Pharma Serialization Regulations of the UAE: Abu Dhabi

Abu Dhabi track and trace pharma

In Abu Dhabi, medicines must be serialized since the beginning of 2022. The Arab Emirates (UAE) are gradually implementing pharma serialization regulations.

Competent authority: Ministry of Health and Prevention (MoHaP), UAE

Products: all pharmaceutical products listed with the Department for Health as approved drugs

Code type: GS1 Data Matrix

Aggregation: Required starting January 2023Despite cooperation on this point, pharma serialization has not been implemented across the board in the UAE; each emirate has its timeline. In Dubai, for example, serialization has been required since mid-2020. More than one and a half year later, in January 2022, the deadline for pharma serialization in Abu Dhabi was in effect. From that point on, all pharmaceutical products registered with the Ministry for Health and Prevention and approved by the Department for Health must be equipped with the GS1 barcode system.

The serialization code in Abu Dhabi contains the following information:

  • GTIN (Global Trade Item Number of the product)
  • Expiration date
  • Lot/Batch number
  • Serial number of the respective packaging

Abu Dhabi follows a four-step process. Since January 1, 2022, pharmaceutical companies must register with the GS1 UAE Portal and upload all the above product data. Since the same day, pharmaceutical products without a corresponding QR code are no longer allowed to be sold in Abu Dhabi. The Dubai Health Authority (DHA) may decide to extend the deadlines for certain products in individual cases to ensure the continued availability of medicines in Abu Dhabi. Also, from January 1, 2023, onward, aggregation will be mandatory, as well as serial number reporting in Tatmeen. Furthermore, every actor within the supply chain must acquire a Global Location Number (GLN). This leads companies to register with GS1 UAE and their most important information is stored.

Overview:

  • Pharmaceutical registration: January 1, 2022
  • Introduction QR code: January 1, 2022
  • Aggregation: January 1, 2023
  • Serial number reporting in Tatmeen: January 1, 2023

Track & Trace Platform Tatmeen

To develop a centralized platform, the UAE Ministry of Health has partnered with a serialization provider, EVOTEQ, based in the United Arab Emirates. Together they are developing the track-and-trace platform “Tatmeen“. It will not only be used to track the individual events in the drug supply chain but will also enable consumers themselves to check their medicines for authenticity and safety.

In the future, there are also plans to expand the system to include veterinary products.

More information about Global Compliance

[Disclaimer.]

This information is only one possible interpretation of the regulations. They are also constantly changing, so the information in this article may be incomplete or out of date. The above article is expressly not legal advice. Please consult the official documents for more information before making any business decisions. (Status of information: August 2022)

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