Serialization for Small Pharma: TraceLink targets low volumes and simple supply chains
The EU FMD Express is designed to help smaller firms meet the impending 2011 Falsified Medicine Directive (FMD), which comes into effect on February 9, 2019.
The FMD is designed to prevent entry of falsified medicines into the pharmaceutical supply chain.
According to the firm, smaller companies can struggle with master data management and data exchange with their contract manufacturing organisations (CMOs).
This service is customised for those companies with lower product volumes and limited target markets, that do not have the resources to focus on FMD compliance, vice president of global pre-sales Dan Walles told us.
“EU FMD Express addresses this by TraceLink taking more ownership of the configuration and deployment, so that the customer does not have to,” he said.
The offering – which uses purpose-built templates and compliance modules for faster implementation and predictable costs – enables access to TraceLink’s serial number and event repository, and allows integration with Europe’s central data router, the EU Hub.
Walles told us although the service was recently introduced, market response has been favourable: “The interest across the entire region has exceeded our expectations, and in just the extremely short timeframe that EU FMD Express has been available, we have secured a handful of customers.”
In February, industry raised concerns about the ‘readiness’ of pharmaceutical firms 12 months out from the FMD deadline.
If manufacturers “are yet to begin their serialisation programmes, then they may find themselves facing an uphill battle to meet the deadline,” said serialisation provider SEA Vision’s Marco Baietti at the time.