EU Commission Delegated Regulation (EU/2016/161) / Falsified Medicines Directive (FMD)
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From: Department of Health
- Published on: 10 February 2020
- Last updated on: 11 February 2022
- Introduction
- Final Extension of FMD Use and Learn Period Ireland
- Minister for Health brings EU Commission Delegated Regulation on Safety Features on Medicines into effect
- EU Falsified Medicines Legislation – Update on National Arrangements for Implementation
- S.I. No. 36/2019 - Medicinal Products (Safety Features On Packaging) Regulations 2019
Introduction
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.
Final Extension of FMD Use and Learn Period Ireland
Falsified Medicines Directive (FMD) use and learn period due to end in Ireland in Q2 2022
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.
Minister for Health brings EU Commission Delegated Regulation on Safety Features on Medicines into effect
First Published: 8 February 2019
EU Falsified Medicines Legislation – Update on National Arrangements for Implementation
First Published: 6 February 2019
EU Falsified Medicines Legislation – Update on National Arrangements for Implementation