UAE
| Regulatory Agency | Ministry of Health and Prevention, UAE (MoHAP) |
| Regulation Name | Tatmeen – Pharmaceutical Products Traceability (Ministerial Decree No. 73 of 2021) |
| Compliance Dates |
|
| Applies to | All conventional pharmaceutical products sold, imported, distributed, or stored in the UAE (registered & unregistered) |
(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)
| Barcode Symbology | GS1 DataMatrix (2D) per GS1 global standards |
| Barcode Content | Encoding Options
|
| Serial Number Randomization | Yes — randomized at unit level, typical GS1 practice is high entropy (e.g., 1:10,000), random sequence for each serialized unique identifier |
| Serial Number Reuse | Not explicitly defined in publicly available guides — best practice from GS1 is no reuse within defined portfolio and lifetime of product. Not specified whether UAE explicitly allows reuse; assume adherence to GS1 best practice (no reuse) unless guidance states otherwise. |
| Human Readable Expiry Date Format | Expiry date printed also in human-readable form. Format commonly recognized under GS1 is YYMMDD. |
| Barcode Data Encoding | GS1 AIDC DataMatrix encoding with proper application identifiers (AIs) per GS1 General Specifications |
| Product Code Notes | 2D DataMatrix must contain all four data elements in one symbol. If linear barcode is also present, it must encode same GTIN. |
| Free Samples must be marked? | Exempt: Free samples do not require serialization (excluded from mandate) |
(A shipper containing one or more secondary packs)
| Barcode Symbology | GS1-128 Linear Barcode for logistic units & SSCC | |
| Barcode Contents | SSCC (Serial Shipping Container Code); optionally GTIN if treated as trade item by brand owner | |
| Parent-Child Mapping Aggregation Capture? | Yes — manufacturers aggregate smaller units into logistic units using SSCC codes; downstream repackers also add SSCC aggregation for reconfigured units. |
| Send Unit Data to Government Repository? | Yes — serialized unit data must be reported to the Tatmeen traceability platform. |
| Send Unit Data to Third-Party Repository? | Optional — for internal systems or supply chain partners (not mandated by MoHAP). |
| Send Unit Data to Trading Partner? | Often done via EPCIS or partner systems; not strictly mandated by regulation, but common industry practice. |
| Send Aggregation Data to Government Repository? | Yes — aggregation events must be captured and reported to Tatmeen. |
| Send Aggregation Data to Third-Party Repository? | Optional — depends on third-party service agreements. |
| Send Aggregation Data to Trading Partner? | Industry practice encourages sharing via EPCIS; not compulsory by MoHAP text. |
| Who Offers Data Repository for Authentication? | Tatmeen platform (MoHAP digital traceability system); may interface with BrandSync or other GS1 data pools for master data |
| Manufacturers Must Register Shipments in Repository? | Yes — all products must be linked to Tatmeen before importation or distribution. |
| Downstream Trading Partners Must Authenticate on Receipt? | Stakeholders (distributors, pharmacy, healthcare facilities) must scan & capture serialized data for traceability; authentication is expected. |
| Downstream Trading Partners Must Authenticate on Shipment? | Yes — reporting of movement events in Tatmeen or internal archive is industry standard; specific MoHAP requirements mandate event capture. |
| Manufacturer Activity Reported? | Yes — serialization and aggregation events reported. |
| Downstream Trading Partner Activity Reported? | Yes — downstream scanning events (receipt, shipment, dispensing) feed traceability. |
Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.
Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.
Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.
For Further Information, please contact our Compliance Team at info@kevision.in
