In an article published by CPHI Online, Staffan Widengren, director corporate projects at Recipharm, looks back on Recipharm’s approach to serialisation ahead of the FMD deadline and discusses the company’s future plans.
In February 2019, the new Falsified Medicines Directive (FMD) legislation for serialisation came into force, designed to guard against counterfeit medicines entering the supply chain. With no one-size-fits-all solution available for pharmaceutical companies to implement, many firms faced the challenge of altering legacy systems and processes in order to comply with the legislation before the FMD came into effect. In addition, data exchange and onboarding customers were key challenges for CDMOs.
Many companies underestimated the complexity of implementing serialisation solutions.