Over the past few years, the Middle East has taken significant strides in implementing traceability regulations, particularly in countries like the UAE, Bahrain, and Saudi Arabia. With governments prioritizing patient safety and counterfeit prevention, serialization and traceability requirements have become mandatory in the pharmaceutical and healthcare supply chain.
However, compliance has not been a straightforward journey. While traceability initiatives brought much-needed transparency, serialization operations introduced a new layer of operational and technical complexity that organizations are still grappling with.
The Reality of Serialization on the Ground
Implementing serialization is not just about printing barcodes or generating unique identifiers. It’s about embedding a robust, tamper-proof digital trail into an already diverse and fragmented supply chain. For many companies operating across the Middle East, the real challenge has been adapting serialization and aggregation into their daily workflows without disrupting operations or eroding profit margins.
Here are a few key scenarios and pain points that have emerged:
- Non-registered products often lack serialization and aggregation entirely.
- Registered products may be serialized but frequently miss the required aggregation.
- Marketing Authorization Holders (MAHs) are not always ready or capable of reporting serialized events to federal systems.
- Downstream partners such as distributors and retailers often lack the infrastructure or readiness to handle serialized data.
This mix of preparedness across the ecosystem has created inconsistencies, making it difficult to maintain end-to-end visibility.
Key Operational Challenges
Serialization and aggregation introduced an entirely new set of operational hurdles:
- Cost-Efficient Serialization: Implementing serialization and aggregation infrastructure without significantly impacting gross margins remains a top concern.
- Discrepancies During Aggregation: Manual errors during item aggregation can cause miscounts, leading to mismatches between physical and digital inventories.
- Global Location Numbers (GLNs): Acquiring accurate GLNs from downstream partners is often a slow and incomplete process.
- Code Generation & Management: Generating GS1-compliant codes like SGTIN and SSCC is technically demanding.
- EPC Management: Encoding and decoding Electronic Product Codes (EPCs) requires precision and standardized handling.
- File Translation & Data Exchange: Translating serialized data into the format required by federal traceability systems adds another layer of complexity.
These challenges make it clear that serialization is not a plug-and-play solution, it’s a dynamic operational model that requires alignment across the supply chain.
The Paradox of Software
Ironically, companies that invested in serialization software often faced additional hurdles. Many legacy systems, built with the intention of simplifying workflows and increasing accuracy, ended up doing the opposite. Misconfigurations, lack of interoperability, and poor user interfaces made day-to-day operations more complex instead of more efficient.
A serialization system, to be effective, must be:
- Focused on the right workflows,
- Efficient in handling large volumes of serialized data,
- Error-Free with robust checks and balances.
Any deviation—however small—can result in cascading issues downstream, affecting shipments, product availability, and compliance reporting.
Where Do We Go From Here?
While the region has made commendable progress, the journey is far from over. To move forward, stakeholders must focus on:
- Training and Change Management: Ensuring that teams understand the importance of serialization and are equipped to handle it.
- Collaborative Ecosystems: Engaging downstream partners early and ensuring data standardization and connectivity.
- Future-Ready Software Platforms: Investing in flexible, modular serialization solutions that can evolve with regulatory changes.
Final Thoughts
Serialization and traceability are not just regulatory checkboxes - they are the foundation for a safer, more transparent healthcare supply chain. The Middle East is well on its way, but continued collaboration, innovation, and adaptability will be essential in making these systems truly seamless.
The cost of oversight in serialization is high. But with the right focus and systems in place, the benefits in terms of compliance, safety, and trust far outweigh the challenges.
How can CosmoTrace help?
We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing them for the existing and upcoming regulations across the globe.
We are well versed with the compliance regulations for various markets and can help you with implementing the Middle East pharmaceutical serialization requirements.
Our team of experts strategize and plan end-to-end solutions using a combination of years of knowledge in product serialization, pharmaceutical supply chains, life sciences and brand integrity.
Disclaimer
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