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FMD 2019 – The clock is ticking in the phar­maceu­ti­cal in­dus­try: are you ready?

The fact is, serialization will soon be mandatory. Companies have just over half a year to implement the EU’s Falsified Medicines Directive and implement reliable serialization and labeling systems. In this interview, Philippe Dugougeat, Managing Director of BÖWE SYSTEC UK + Ireland, explains how you can easily meet this deadline and start implementation immediately.


Mr Dugougeat, the deadline for complying with the FMD is fast approaching. What exactly is FMD and why is it so important?

Philippe Dugougeat: According to estimates by the World Health Organization of the United Nations, one in ten drugs worldwide are counterfeit – in Europe it is one in a hundred. About one million people die every year as a result. Various international guidelines such as GAMP5, GMP and the Falsified Medicines Directive, FMD for short, are intended to put a stop to this. This EU directive will come into force on February 2, 2019 and makes reliable serialization and labeling systems mandatory for pharmaceutical manufacturers and logistics companies. The aim is to ensure the traceability of pharmaceutical products throughout the entire logistics chain as far as the end consumer by coding them with unique serial numbers.

Will this directive affect the whole pharmaceutical industry or are there exceptions?

Philippe Dugougeat: The EU directive will affect the entire pharmaceutical industry including pharmaceutical manufacturers, packaging manufacturers, secondary packers, pharmacies, wholesalers and other distributors. There are no exceptions, and nor should there be in the safety of medicines.

That sounds like a pretty big challenge for these companies. And there isn’t much time left until February 2, 2019...

Philippe Dugougeat: That's right. Companies have just over half a year to implement serialization. That's not much time to find their perfect solution. Ideally, this should adapt flexibly to existing company processes and also offer 100% security for revision-proof processing of serial numbers.

Companies that have not yet dealt with the implementation therefore need to hurry. How can BÖWE SYSTEC help?

Philippe Dugougeat: As a track & trace solutions specialist, we have developed a system solution especially for the pharmaceutical industry that meets all the requirements of GMP, GAMP5 and FMD. First of all, our German-made serialization module is particularly flexible and easy to implement due to its modular design. At the same time, it is the only system on the market to combine all the necessary functions in a single solution: automatic serialization and decommissioning, target-actual comparisons on delivery as well as checking the print quality or sampling using a hand-held scanner. In addition, the serialization module can reliably and safely process all common packaging sizes. This starts with the smallest folding boxes measuring 25 x 25 x 40 millimeters and extends to exceptionally large drug packaging with dimensions of up to 250 x 250 x 400 millimeters. This allows our system to handle a much wider bandwidth than other solutions on the market


And what about data processing?

Philippe Dugougeat: The most important thing is that no unique ID may be printed twice. Our serialization module ensures that no serial number can be assigned more than once worldwide and delivers absolutely error-free compliance with global pharmaceutical guidelines such as FMD or GMP and GAMP5 through immediate real-time data comparisons, even across locations. The position of each unit is known at all times thanks to seamless shipment tracking with the latest topCam reading and sensor technology. At the same time, the system’s security plays a major role in the downstream processing of drugs. Our software allows different access rights to be assigned based on different levels of authorization, and this delivers an additional level of security. And all this with highly intuitive software that can even network systems at international locations in step with corporate expansion.

So BÖWE SYSTEC is the right partner for companies that still need to implement serialization quickly?

Philippe Dugougeat: Absolutely. For many years, BÖWE SYSTEC has met the high quality and security requirements of banks, insurance companies and public authorities for sending personalized plastic cards and security-sensitive documents. We are now transferring this comprehensive track & trace know-how to the pharmaceutical industry and will support you in the fast and uncomplicated implementation of serialization in your company. Simply contact us and we will implement serialization in your company too – and do it by the deadline.


Alexandra Stölzle

Corporate Marketing
Phone +49 821 5702-305


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