The EU Falsified Medicines Directive (EUFMD) makes serialisation of licensed drug products in Europe a legal requirement from early 2019, while a second-wave of track-and-trace regulations are set to come into effect in the US from next year.
But while these regulations are beginning to receive pharma’s attention, contract development and manufacturing organisation (CDMO) Recipharm believes industry is mostly unaware of what this means and is unprepared for the scale and complexity needed to conform.
“The new regulations have the potential to significantly impact product supply and we expect to see increased demand for specialist outsourced services as the EU deadline looms closer,” Kjell Johansson, Recipharm’s president of manufacturing services Europe told in-Pharmatechnologist.com.
“The impact of the regulations will reach all corners of the industry, ranging from manufacturing through to marketing and package design and dispensary.”
Recipharm itself expects 85% of its own production to require serialisation, and therefore upcoming challenges are high on the CDMO’s agenda, driving serialisation investments of around €40m ($44m) over the next few years including direct technology investments with Marchesini, SEA Vision and TraceLink, announced last week.
Marchesini and SEA Vision will provide hardware and software for serialisation at levels 1 (device level), 2 (line level) and 3 (site level), while TraceLink’s Life Sciences Cloud will act as a level 4 central repository for Recipharm’s enterprise serialisation management and global tracking needs.
“We believe that they represented the best solution for our customers businesses', delivering a future proof reliable system which is good value for money and high quality,” said Johansson. “Fundamental to our preparations is the need to ensure we have state-of-the-art technologies in place well ahead of the deadline.”
As such, the CDMO plans to implement serialisation services for its customers free-of-charge from the time its processes are operational until the legal requirements come into effect to “ensure seamless compliance,” according to Johansson.
“We believe we are amongst the leading CDMOs with respect to serialisation and our innovative cost model will mean that all of our customers can participate and be prepared well ahead of the deadlines for no upfront payment.”