“With our measures we provide safe medication for patients and build a robust, data-driven supply chain.”
The European Medicines Verification System (EMVS) is a new platform developed in response to EU legislation called the Falsified Medicines Directive (FMD). Introduced in 2011, the FMD requires packaging for all prescription medicines to include a tamper-proof seal, a unique serial number and a 2D data matrix code containing detailed information about the product. When a pharmacist scans the packaging, the serial number and the data in the matrix code are compared to the information uploaded to the EMVS – and if they don’t match, the pharmacist receives an alert. This aims to stop counterfeit medicines from entering the legal supply chain and to protect patients against falsified pharmaceutical products that may contain abnormal doses of active ingredients or harmful substances. Interpol, Europol and national medicines agencies seize many falsified medicines and close hundreds of illegal websites every year. In 2017, counterfeit medicines of a value of nearly €7 million were seized at the EU borders.
At Grünenthal, we are 100 percent committed to supporting the FMD and its aim of increasing safety for patients – and we now have everything in place to bring this legislation to life. We joined forces with partners from across industries through our participation in a working group within the European Federation of Pharmaceutical Industries & Associations (EFPIA), as well as through involvement in the European Medicines Verification Organisation (EMVO) User Group. In fact, Grünenthal’s CEO, Gabriel Baertschi, is a member of the executive working group within EFPIA that is directly focused on this topic. Together, we’ve managed to get the new verification system ready to operate in time for the ambitious deadline of February 2019.
Implementing the requirements of this legislation was one of the largest infrastructure projects the pharmaceutical industry has ever faced. It affects everything from machinery and packaging production lines through to IT infrastructure and much more. At Grünenthal, we launched an implementation program bringing together colleagues from our Regulatory, Legal, Supply Chain, Production and Marketing teams to work with national associations, the EU and other organisations. By means of outstanding collaboration, our teams turned this challenge into a unique opportunity to make our supply chain even more robust and make sure patients can trust our products. Grünenthal was one of the first 20 companies to have received certification in line with this new legislation. This demonstrates our dedication to ensuring patients’ safety – and providing innovative pain medicines that improve patients’ quality of life.
The Grünenthal Serialization, Track & Trace Core Team (from left): Guido Holzem, Global GxP Intelligence Manager, Harald Lange, Project & Application Manager Serialization, Track & Trace, Jud Fidalgo, Project & Application Manager Serialization, Track & Trace, Bettina Friedrich, Project Manager Partner Onboarding Serialization, Track & Trace and Michael Völlinger, Program Manager Serialization, Track & Trace.