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Falsified medicines have always been a major concern for the European Union (EU) as they represent a serious threat to public health and safety. To address this concern, the European Commission (EC) has released the Falsified Medicines Directive (FMD), which details the safety features designed to protect European patients and ensure that medicines are safe and of good quality. The Delegated Regulation will apply as of February 9, 2019.  

Manufacturers, wholesalers, and contract manufacturing organizations (CMOs) will soon have the obligation to guarantee the authenticity of any rescription drugs by identifying individual packs and checking whether the outer packaging of medicines has been tampered with.


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