Tatmeen (Ministerial Decree No. 73 of 2021 on Pharmaceutical Products Traceability)
Serialization status
Active since December 13, 2022; live traceability enforced
Country population
10 million
Alert management: Centralized through Tatmeen platform; supports recalls, status changes, exception events (lost, damaged, stolen)
Aggregation requirement: Mandatory
Track & Trace requirement: Comprehensive EPCIS event reporting for serialization, commissioning, shipment, receipt, sampling, aggregation, dispensing, destruction, etc., immediately after each event
Official governing body: UAE Ministry of Health and Prevention (MoHAP) manages Tatmeen
Implementation deadline / enforcement date: Legislation: June 14, 2021. Operational: December 13,2022
Serialization type / level: GS1 DataMatrix: GTIN + SN + EXP + LOT
MAH / CMO responsibilities: MAH or licensed agent transmits commissioning data; manufacturers/CMOs handle serialization and aggregation; distributors and dispensers report movement and decommissioning events.
Serialized product scope: All imported and locally manufactured Rx, OTC, biologicals, and unregistered medicines must be serialized.
Penalties for non-compliance: Non-compliant shipments may be rejected by customs, with possible fines or registration delays.
Repackaging rules: Repackaged products must be re-aggregated with new SSCCs and reported to Tatmeen.
Serialization exemption rules: Exemptions apply to free samples, personal-use imports, medical devices, and GSL products.
Market coding requirements:
GS1-based 2D DataMatrix on secondary packaging, encoding GTIN + randomized Serial Number + Expiry + Batch/Lot
