[Blog] Tatmeen – the UAE’s first Track &Trace solution for the Pharma industry is going into force
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Tatmeen, UAE`s Traceability system, is in the final stretch of officially going into force
From 13th December 2022, all participants involved in manufacturing, distributing and dispensing pharmaceutical products must be ready with the Serialization and Track and Trace (T&T) requirements. The legislation was published by UAE`s Governmental Department for Healthcare and Prevention (MoHAP), applying to the entirety of the UAE territory as becoming effective:
- Immediately before foreign product importation into the UAE
- Immediately before domestic manufacture release into the UAE
The document clarifies the specific categories of products relevant to the legislation, marking off the exceptions such as product recalls.
Products that require serialization include all conventional medicines sold, distributed, or stored in the UAE.
Products that are exempt from serialization include:
- Free samples of pharmaceutical products
- Pharmaceutical products imported for personal use only
- Medical Devices and Supplies
- GSL Products
The process
Serialization
All products on the UAE market must display a serialized unique identifier on the product’s secondary packaging.
All secondary packaging sold, imported, produced and supplied to the UAE must be serialized. Secondary packaging must have the following data elements on it and encoded in a GS1 DataMatrix:
- Global Trade Item Number (GTIN)
- Randomized Serial Number (1/10,000 randomization)
- Expiry Date
- Batch or Lot Number
Aggregation
Also, aggregated packaging (aggregated homogenous products or logistics units) must display a serialized unique identifier. Logistic Units must be aggregated and identified with an SSCC (Serial Shipping Container Code). All Logistic Units must be aggregated and barcoded using a GS1-128 barcode. The SSCC should be encoded in a GS1-128 using AI (00).
The manufacturer does aggregation on all applicable packaging levels to ensure ease of downstream reporting. Distributors, wholesalers and health facilities that unpack and re-pack products to deliver to dispensing points are required to aggregate the Logistic Units using their SSCC codes. If, in addition to being a Logistic Unit, the item is regarded as a Trade Item by the brand owner, it may be identified with a GTIN.
To ensure that no additional risk or inefficiencies are created by having both a linear and a GS1 DataMatrix barcode, MoHAP recommends that all secondary packaging should only have a GS1 DataMatrix barcode. If a linear barcode and a GS1 DataMatrix are present on the secondary packaging, both barcodes need to be encoded with the same GTIN.
The information recorded by the participants must be transmitted to the Tatmeen traceability system, where it is stored. The stored data is made available for regulatory purposes to the authorities of the UAE MoHAP departments.
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