Wednesday, 9 December 2015

Pharma Businesses - 2018 EU Falsified Medicines Directive - Are you ready?

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


To combat the global threat of counterfeit medicines, authorities around the world are tightening the supply chain to stamp out illicit goods, by using 2D barcodes and clever software to keep track of what is manufactured, shipped and delivered throughout the pharmaceutical industry.

In simple terms it means that every pack of medicine or pharmaceutical product will have to have a unique identifier applied at the point of manufacture and 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 barcode (a 2D Datamatrix) 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. To satisfy the regulatory authorities for the new directives will take a lot of effort, and if you don't have a system in the warehouse, a lot of paperwork.
A "smart" Warehouse System will certainly be a must have to record and validate this level of information and will at the same time deliver the operational efficiencies through the use of 2D barcode scanning, WiFi technologies and configurable software to automate all the warehouse and inventory processes.

Dexterity WMS already supports this functionality, including being able to configure the 2D barcodes to suit your business, smart scanning and validation on goods receiving through order pick & pack to despatch with a full traceability record for every single transaction, so that a complete audit trail is available for immediate inspection .

Dexterity WMS will also enable you to validate expiry dates, track and locate product recalls down to individual batch numbers and achieve all this with no more staff than you have now. 2018 seems like a lifetime away but the industry reports that most companies are already behind with their preparations to implement the EU directives.  If you need to get ready, consider Dexterity WMS as part of your supply chain solution for the warehouse.

For businesses who already have the scanning and data capture capability in place, but may require the ability to print or re-print label to this specification, NiceLabel Control Centre Enterprise is the prefect product to enhance existing label printing systems.


NiceLabel Control Centre Enterprise ensures a centralised traceability and management layer for labelling, required in medical, pharmaceutical, biotechnology, manufacturing and in several other industries. It ensures compliance with regulatory requirements or your company internal security and quality standards.  For more information on Dexterity WMS or NiceLabel Control Centre Enterprise call the sales team at Barcode-IT for a full explanation of how you business can achieve full regulatory compliance without having to change the WMS or ERP system.


Written by Jim Southern, specialist in warehouse management at Barcode-IT.  To ask questions about this article or find out how barcodes with a Dexterity Smart Warehouse can transform your business, call 01200 441977 or email Jim @ Barcode-IT today.  Or do some research at www.warehouse-it.co.uk

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