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Date: 17-01-2019

Basic Pharma meets EU serialisation requirements

Early start enables Basic Pharma to be compliant in time with the EU Falsified Medicines Directive

Basic Pharma have chosen Arvato’s CSDB software to exchange serial numbers with their customers and to control their packaging lines. With the start of serialised operations, a simple flag “with Serialisation” is now set, which changes the packaging of prescription drugs from the traditional Lot/Exp to full FMD compliance. This is already in place for a number of customers and will soon apply to all. It is as simple as that….

However, it has taken a lot of effort from Basic Pharma, their customers and their implementation partners Vioprint and Arvato, but we managed in time. From now on all our manufactured prescription drugs are compliant with the EU Falsified Medicines Directive and the Delegated Act. We have been working on this project since the beginning of 2017, allowing us to gain sufficient knowledge and expertise, make the right decisions and investments and be well prepared to support our customers. Since March 2018, the serialisation project became visible to the organisation with the installation and validation of the reliable Wipotec-OCS packaging lines.

Piet Meindertsma, Project Manager at Basic Pharma for this project commented: “The result of the project is clearly visible for anyone familiar with the packaging operations as the set-up of the packaging department was changed to accommodate the new serialisation equipment. Less visible, but challenging as well was the imprint of the 2D barcode with the required human readable information: a large number of our folding boxes are too small to print all information on one flap. We developed a solution, which our customers accepted and meets the requirements laid down in the Delegated Act. One of the last challenges in the project was the search for a tamper evidence provision. Testing on a small scale turned out to be very different from trying to produce a batch with 48.000 folding boxes. Together with Vioprint, we introduced a new label type, which meets both the FMD regulation and Basic Pharma’s requirements for a smooth and reliable production process. We use these labels now in large volumes; the packaging operations are back to ‘business as usual’. We already started to ship FMD-compliant (“serialised”) batches to our customers since the end of 2018.”

Looking back it is safe to say that it was a lot of hard work with pitfalls, challenges and successes. The project was challenging at times, because it requires dedication and vigor from all parties involved: customers, implementation partners and ourselves. Although not everyone was at the same speed all the time, we thank our customers, as they play a very important role to make serialisation a success and avoid medicines shortages in the market.

Serialisation and the Delegated Act: we are ready for it!

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