Developments

Falsified Medicines Directive, what you need to know

A new national and European system, giving patients further protection from the threat of counterfeit medicines came into effect last week (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.

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.

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