The UAE’s Ministry of Health and Prevention – MoHAP has published legislation that defines the Serialisation and Track and Trace (T&T) requirements for all participants involved in manufacturing, distributing, and dispensing pharmaceutical products.
This legislation is driven by the need to maintain and improve patient safety whilst at the same time reducing counterfeits within the UAE.
Tatmeen is the Information Technology (IT) regulatory system that will support the UAE T&T legislation for the pharmaceutical industry. All products placed on the UAE market need to display a serialized unique identifier on the product secondary packaging. Also aggregated packaging (aggregated homogenous products or logistics units) must display a serialized unique identifier. The appropriate serialized identifiers must be used to record the operational and transactional movements of the products throughout the supply chain and during dispensing to the patient/consumer.
The deadline of the 6-month grace period is here. After 13th December all pharmaceutical products imported into the UAE must comply with the decree by applying a 2D matrix barcode and human-readable format, by following GS1 standards.
SoftGroup developed a fully Track & Trace solution in compliance with all Tatmeen requirements – SoftGroup® SaTT UAE Solution.
SoftGroup® SaTT UAE Hub Gateway provides a connection and data exchange between UAE National Track & Trace System – Tatmeen digital platform and all supply chain actors (MAHs, Manufacturers, Licensed Agent, Brand Owners, Wholesalers, Distributors, etc.). The solution will allow access to the product master data (PMD) of imported or produced drugs and uploading and publishing the product pack data (PPD), including serial and aggregation reports of all packaging levels.
The system will support all possible statuses and functionality, required by the UAE Ministry of Health and Prevention (“MOHAP”).The system supports all possible statuses and functionality, required by UAE Ministry of Health and Prevention (“MOHAP”).
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