Name: United Arab Emirates Pharmaceuticals
Brand: TraceLink

Products

Intelligent data management and reporting solutions to meet UAE traceability compliance requirements

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Product overview

Ensuring UAE regulatory compliance

TraceLink’s UAE Pharmaceuticals solution enables pharmaceutical manufacturers or MAHs who want to commercialize products within the UAE to comply with labeling requirements for serialization and reporting certain events to the UAE Ministry of Health and Prevention (MoHAP) through the Tatmeen reporting system.

With this product, you can access:

Core compliance solutions

Software validation

Staff training

Industry challenges

Understanding the need for new compliance solutions

Today’s marketing authorization holders and pharmaceutical manufacturers face immense challenges in managing regulatory compliance operations and navigating evolution in the industry. In the UAE, these challenges include:

Managing serial numbers for UAE products

To meet UAE compliance, companies must configure serial number templates to create serial numbers for the UAE market, store and maintain randomized serial number pools for each product, and allocate serial numbers to internal packaging lines and contract packaging partners.

Managing serial numbers for UAE products

Commissioning, aggregating, & tracking event triggers

Companies must have systems to receive commissioning and aggregation information from packaging lines and contract packagers, as well as configure and manage packaging hierarchies and aggregation relationships, and automate reporting based on event triggers where possible.

Commissioning, aggregating, & tracking event triggers

Remaining agile with changing reporting requirements

With recent changes to the Tatmeen central system, companies have had little time to plan, implement, and test new operations, including securely connecting and submitting compliance reports, while maintaining history and audit trails of compliance activities.

Remaining agile with changing reporting requirements

Product benefits

Partner with the industry leader in regulatory compliance

Since 2009, TraceLink has been the industry leader in delivering regulatory compliance and serialization solutions for the global pharmaceutical industry in more than 30 countries. With more than 280,000 trading partners on our digital supply network, TraceLink lets companies Integrate Once, Interoperate with Everyone™ for seamless data exchange and fast partner onboarding.

Product benefits

Monitor, scope, develop, and deliver

TraceLink has proven its ability to monitor, scope, develop and deliver compliance requirements in the most complex markets. More than 600 marketing authorization holders (MAHs) use TraceLink as their global serialization and compliance platform.

Product benefits

Mitigate functionality gaps

TraceLink’s compliance application is continuously updated as market requirements evolve to avoid any functionality gaps. Based on TraceLink’s experience developing compliance solutions across more than 35 countries in 9 diverse markets, TraceLink’s architecture is designed to support changing regulatory and business requirements while maintaining a validated system.

Product benefits

Comply with new & evolving regulations

TraceLink can help you comply with new and evolving regulations in the UAE—and around the world. Contact us to learn more about our solutions for the Eurasian Economic Union and other emerging markets.

Capabilities

TraceLink’s OPUS Compliance Platform

TraceLink's UAE Pharmaceuticals solution provides comprehensive master data, serialized product event, and compliance reporting capabilities for marketing authorization holders (MAH) to meet UAE regulations.