FAQs answered for you.
Frequently Asked - Find answers to common questions about Track & Trace
Country-Specific 20
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.
When the Data Matrix of a pack intended for a foreign market is scanned, the system does not reject
the operation but starts an automatic procedure called Intermarket Transaction (IMT).
The verification flow has the following steps:
1. Local check: the local NMVS carries out an initial check in its own database.
2. Forwarding to the EU Hub: as it does not find the serial number data in its own repository, the
NMVS forwards the verification request to the EU Hub.
3. Identification of the competent country: the EU Hub identifies the relevant National System
(in this case the Spanish one) and forwards the request to it.
4. Verification and reply: the destination NMVS checks in its own repositories whether the
unique identifier exists and what its status is (for example “Active”). The result is sent to the
EU Hub, which redirects it to the local NMVS to confirm the operation to the user.
5. Synchronisation: finally, the status is updated in the national repositories involved.
In an Intermarket Transaction, the NMVS does not return the product master data; in addition, the
reply contains the notification NMVS_NOTIFY_IMT_01.
The system is mandatory for all entities in the Egyptian pharmaceutical market, including :
- Local manufacturers and importers.
- Distributors and licensed warehouses.
- Public and private pharmacies.
- Governmental, university, and private hospitals.
- Logistics service providers (3PL).
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
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.
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.
Only if current ones can’t read 2D Data Matrix codes.
The reporting model will be vertical, with all traceability events reported directly to the national hub. At this stage, no requirements have been defined for partner-to-partner data sharing.
The EDA Unified National Track & Trace Platform will follow a centralized model, requiring all traceability events to be reported directly to the national hub
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.
To facilitate manual verification in case of optical reading problems, the key information of the Data Matrix code is printed in textual format on the packaging:
- PC → Product Code (GTIN)
- SN → Serial Number
- LOTTO → Batch Number
- SCAD → Expiration Date
- AIC → National reimbursement number
These pieces of information are preferably positioned near the two-dimensional barcode to facilitate reading.
The HRI information must be printed as indicated in the “Data Matrix” Decree (Ministry of Health Decree of March 6, 2025, Annex A – point 6).
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 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.
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.
Integration is via GS1 EPCIS standards. Data can be transmitted using secure APIs or file exchanges in XML/JSON/CSV formats. Detailed technical specifications and API documentation are provided during company onboarding. A dedicated company Technical Helpdesk is available to support manufacturers and importers during integration.
The manufacturer or importer initiates a “Recall Event.” All affected serials are blocked. Pharmacies scanning them will receive “Invalid – Recalled.”
The receiving site scans the SSCC or serials. The system logs the “Receiving Event.”
Example: Distributor scans SSCC 00312345678901234567. System updates all child serials to status “Received.” If not scanned within 48 hours, a compliance alert is triggered.
Pharmacists or hospital staff scan the serials before giving it to the patient. The system verifies validity and records a “Dispense Event.”
Example: serial SN000000123456 → status updated to “Dispensed.”