The European Falsified Medicines Directive (EU FMD) comes into effect in February 2019, which only leaves a couple of months for pharmaceutical companies and contract manufacturing organisations (CMOs) to achieve compliance. TraceLink’s Global Drug Supply Safety and Traceability Report, which includes a survey of over 600 respondents, found that while 94% of CMOs felt ‘somewhat’ or ‘very prepared’ for serialisation, 42% had not begun preparing.
Many [businesses] have failed to appreciate the preparation time required.
In this Q&A with CPhI Online, Staffan Widengren, Director Corporate Projects at Recipharm, discusses this survey in detail, including what CMOs should be focusing on and the value-added opportunities that serialisation brings.
Widengren will be speaking on this topic at FutureLink Munich, 5-7 June 2018, delivering a keynote presentation on the ‘Final countdown: focus areas for a CDMO before February 2019'. https://www.tracelink.com/futurelink