DataMatrix barcode
- GTIN, serial number, batch, and expiry encoding
- EPCIS event reporting
- Focus on high-risk and imported products initially
The system includes "Error Declaration" events for almost every action (e.g., Commission Error, Shipping Void, Receiving Error Declaration). These allow users to cancel a previously reported transaction and correct the data record.
Yes. All entities (factories, distributors, pharmacies, and hospitals) must acquire 2D Scanners capable of reading Data Matrix codes and decoding them for the system.
Not necessarily, but their existing systems (like ERP, MES, or WMS) must be capable of integrating with the National System using the EPCIS protocol. They must be able to generate and send data files in XML/EPCIS format.
The system tracks "exits" through several specific event types:
- Dispensing: When a pharmacy or hospital gives the medicine to a patient.
- Destruction: Used to report packs that are damaged or expired and must be disposed of.
- Sampling: When packs are pulled from a batch for quality testing or research.
- Stolen/Missing: To report units that are lost or involve criminal activity.
This event is recorded when a larger shipping unit (like a pallet or big crate) is opened to separate the individual boxes for independent distribution or sale.
Distributors and warehouses must scan and register the receipt of a shipment within a maximum of 48 hours from the actual physical delivery. Failure to do so triggers a regulatory alert.
Yes, the following are currently excluded :
- Unregistered imported products requested for specific individuals/entities.
- Products for clinical trials.
- Free medical samples intended for research or medical promotion.
Pharmacies must stop the sale of any unit with an unverified or invalid code and report it immediately to the EDA.
The pharmacist must scan the 2D Data Matrix on the outer box for every partial sale until the last unit is gone. Consequently, the pharmacy must keep the original outer packaging until the very last dose is dispensed to ensure the code remains available for scanning.
The entity must record a "Return" event on the system. If the return involves products previously marked for export, it must specifically be labeled as "from Export" to maintain a clear history of the pack's location.
Manufacturers are responsible for the "birth" of the data through several key steps:
- Commissioning: Reporting the creation of the unique Product Code and Serial Number.
- Packing (Aggregation): Linking individual packs into larger units (cartons/pallets) using an SSCC code.
- Shipping: Recording the movement of these units to the next point in the chain.