Eng De Esp Ru Pt

Pharma (UAE)

13 June 2021 – Master Data – The requirement to submit the product information to the BrandSync Portal is part of the Medicines Barcoding and Serialization Guideline.

13 December 2021 – Serialization SSU – All Products must be labeled.

13 December 2022 – Aggregation & Reporting – Reporting: SN commissioning, aggregation, and shipping events to Tatmeen System. 

UAE Track & Trace regulations for pharmaceuticals

UAE Track & Trace regulations for pharmaceuticals
1

A pharmaceutical product that is distributed in UAE for human consumption is registered with the BrandSync portal. MAH which ships to UAE is registered and onboarded with Tatmeen Track & Trace Platform.

2

The product is serialized at the manufacturing location outside the UAE by applying a 2D DataMatrix on the saleable unit pack with information: GTIN, Unique random serial number, and Expiry Date. Each pack is further aggregated into cases and pallets which are uniquely identified with SSCC coding. MAH holder sends the EPICS Envelope which contains Commissioning, Aggregation, and Shipping events to Tatmeen Traceability Hub as soon as the shipping is performed.

3
The product may be shipped via 3PL or directly to Distributors/Wholesalers in UAE. MAH holder sends the EPICS Envelope which contains Commissioning, Aggregation, and Shipping events to Tatmeen Traceability Hub as soon as the shipping is performed. MAH must notify the distributor once the importation EPICS message is successfully sent to the Tatmeen solution.
4
The distributor receives the goods shipped from MAH or 3PL and sends the "Receiving" event to Tatmeen Traceability HUB after the goods are physically received at the location.
5
The distributor further ships the product to dispensers such as hospitals and sends a "Shipping" event to Tatmeen Traceability Hub at the time of shipping.
6
Despenser receives the goods shipped from the distributor and sends the "Receiving" event to Tatmeen Traceability Hub after the goods are physically received at the location.
7
Dispenser consumes the product by administering the medicine to patients and sends the "Dispensation" event to Tatmeen Traceability Hub.