Countdown to FMD compliance 9th Feb 2019

Apr 3, 2018, by Kevin O'Brien - Category: Healthcare
Implementation deadline is approaching, February, 9th 2019

Are you ready?

The EU FMD deadline is fast approaching. In the Irish context, this means that all prescription medicines sold in Ireland will need to be fully EU-FMD compliant by 9th February 2019.

Implementation of the Falsified Medicines Directive requires many different disciplines. Developing solutions will be a team effort with manufacturers assembling consortia of specialists in coding, imaging, data management and handling. This is a time consuming process, and with less than a year until the deadline, time is running out.

Key Facts about EU FMD

GTIN in 2D Barcode for Serialisation EU FMD

Product GTIN encoded in a 2D datamatrix barcode

The introduction of the European Falsified Medicines Directive means all manufacturers of prescription medicines will be expected to print a 2D datamatrix barcode with serialisation data on medicine packs and these packs then need to be verified at the point of dispense. This requires significant changes for pharmaceutical manufacturers and will require IT development changes in hospitals and community pharmacies.

Benchmark your readiness

GS1 Ireland and our serialisation solution partners, ESP, published the second annual Serialisation Industry Readiness Survey in late 2017. The report focuses on preparations to meet the EU FMD deadline and draws from stakeholders across the industry, including Pharma Manufacturers, Virtual Pharma Companies, Contract Manufacturers, 3PLs, and Wholesale Distributor Repackagers.

The report is a great chance to benchmark your readiness for the EU FMD deadline with industry peers.

Click here to download the report

Tags: FMD, serialisation, pharma,