SERIALISATION FOR EU PHARMA MARKETING AUTHORIZATION HOLDERS

SEAMLESS INTERACTION WITH YOUR SUPPLY CHAIN PARTNERS

All organizations that manufacture, sell or dispense medicinal products in EU Member States have until February 9, 2019 to comply with the Falsified Medicines Directive (FMD). The FMD not only ensures that medicinal products distributed in the EU are safe, it will attempt to mitigate rising costs for supply chain organizations that are a result of different national or regional traceability requirements and authentication mechanisms. FMD requires that an end-to-end verification system is in place for an individual pack of a medicinal product for the entire time it’s in the market, as well as any time necessary for returning and disposing of the pack after it has expired. The legislation applies only to prescription medicines unless the product is considered at risk of counterfeiting.

YOUR CHALLENGES AND OUR SOLUTIONS




COMPLIANCE WITH GOVERNMENT REGULATIONS

We know that achieving compliance is your top goal. Our proven track and trace software, automated implementation tools, and time-tested project management framework rapidly and efficiently ensure that you check the compliance box, and get the data and insights that drive your business forward. With item-level traceability, product packaging and shipping hierarchies, real-time updates and centralized data management you can meet EU FMD compliance, and do so much more.

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Read our most frequently asked questions about FMD.

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SEAMLESS CONNECTION TO TRADING PARTNERS

With the EU FMD deadline only months away, time is of the essence. Our flexible, standards-based (i.e., EPCIS) enterprise platform can facilitate rapid, seamless interaction with your supply chain partners early and often in the planning process.

OPTEL’s Verify Brand® Software can store and pass along all the data national regulations require, including any additional data that must be printed on the cartons. We give you flexible integration and configuration options for a swift, frictionless implementation to connect and communicate with other systems to receive the business insights you need.

COST OF OWNERSHIP AND HIDDEN FEES

Our mature, stable platform, proven across industries and time, provides complete transparency to short and long-term costs. Customers using OPTEL’s cloud-based serialization and traceability software incur no hardware/infrastructure, IT personnel, maintenance, or storage costs whatsoever. In addition, we’re not playing catch-up with our technology; it’s been refined for more than a decade, and you benefit from our expertise and efficiencies.

ROI ON SERIALIZATION INVESTMENT

We know your investment in a serialization solution is huge. So when selecting your serialization platform, focus on gaining insights – and not just connections – to leverage rich data and insights to enable a more intelligent supply chain. Pharma organizations want relevant supply chain data right at their fingertips in an easy-to-use dashboard. From real-time production metrics, inventory insights, supply chain anomalies and more, OPTEL gives you built-in reports and analytics so you don’t have to spend hours manually compiling and interpreting data.

OPTEL’s L4-L5 software is designed to quickly and efficiently serialize, verify and track individual products or groups of items at all levels so you can comply with EU FMD. From materials and suppliers to manufacturing and distribution, our approach generates rich data insights to create track and trace data points, alerts and customizable reports for a more intelligent supply chain.

Learn why OPTEL's compliance solution is the gold standard of Track&Trace solutions.

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