With just two years to go before the EU's patient safety rules for medicines become binding, Germany's traceability platform has passed some important milestones.
Under the Falsified Medicines Directive (FMD) delegated act on safety features, prescription medicines will have to carry a unique identifier (a randomised serial number) encoded in a 2D barcode and a visible anti-tampering device by February 9, 2019.
More than 100 pharma companies have now linked in to the national securPharm database, to which pharma manufacturers will upload unique identifiers and product master data, and in turn will link through to a central EU hub and allow verification of packs at various points in the supply chain and final decommissioning when medicine packs are dispensed to a patient.
securPharm says its database is now ready for all-comers and it predicts another 100 companies will be hooked up to the system before the end of the year. Meanwhile, with test packages of transaction data already starting to be uploaded to the European hub, the system is firmly on track to meet the 2019 deadline, according to chief executive Dr Reinhard Hoferichter.
Hoferichter recommends that drugmakers use the interim period to make sure staff are trained and that their systems can handle the new processes. "In view of the complex requirements, the remaining two years are a short time for implementation," he said.
Experience to date has shown that it takes more time and effort than originally expected to come into compliance, since "almost all processes of drug production have to be tackled."
2017 will also see the completion of a new version of the software used by pharmacies and wholesalers that will be able to handle the high volume of users that will have to link in when the national system goes live. Next year, the volume of transactional data going through the system will be ramped up so that all 20,000 pharmacies and wholesalers in Germany will be ready for the deadline.
"With this roadmap, we are confident that we will be able to build up a functioning technical system available to users by February 9, 2019," said Hoferichter.