Are you compliant with the Falsified Medicines Directive?

Are you compliant with the Falsified Medicines Directive?

Published by Mark Cramer on 27th Aug 2019

What Is It?

The Falsified Medicines Directive is legislation passed by the European Union Parliament and this aims to increase the security of the manufacturing and delivery of medicines across Europe. Protecting patients and preventing falsified medicines from entering the supply chain.

The Directive 2011/62/EU introduces safety features such as a unique identifier and an anti-tampering device on the outer packaging of medicines. Which means pharmacies need to adapt to be able to check the compliance of any medicine they sell. But what does it mean in practice?

How Will It Affect You?

Over 400,000 pharmacies in Europe will be impacted by the Falsified Medicines Directive European Directive, ratified by the European Parliament in 2016 and effective in February 2019. The reason for these measures are to prevent the introduction of illegal medicine into the legal supply chain. The pharmaceutical industry must be compliant and consolidate their medicine traceability practices to fight a rise in medicine counterfeiting.

When?

By February 2019 every pharmacy within the EU will need to be equipped with a barcode scanning solution. To comply with the requirements, pharmacies will be required to check the anti-tampering device to ensure it is intact prior to dispensing, change the status of the pack in the National Medicines Verification System from “active” to “inactive-supplied”- This is where the Zebra barcode scanning comes in, the 2D barcode is scanned which communicates with the National Medicine Verification System.

What Next?

This is where the DS9900 Series Hybrid Presentation Imager comes into place, it is built purposely for medical labs and pharmacies, the perfect solution to keeping you compliant. It improves workflow efficiency and accuracy. Workers get first-time, every time capture of the many types of barcodes found in the lab including small, high density, curved and colour-coded.

The DS9900 is not the only solution scanner, Zebra have a full range of Hospital and Retail Pharmacy scanners including;

For more information visit www.thelabelman.co.uk/healthcare.