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EU Commission Delegated Regulation (EU/2016/161) / Falsified Medicines Directive (FMD)
From Department of Health
Published on
Last updated on
From Department of Health
Published on
Last updated on
In 2011, the European (EU) Commission published a new directive, 2011/62/EU, which is known as the Falsified Medicines Directive (FMD).
This Directive amended EU Directive 2001/83/EC on Human Medicinal Products and introduced new measures to combat the risk of falsified medicines entering the supply chain. It requires all pharma companies to put a unique 2D barcode and an anti-tampering device on packs of prescription medicines for the EU market.
From 09 February 2019, people supplying medicines to patients must verify that the safety features of those medicines are in place by scanning the 2D barcode and checking the integrity of the anti-tamper device.
The National Safety Features Oversight Group comprising of the Irish Medicines Verification Organisation (IMVO), the Department of Health, the Health Products Regulatory Authority (HPRA), the Pharmaceutical Society of Ireland (PSI), the Health Service Executive (HSE) and the Private Hospitals Association (PHA) continues to oversee progress with FMD implementation in Ireland. FMD has been in a ‘use and learn’ phase for pharmacies, hospitals and wholesalers in this country since February 2019 due, in part, to the impact of Covid-19 and Brexit.
The National Safety Features Oversight Group following consultation with all relevant stakeholders, have agreed a plan for ending use and learn on a phased basis concluding on 30th May 2022. This final extension of the use and learn phase takes into account the impact of the Omicron wave of Covid-19 and dates of interim phases have also been adjusted accordingly.
Please see IMVO website for other key dates and further information.
Key Stakeholders will continue to work together as a priority to ensure Ireland meets its obligations under this important Directive.
First Published: 8 February 2019
First Published: 6 February 2019