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Falsified Medicines Directive (FMD)

"From February 2019 the Falsified Medicines Directive (FMD) will be rolled out in Europe to address the threat of fake medicines and will impact the entire supply chain..."

Under the Falsified Medicines Directive (FMD) Delegated Regulation (EU2016/161), all new packs of prescription medicines put on the market from 9th February 2019 will have two safety features.

  1. A unique identifier or 'UI' (a 2D data matrix code and human readable information) which will be placed on medical products that can be scanned at fixed points along the supply chain

  2. Tamper evident features (anti-tampering device or 'ATD') on the pack.

    Unique Identifier: The UI is a unique 2D data matrix barcode (FMD barcode) made up of four key elements (shown right). If the pack size permits, it will also carry the same information printed in text adjacent to the barcode.
    Must include: Product code, unique serialisation number, expiry date and lot/batch number.

For further guidance on safety features please visit the FMD MHRA Inspectorate here.

Are you ready for FMD compliance?

If you are a manufacturer of medicines, (or the marketing authorisation holder), an NHS hospital or a pharmacy then FMD compliance affets you! If you are in the UK, Weyfringe can help you with your FMD requirements with Easylabel software to help you to design your 2D data matrix barcodes, a range of thermal barcode and label printers to print your 2D UI barcodes, and Axicon 2D barcode verifiers to verify your printed 2D data matrix barcodes. (All of our FMD devices are able to generate, print or read GS1 compliant barcodes).

Frequently Asked Questions - Falsified Medicines Directive

Q. What type of FMD label printer do we need?

A. In many cases pharmaceutical companies use 300dpi printers, however the introduction of GS1 Unique Device Identification specififcations and EU/UK FMD requirements means 600dpi printers are becoming more popular particularly for printing 2D data matrix barcodes.

Q. What type of FMD software do we need?

A. Easylabel software – Create your FMD labels and 2D barcodes on screen.

 

Q. Can the product code, serial number, expiry date and lot/batch number be included in just one barcode?

A. Yes, the creation of GS1 UK compliant barcodes for FMD labelling is an easy 4-step process with Easylabel software.

 

Q. Can we log and track FMD label data with Easylabel software?

A. Yes – Easylabel’s Print History Console function allows you to see who printed what and when, aiding traceability.

 

Q. What version of Easylabel software do we need to create FMD labels?

A. Minimum Easylabel Gold to print 2D barcodes, or Easylabel Platinum to enable the Print History Console function.

 

Q. Can user sign-on be controlled with Easylabel software?

A. Yes – Enable the User Sign-On function to control who can log in to Easylabel software.

 

Q. Can barcodes be graded upon verification?

A. Yes – Axicon barcode verifiers can identify a non-conforming barcode in seconds and as well as highlighting the areas to be corrected. Simple pass/fail screens can be selected or more detailed explanations for comprehensive FMD labelling quality control.

 

Q. Can we print onto silver labels?

A. Yes – the correct label and ribbon combination is critical to the quality of the print that you will achieve, as well as what sort of conditions your labels are expected to cope with (e.g exposure to light, heat, friction, adverse weather conditions). Call 01642 490121to speak to one of our label and ribbon experts, or complete our custom label quotation request form.

If you would like to arrange a FREE no obligation demonstration please follow the link below or call 01642 490121

Arrange a demonstration