A new national and European system, giving patients further protection from the threat of counterfeit medicines comes into effect tomorrow (Saturday 9th February 2019). Throughout Europe, medicine packs will have enhanced tamper-proof measures and will now carry a barcode with a unique serial number so that each pack can be scanned in a pharmacy. It will be checked against a central database to ensure the product is legitimate before handover to a patient. Established and managed by the Irish Medicines Verification Organisation (IMVO), the new national system provides an additional layer of security to protect the supply of medicines at pharmacy and patient level. Ireland is now in compliance with the EU Falsified Medicines Directive (FMD), which provides more safeguards and security to ensure Irish patients will continue to have absolute confidence in the medicines they receive from their pharmacy.
According to Pat O’Mahony, Chair, IMVO, “Setting up this advanced and robust verification system is a significant undertaking as a result of over three years of collaboration by the key Irish stakeholders including pharmaceutical manufacturers, parallel distributors, wholesalers as well as community and hospital pharmacists. Substantial work and investment has been required by everyone in the medicines supply chain to have the system up and running and in place as appropriate to the legislation coming into effect.
“Although there has been no risk or reported incidents at pharmacy level from counterfeit or falsified medicines in Ireland, other countries have had issues so this new system provides further security and protection for Irish patients now and into the future. Counterfeit medicines can pose serious risks to health, as there is no guarantee of their quality or safety,” he says.
The initiative has involved the collaboration of over 2,000 pharmacies, hospitals and wholesalers in Ireland who distribute dispense over 95 million prescription medicines every year, as well as the manufacturers who make the products. Each pharmacy now has a scanner to check each pack before it is dispensed to the patient. The scanner connects to a central database of prescription-only medicines manufactured, distributed and supplied for sale in Ireland.
Patients will see the new safety features appear on medicine packs as they come onto the market this year. Each pack will have a:
Speaking today, Minister for Health Simon Harris, TD, said: “The purpose of the regulation is to improve patient safety and maintain confidence in the safety of medicines supplied to patients. Nothing in the new regulations seeks to alter the existing legal and regulatory responsibilities of persons authorised to place medicinal products on the market or supply them to the public. It will apply to manufacturers, wholesalers, pharmacy owners and pharmacists equally. This new national system provides further security and protection for Irish and European patients now and into the future.”
The system is based on providing an alert if the barcode is not identified when scanned. A clear protocol then follows to investigate these alerts, involving the location where the pack was scanned, the manufacturer, the Health Products Regulatory Authority (HPRA), the IMVO and its European counterpart, the European Medicines Verification Organisation (EMVO).
For the next number of months, medicine packs with and without the individual serial number will be available at the same time as the existing stocks are gradually replaced by new packs with safety features. There is also a period of time allowed to bed in the new system across the country so alerts will be monitored and managed without any impact on medicine supply during this ‘use and learn’ phase.
IMVO advises that purchasing prescription-only medicines from the internet or other unauthorised sources is illegal and there is a high risk that these products are counterfeit, not safe for use, and do not contain the active ingredient required to make the medicine work. When you receive medicines from your pharmacist, always listen to their advice and follow the steps outlined in the package leaflet.
For Further Information:
Weber Shandwick PR: (01) 679 8600
Siobhan Molloy / Jo Twamley: (086) 817 5066/(085) 143 8320
Notes to Editors
IMVO is a not-for-profit organisation established by the key stakeholders across the medicines supply chain in Ireland to manage the national medicines verification system for Ireland:
IMVO has worked extensively over the last three years with the relevant State organisations to ensure a successful system is in place. This includes close collaboration with the Department of Health, the Health Products Regulatory Authority (HPRA), the Pharmaceutical Society of Ireland (PSI) and the Health Service Executive (HSE). There has also been extensive collaboration with the European Medicines Verification Organisation (EMVO) and other national medicines verification organisations to ensure that the system across Europe is ready for the 9th February deadline.
This new initiative is part of the European Commission’s Delegated Regulation (EU) 2016/161 on Safety Features on Medicinal Products for Human Use. The Delegated Regulation supplements the Falsified Medicines Directive 2011/161/EU, by setting out detailed rules for the safety features appearing on the packaging of medicinal products for human use.
IMVO is part of a European-wide network of national medicines verification organisations, all operating national databases connected together via an EU Hub managed by the European Medicines Verification Organisation. This advanced and robust verification system ultimately captures the data of all medicines legitimately manufactured and supplied across Europe.
Counterfeit medicinal products are now officially known as ‘falsified medicinal products’ under EU medicines legislation. Falsified medicines may contain ingredients which are of poor quality or in the wrong dose.