UAE Tatmeen Archives - rfxcel.com
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UAE Tatmeen Track and Trace System: Just the Facts

There’s a deadline coming up for the UAE Tatmeen track and trace system, so we figured it was a good time to take another look at the platform that will, as the government says, “safeguard the entire supply chain.” We’re going to focus on just the facts today. For a more comprehensive look, check out the article we wrote earlier this year.

What is the UAE Tatmeen track and trace system?

“Tatmeen” means “assurance” in Arabic. The Ministry of Health and Prevention (MOHAP) introduced the system in June 2021 “to ensure protection of public health and improve the security of healthcare at all stages.” It will do this by tracking and tracing all pharmaceutical products and medical devices that enter the country.

In addition to MOHAP, three UAE-based organizations are involved in the Tatmeen system:

      • The Dubai Health Authority (DHA) oversees the “complete health sector” in Dubai and promotes engagement with the private sector. Tatmeen will integrate with the DHA’s electronic medical record system and utilize its paperless drug and medical supplies management system.
      • The Department of Health—Abu Dhabi is the regulative body of the healthcare sector in the Emirate of Abu Dhabi. It “shapes the regulatory framework for the health system, inspects against regulations, [and] enforce[s] standards.”
      • EVOTEQ is a “digital transformation catalyst” that promotes innovation, including digitalization, particularly in public-private partnerships.

GS1 UAE is also involved, as the UAE Tatmeen track and trace system is based on GS1 standards. This includes using GS1’s BrandSync platform as a central reporting repository.

How does the UAE Tatmeen track and trace system work?

Tatmeen is structured around GS1 barcodes and scanning products as they enter the country and move through the supply chain. Explained simply, the process looks like this:

      1. Manufacturers put a GS1 barcode on every product. Manufacturers are responsible for aggregation. They must obtain a license from MOHAP to import “conventional, biological or other human pharmaceutical products.” As in other countries, this is a multi-step process. See the MOHAP website for more information.
      2. Customs officials scan products to get detailed information and verify they are legitimate before allowing them into the country.
      3. Distributors and logistics providers scan to keep track of inventory, provide another layer of protection, and help ensure products are delivered to the right place in a timely manner.
      4. Healthcare providers at hospitals, clinics, and other facilities scan to verify a product’s legitimacy and expiration date prior to dispensation.
      5. Patients and consumers can also scan to check the safety and authenticity of products.

Tatmeen timeline, next deadline, and news

As we noted above, MOHAP introduced the UAE Tatmeen track and trace system last June. The first deadline was Dec. 13, 2021, when manufacturers and marketing authorization holders had to be registered with the BrandSync platform and begin using 2D DataMatrix codes.

Truth be told, it’s been pretty quiet since then, with industry getting ready for the next deadline — Dec. 13, 2022 — which concerns serial number reporting, aggregation, and Global Location Numbers (GLNs). See our previous article for those details.

Several updated technical documents have been posted on the Tatmeen website this year:

      • Technical Guide for Dispensers (v2.0, March 21, 2022)
      • Technical Guide for Logistics (v3.0, May 30, 2022)
      • Technical Guide for Manufacturers (v4.0, July 6, 2022)

The Tatmeen Serialization Implementation User Guide, “GS1 Barcoding of Conventional Medicines: An Introduction and Reference Guide,” is still in v1.0, dated Aug. 10, 2021.

One notable event was a 4-day Tatmeen workshop held this past June. Co-hosted by MOHAP and EVOTEQ, it gathered representatives from the DHA, the Department of Health–Abu Dhabi, the Emirates Health Services (EHS), and Federal Authority for Identity, Citizenship, Customs and Ports Security to discuss progress made, attracting manufacturers, and connecting stakeholders in the platform.

Speaking at the workshop, Ahmad Ali Al Dashti, assistant undersecretary for the support services sector at MOHAP, and Ali Al Ajmi, director of MOHAP’s Digital Health Department, said the UAE Tatmeen track and trace system is leveraging technology to transform the health sector and continue the country’s position as a role model for assuring the safety of pharma products, including by fighting counterfeits.

Final thoughts

The UAE Tatmeen track and trace system is the perfect example of how the global push for pharmaceutical traceability and serialization is not slowing down. Quite the opposite, in fact.

Sure, some regulations and big deadlines get more attention than others — the U.S. Drug Supply Chain Security Act leaps to mind — but rest assured other countries are hard at work to modernize and digitalize their supply chains. A few examples that we’ve covered recently include Kazakhstan, Uzbekistan, Egypt, and The African Medicines Agency.

We’re here to help you understand the global regulatory landscape, answer your questions, and help ensure you’re able to do business everywhere you supply chain goes. In terms of the Middle East specifically, we have people on the ground implementing traceability hubs in Lebanon and the Kingdom of Bahrain; we have the know-how to make your supply chain safe, secure, and compliant while optimizing your operations and growing your business.

Contact us today to learn more. In about 15 minutes, we can show you how our automated, intuitive technologies actually make it easy to meet regulations and improve your supply chain.

UAE Pharmaceutical Products Traceability Requirements for 2022: “Tatmeen” Platform

The global push for pharmaceutical traceability and serialization continues at a furious pace. Today, we’re looking at the United Arab Emirates (UAE), whose Ministry of Health and Prevention (MOHAP) in June 2021 announced the “Tatmeen” platform for UAE pharmaceutical products traceability. There are key deadlines this year, so let’s take a look.

UAE Pharmaceutical Products Traceability and the Tatmeen System

MOHAP established Tatmeen, which means “assurance” in Arabic, in Ministerial Decree No. 73 on June 14, 2021. Described as a “central command center,” it’s a GS1-based platform for UAE pharmaceutical products traceability. MOHAP’s partners include the Dubai Health Authority (DHA), Department of Health (Abu Dhabi), and EVOTEQ, a “digital transformation catalyst” based in the UAE, and GS1 UAE.

Tatmeen’s goals should sound familiar:

    • Fight counterfeits and illegal and substandard medications
    • Eliminate unauthorized imports
    • Improve recall management
    • Ensure expired and about-to-expire drugs don’t reach consumers
    • Forecast demand and avoid shortages
    • Move drugs where they’re needed quickly and safely
    • Protect pharma companies, including their intellectual property rights

These other aspects should also sound familiar:

    • Products are scanned at every node of the supply chain
    • Product information is reported into to a central repository (in this case GS1’s BrandSync platform)
    • Scanning captures and verifies data in real time and reports information into a central database
    • Hospitals and pharmacies scan when drugs arrive at their facility and when they’re dispensed
    • Patients and consumers can scan with mobile devices to validate products, report expired products, fakes, and suspected gray market activity

Tatmeen will integrate with the DHA’s electronic medical record system, Salama (incorrectly identified as “Salam” in some industry sources). It will also utilize DHA’s Tarmeez, a paperless drug and medical supplies management system that gives authorized users access to a centralized electronic catalog of all available inventory.

Tatmeen labeling and reporting requirements

All conventional medicines sold, distributed, or stored in the UAE are regulated and must be serialized. These products are exempt:

    • Free samples
    • Products imported for personal use only
    • Medical devices and supplies
    • General sales list (GSL) products

And —surprise, surprise — UAE pharmaceutical products traceability requirements should sound familiar. Secondary packaging must contain four data points in a GS1 DataMatrix code and in human-readable form:

    1. Global Trade Item Number (GTIN)
    2. Randomized serial number (up to 20 characters)
    3. Expiry date (in YYMMDD format)
    4. Batch or lot number

This example is adapted from the MOHAP’s serialization guide:

UAE DataMatrix Code

Aggregation requirements should also ring a bell: All logistic units must be aggregated and labeled with a GS1-128 barcode encoded with a serial shipping container code (SSCC). Manufacturers are responsible for aggregation.

If a brand owner regards an item as a trade item, “it may additionally be identified with a GTIN.” Distributors, wholesalers, and health facilities that unpack and re-pack products to deliver to points of dispensing are required to aggregate the logistic units using their own SSCC codes.

Marketing authorization holders (MAHs), brand owners, manufacturers, or their subsidiaries must register and upload the mandated product master data into the BrandSync platform.

Domestic and foreign manufacturers, third-party logistics providers, batch releasers, contract manufacturing organizations, distributors, licensing agents, and MAHs are responsible for collecting serialized product item traceability records and reporting them to Tatmeen.

UAE pharmaceutical products traceability rollout and 2022 deadline

There was a 6-month “status adjustment” period after Tatmeen was announced for manufacturers and marketing authorization holders to register with the BrandSync platform and begin using 2D DataMatrix codes. This deadline passed on December 13, 2021.

The next major deadline is December 13, 2022. By that date, all supply chain actors in the UAE must obtain a Global Location Number (GLN) from GS1 UAE to identify their organization, where it’s located, and other required information. Relevant stakeholders must also begin reporting serial numbers to Tatmeen and begin aggregation with GS1-128 barcodes and SSCCs.

Final thoughts

We noted a few times that parts of the Tatmeen regulations should sound familiar. If you follow our blog and read our articles about pharmaceutical regulations in other countries — DSCSA in the United States, Chestny ZNAK in Russia, ANVISA in Brazil, ASL BELGISI in Uzbekistan, and so on — everything about UAE pharmaceutical products traceability should ring a bell.

As we said right at the start today, the global push for pharmaceutical traceability and serialization continues at a furious pace. Requirements may vary from country to country, but their essence is the same (e.g., protecting consumers, serialization, traceability, electronic reporting, central repositories, GS1 standards). Tatmeen is just one more example in a very large regulatory ocean.

It’s easy to feel swept up in this current. And, truth be told, if you’re not complying now or preparing to comply by published deadlines, you’re putting your business in jeopardy. If you have questions about Tatmeen or complying with pharmaceutical serialization and traceability regulations in any country, contact us today. In just a few minutes, our supply chain specialists can demonstrate how our award-winning Traceability System ensures you’re compliant in any country, today, tomorrow — always.

For even more information, check out our Global Compliance Page, download our Worldwide Pharmaceutical Compliance Requirements white paper, and catch up on other pharma news in our blog: