What is Serialisation and why is it Important?

1st January, 1970

What is Serialisation and why is it Important?

One of the biggest challenges facing the pharmaceutical industry is counterfeit medicines.  Without suitable regulation this can have a disastrous effect on society. The solution is to amend the latest serialisation updates on all pharmaceutical packaging and labelling products. With the introduction of Near-Field Communication (NFC), serialisation codes could soon be superseded, but now more than ever serialisation is vital for the latest pharmaceutical industry regulations.


Serialisation is the allocation of unique traceable numbers to individual items or sellable units. For pharmaceutical products, this is frequently through QR codes and bar codes containing a unique identifier of data, such as the serial number of the unit, the expiration date and more. Although their function seems simply to generate and manage serial numbers, they are also useful for manufacturers wanting to assemble identical products, as well as for companies to track and trace their items.

Falsified Medicines Directive

Serialisation became a legal requirement in the US in 2017, known as the Drug Supply Chain Security Act (DSCSA). In the EU, the issue has been addressed by the Falsified Medicines Directive (FMD), which is a regulation put in place to stop counterfeit medicines infiltrating the supply chain. Although the decree doesn’t come into effect until February 2019, the FMD outlines every pack must contain a unique identifier in the form of a 2D bar code. This is compulsory for all products supplied within the EU or else they have the right to be decommissioned by wholesalers.   

If you want to find out more, you won’t want to miss the Pharma Packaging and Labelling conference this September in Munich. This conference will provide an opportunity for you to hear from GS1 who standardise barcodes, the European Alliance for Access to Safe Medicines and many more. It’s vital pharmaceutical companies are up-to-date with the latest regulations. For more information, please visit http://www.arena-international.com/pharmapackagingeurope/ or alternatively email us at: events@arena-international.com


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