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01 October 2020
Responding to the biggest ever change in the pharmaceutical industry
The Falsified Medicines Directive aims to prevent the distribution of counterfeit medicines in the EU. We successfully adapted our processes in line with this directive last year – and we are now implementing further measures in non-EU countries.
“We’ve embraced changes in our industry to strengthen our processes and ultimately patient safety.”
The Falsified Medicines Directive (FMD) is a new piece of legislation that aims to stop counterfeit medicines from being dispensed by pharmacies within the European Union (EU). It came into force in February 2019, and people across Grünenthal worked tirelessly to adapt our processes to meet these new requirements in time. Their tasks included installing new printers and cameras on our packaging lines, gaining official approval for our packaging artwork, adapting our master data approach, signing contracts with national regulatory authorities, and setting up interfaces with the new system to report and confirm the authenticity of our products. As a result of this hard work, Grünenthal became one of the first 20 companies to fulfil the requirements for connecting to the European system for FMD. This achievement shows the strength of our dedication to ensuring patients’ safety – and we are now taking further steps to meet changing requirements in countries outside of the EU.
Grünenthal’s efforts to adapt to the FMD involved some impressive milestones. We processed more than 63 million serial numbers in 2019, while connecting 31 European countries via the EU HUB platform, as well as 14 suppliers and 11 customers for our Contract Manufacturing Business. On top of this, we have reduced technical and process-based errors by 90 percent from February 2019 until today.
Moving forward, we are going to keep working closely with authorities and system vendors to further improve serialisation and comply with changing requirements worldwide. Most countries outside of the EU are aiming to follow standard Serialisation, Track & Trace (STT) approaches that are, in principle, based on the FMD. However, some countries have evolved a different setup that requires product tracing along the entire supply chain – with every movement reported on the system, from the manufacturer through to the pharmacy. Our business in the US already operates in line with FDA regulatory requirements for Serialisation, Track & Trace, and we serialise for China, Saudi Arabia, South Korea, and countries in the Middle East and North Africa. In August, we began shipping batches of products in line with new requirements for serialisation and aggregation in Russia. And we are currently adapting processes across our global network of sites to meet changing requirements in Brazil. Through strong collaboration, our teams worldwide are making an important contribution to protecting our company’s market access – and making sure patients around the globe have access to safe medicines.