Many countries created legislation mandating safety regulations for life sciences and pharmaceutical companies to keep patients safe. Manufacturers began to adopt solutions to meet these requirements and stay in compliance as the rules are updated over time. Each country has similar components to their regulations, yet there are also unique characteristics.
In the United Arab Emirates (UAE), the Ministry of Health and Prevention (MoHAP) is implementing a track and trace system to secure products and protect consumer safety. The system, Tatmeen, is a fully automated, paperless drug and medical supplies management system for the UAE Healthcare sector. In January 2023, the regulation is due to come into effect for pharmaceutical companies with business in the UAE market.
MoHAP Regulations and Requirements
MoHAP’s initial goals with the new regulations in the UAE are to automate processes, utilize GS1 compliant serialization while improving visibility, safety and reliability of pharmaceutical supply chain. All products imported or domestically manufactured are required to have a 2D Matrix Barcode for tracking, and companies must be registered with a Global Location Number (GLN). These mandatory regulations ensure Tatmeen has the information it needs to monitor production and increase visibility and safety within the UAE healthcare sector. Companies should begin evaluating the steps they should take to become compliant with the MoHAP requirements.
Preparing For UAE Compliance
A combined track and trace solution from Movilitas and SAP enable life science companies to:
- integrate and share their data so that it complies with Tatmeen
- provide a serialization repository and management
- facilitate the exchange of serialization data with the extended supply chain network
Being integrated with the backend and packaging lines, SAP Advanced Track and Trace for Pharmaceuticals (SAP ATTP) facilitates company-wide serialization with readily available country-specific regulatory reporting packages.
We know that becoming compliant with new regulations can often be a challenge. As the partner of choice, together with EVOTEQ we have brought Tatmeen, the national serialization system, to the UAE. With the knowledge of track and trace and pharma compliance we advise clients to better understand each country’s requirements and select the best solution for implementation. However, these projects do require a certain amount of effort at the beginning. The benefit is not only a fully traceable system, but also improved reliability and safety that protects your reputation and can improve profitability from new efficiencies.
For more information, download our comprehensive guide A Practical Approach to Pharma Serialization in the United Arab Emirates.