Deadline to meet EU legislation on serialisation is fast approaching


DSM Sinochem Pharmaceuticals (DSP) is ready for full support of customers and partners, having implemented serialisation, a tracking and tracing system to reduce prescription drug counterfeiting

Deadline to meet EU legislation on serialisation is fast approaching

Global legislation on serialisation, aiming to reduce counterfeiting of prescription drugs by tracking and tracing the passage of prescription drugs through the entire supply chain, will be effective in Europe from February 2019.

With this status, DSP is one of the frontrunners in serialisation in the European generics pharmaceutical industry and aims to have its full supply chain onboarded and ready before year’s end 2018.

Solution for counterfeit drugs

Fuelled by online sales, unsecured physical and cyber global supply chains and minimal punishments, counterfeit prescription drugs have become an exploding industry. According to the WHO up to 15% of all medicines circulating in the developed countries and 30–40% in developing countries, are falsified.

The effects of these counterfeit drugs cause major threats to both human health as well as the reputation of pharmaceutical brands.

Product serialisation is the global answer against counterfeit drugs and drug adulteration, and should significantly reduce the production and distribution of falsified drugs.

The tracking and tracing system of serialisation can identify drug products by a unique serial number next to their origin, shelf life and batch number, and allows tracing of the product lifecycle from production, distribution to the end-user.

Comprehensive system

Serialisation requires all partners in the supply chain to implement a multitude of comprehensive systems and processes.

Next to the use of the unique serial number and tamper-evident per packaging, collaborative action from partners throughout the supply chain is needed for accurate recording, tracking and managing of data as the product moves from manufacturer, to the marketing authorisation holder, to pharmacists and other dispensing points.

Flexible solution

DSP is one of the first generics companies to be fully prepared to help customers and partners to onboard on serialisation, having implemented and thoroughly tested its flexible SAP-ATTP 2.0 solution in conjunction with Pharma Network.

Frans Oostland, Project Manager Serialization for Drug Products at DSP, said: “We have chosen our system for its unique capabilities and flexibility to communicate with every other system available on the market. The potential of our solution was recognised with a runner-up award during the recent Pharma TRACKTS! Conference on serialisation in Berlin.”

Full service to customers and supply chain partners

Implementing serialisation proves to be a challenge to many. It is currently estimated that 40% of companies in the pharma supply chain will not be ready in time. Being a frontrunner in Europe, DSP offers an onboarding plan for its customers and supply chain partners as a service and business advantage.

Michael Hartmann, Business Unit Director for Drug Products at DSP, said: “We are now ready to help our customers and supply chain partners to implement serialisation, and connect their systems to ours for optimal communication and seamless collaboration.”

“In addition, we offer extra services in the serialisation process, such as generating serial numbers on behalf of our marketing authorisation holders. Our main goal with this is to fully unburden our clients in both preparation and the actual execution.”

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