Press Release

Another EU country introduces IT Medication Authentication solution

• Arvato Systems implements IT solution for medication authentication in Spain
• Sistema Español de Verificación de Medicamentos (SEVEM) starts to carry out Falsified Medicines Directive requirements

(Arvato Systems) Gütersloh – Spain is the latest EU country to choose the Arvato Systems national verification system. With this contract signing, the country is reacting in a timely fashion to the 2011/62/EU EU directive against the falsification of medicines. Spain follows in the footsteps of other EU countries, including Finland, the Netherlands and Austria, who also rely on Arvato Systems as their implementation partner.

In line with EU Counterfeiting directive 2011/62, from February 9, 2019 prescription drugs may only be sold if they carry two specific security features: the unique identifier – a randomly generated serial number – which, combined with a product code, ensures that each package is unique, as well as a device to prevent tampering. The goal of the directive is to protect patients against fake medications within the legal supply chain.

End-to-end implementation of the system is currently in process on-site in Spain, with Arvato Systems responsible for project management and account management as well as post-implementation technical support. Spain is so far the only country to host the national verification system in their home country, Spain. This means that SEVEM is compliant with the requirements of the Spanish authorities.

In the future, before the product goes on sale, packaging information will be sent directly to the european hub and from there transmitted to the national repository. Each package will be scanned in the pharmacy before being handed to the customer. The data matrix code and individual serial number will confirm the validity of the product directly and with no wait-time. The pharmacy can only handover the package to the customer once the status has been recognized as valid. After the package has been passed to the customer, the status of the serial number immediately changes in the database: it is then recognized as used and cannot be issued again. Data protection for patients is achieved by separating manufacturer and pharmacy databases.

“With Spain as our customer, we are delighted to have gained another EU country, acting in good time and ready to rely on the services of our national verification system. February 9, 2019 is fast approaching, making it all the more important for countries to start setting up their national verification systems as soon as possible,” explains Peter Koop, Vice President Healthcare at Arvato Systems.

About Arvato Systems

Global IT specialist Arvato Systems supports major companies through digital transformation. More than 3,000 staff in over 25 locations epitomize in-depth technology expertise, industry knowledge and focus on customer requirements. Working as a team, we develop innovative IT solutions, transition our clients into the Cloud, integrate digital processes and take on IT systems operations and support.

In healthcare, Arvato Systems provides its own serialization solutions covering the entire end-to-end process chain. These solutions support both individual producers and national verification systems. Arvato Systems has been approved and certified as an official service provider by the European Medicines Verification Organization (EMVO). We rely on a dedicated team of serialization experts who have already carried out numerous international projects.

As a part of the Bertelsmann-owned Arvato network, we have the unique capability to work across the entire value chain. Our business relationships are personal; we work with our clients as partners, so that together we can achieve long-term success. arvato-systems.com