[Blog] Tatmeen Traceability System – UAE’s Track & Trace solution for Pharmaceuticals
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UAE`s Ministry of Health and Prevention (MOHAP) announced the establishment of the first traceability solution for the pharma industry – the Tatmeen.
In the middle of 2021, in Ministerial Decree No. 73, the Ministry of Health and Prevention (MOHAP) announced the establishment of the first traceability solution for the pharma industry – the Tatmeen platform. MOHAP, in partnership with Dubai Health Authority (DHA) and EVOTEQ, is developing the GS1-based platform, enabling the traceability of pharma products across the supply chain.
The Tatmeen`s benefits are the familiar ones – fight drug counterfeiting, ensure secure healthcare, enhance visibility, real-time monitoring across the supply chain, recall management.
Objectives
Product Security
- Ensure traceability; detect counterfeited drugs; avoid reimbursement fraud; fast product recalls and withdrawals
Patient Safety
- Minimize the risk of errors; prediction
Supply Chain Management
- Forecast shortages; real-time and secure exchange of data
Regulatory requirements
Regarding serialization requirements, the product must be labelled with four data points in a GS1 Data Matrix code:
GTIN (Global Trade Item Number)
Randomized serial number – up to 20 characters
Expiry date – YYMMDD format
Batch/ lot number
As for aggregation, the manufacturer is responsible for labelling all logistic units with GS1-128 barcodes encoded with SSCC (Serial Shipping Container Code).
The exemptions
Products that are exempt from serialization are:
- Free samples of pharmaceutical products;
- Pharmaceutical products imported for personal use only;
- Medical devices and supplies; and
- GSL products.
Timeline
13 December 2021– the deadline of the 6-month grace period, after which 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;
13 December 2022 – deadline of the 18 months period for serialization reporting and onboarding onto Tatmeen
13 December 2022 – deadline for registration with a GS1 Global Location Number (GLN) of all sites that are licensed to dispense medicines in the UAE
Sources:
https://tatmeen.ae/pdfs/Technical%20Guide%20-%20MAH%20v1.0%20-%20English.pdf
https://tatmeen.ae/pdfs/MOHAP%20SERIALIZATION%20GUIDE%20V1.0%20EN%20FINAL1.pdf