Developing a robust serialisation programme for the EU FMD
The enforcement of the EU Falsified Medicines Directive (FMD) in February 2019 saw the serialisation of pharmaceutical products become a legal requirement. Designed to improve the security of the manufacture and delivery of medicines supplied to the European market, many pharmaceutical companies did not recognise the complexities involved with implementing a serialisation solution.
Now that the FMD deadline has passed, it is time to explore the additional value that can be gained from new systems and the processes introduced.
Now that the deadline has passed, the industry can look beyond immediate compliance requirements and manufacturers can assess how they can futureproof their offerings and achieve new efficiencies.
Staffan Widengren, director of corporate projects, at Recipharm discusses how the leading CDMO developed its serialisation solution and the key challenges experienced in meeting the FMD requirements. He also explores how the EU serialization requirements vary between the European market and the US market.
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