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Frequently Asked - Find answers to common questions about Track & Trace

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Country-Specific 20

Yes, all invoicing companies (MAHs/manufacturers), agents/distributors, and dispensers must register with NHRA-MVC. MAHs require proof of drug registration in the DUR, a Global Location Number, and a Company Prefix from GS1.
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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

View Jordan regulations

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The decision to conduct a pilot drug labeling project was made in December 2018. And since September 2019, it has been launched, for which methodological

recommendations for this procedure were approved, a list of participants in the pilot project and medicines subject to labeling within its framework was determined.

At the same time, in October 2020, by order of the Prime Minister, a comprehensive plan for the development of the pharmaceutical and medical industry for 2020–

2025 was approved, which also includes issues of labeling medicines. As for the pilot project, it was completed on July 31, 2021. According to the Kazakhstan Pharmaceutical Bulletin, 23 representatives of the pharmaceutical industry, including manufacturers, distributors, pharmacy and medical organizations, took part in the pilot. Based on the results of the pilot project, recommendations were sent to improve the marking and traceability information system. The first stage of mandatory labeling of 90 types of medicines began on July 1, 2022,

of which more than 80% of medicines are produced by 4 domestic manufacturers. A number of domestic manufacturers managed to purchase equipment for marking, joined the IS MPT, but not all market participants are ready to fully implement the project. Taking into account the risks of reducing the availability of medicines, the

insufficient readiness of the information system, due to the lack of integration of the information system for labeling and traceability of goods, the Ministry of Health of the

Republic of Kazakhstan has developed amendments that suspend the mandatory labeling and traceability of medicines until July 1, 2024.


The following sequence is currently defined:

 from July 1, 2024 (stage 2) - drugs purchased by the Single Distributor (about 40%);

 from January 1, 2025 (stage 3) - prescription drugs (about 30%);

 from July 1, 2025 (stage 4) - over-the-counter drugs (about 30%)

Full traceability will be implemented from July 1, 2025.

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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.

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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.


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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.

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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.


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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.

View UAE regulations

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The 3PL records aggregation, shipping, and receiving using its GLN.

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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.

View Saudi Arabia regulations

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NHRA-MVC (Medicine Verification Center) is Bahrain's pharmaceutical track and trace system, operated by the National Health Regulatory Authority (NHRA).

View Bahrain regulations

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Pharmacies must stop the sale of any unit with an unverified or invalid code and report it immediately to the EDA.

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Yes, registration is required per the Pharmaceutical Products Traceability Directive No 43/2019 and related directives issued by EFDA.
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Expired products are reported as a “Decommission Event.”

Example: Batch B123 expired Dec 2026 → all serials from B123 marked “Decommissioned – Expired.”

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Yes, via the T&T portal, but ERP integration automates reporting.

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 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.

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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).


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Yes. 3PLs within Egypt must register GLNs and are responsible for reporting aggregation, shipping, and receiving events from their facilities. Regional Hubs outside Egypt need not register with GLN. Brand owners remain accountable to EDA for ensuring 3PL compliance.

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Each carton/pallet is assigned an SSCC (Serial Shipping Container Code, AI 00).

All child Serials inside are digitally linked to the SSCC.

Example:

• SSCC: 00312345678901234567

• Contains Serials: SN000000123456 → SN000000123475

System mapping: SSCC 0031234567890123

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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.

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