2018 EU Falsified Medicines Directive

Is your business prepared for the 2018 EU Falsified Medicines Directive?

To combat the global threat of counterfeit medicines, authorities around the world are tightening up the supply chain with new regulations designed to try and stamp out these illicit goods. The solution involves using 2D barcode labels and intelligent software to keep track of all items moving through the pharmaceutical industry.

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In simple terms it means that every pack of medicine or pharmaceutical product will require a unique identifier applied at the point of manufacture which can be tracked through the whole supply chain. The unique identifier will need to contain the product code, batch number and expiry date as well as its serial number to uniquely identify the pack. This data will also need to be contained in a 2D barcode which can be scanned and tracked throughout the supply chain.

So if you are a pharmaceutical manufacturer, distributor or pharmacy there will be a requirement to record, capture and share this information.

What are the implications for my business?

  • Label designs need to be updated to comply with the new regulations therefore any manufacturers of pharmaceutical will need to ensure that their labelling software is capable of printing 2D barcodes onto labels. We have several low cost design & print packages available on our Label Software pages.
  • The 2D codes can only be scanned by a 2D Imager scanner therefore distributors, resellers and vendors need to ensure their barcode scanning equipment is up to date. We have numerous compatible hand held mobile devices and plug in style barcode scanners available from our hardware pages.
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If you need any help or advice on this matter then please feel free to contact our experienced sales team who will help choose the right upgrade solutions for you.

Deadline: July 2018

For more detailed and comprehensive information about this directive please refer to the relevant European Commission webpage: https://ec.europa.eu/health/human-use/falsified_medicines_en