SERIALISATION AND TRACK&TRACE SOLUTIONS FOR EU PHARMA MARKETING AUTHORISATION HOLDERS

WHAT SETS OUR SERIALISATION SOFTWARE APART?

SEAMLESS INTERACTION WITH YOUR SUPPLY CHAIN PARTNERS

All organisations that manufacture, sell or dispense medicinal products in the European Union have until 9 February 2019 to comply with the EU’s Falsified Medicines Directive (EU FMD). The EU FMD not only ensures that medicinal products distributed in the EU are safe, but it will attempt to mitigate rising supply chain costs resulting from different national or regional traceability requirements and authentication mechanisms. The EU FMD requires that an end-to-end verification system be 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&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 centralised data management, you can meet EU FMD compliance and do so much more.

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Read our most frequently asked questions about the EU FMD.

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SEAMLESS INTERACTION WITH YOUR SUPPLY CHAIN PARTNERS

With the impending EU FMD deadline, time is of the essence. Our flexible, standards-based (e.g., 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 that 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 in terms of short- and long-term costs. Customers using OPTEL’s cloud-based serialisation 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.

ROI ON SERIALISATION INVESTMENT

We know your investment in a serialisation solution is enormous. So, when selecting your serialisation platform, focus on gaining insights—and not just connections—to leverage rich data to enable a more intelligent supply chain. Pharma organisations want relevant supply chain data right at their fingertips in an easy-to-use dashboard. From real-time production metrics and inventory insights to 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 serialise, verify and track individual products or groups of items at all levels so you can comply with the EU FMD. From materials and suppliers to manufacturing and distribution, our approach generates rich data insights to create Track&Trace data points, alerts and customisable reports for a more intelligent supply chain.

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

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