How the system works
Medicines that carry safety features are commonly known as ‘FMD packs’.
Those who supply medicines to the public in Ireland, including pharmacies and hospitals, have connected their software systems to the Irish Medicines Verification System (IMVS) (via an Internet connection) to enable them to check that FMD packs are genuine before they are dispensed to patients.
Pharmaceutical wholesalers are also required to check FMD packs in certain situations and are also connected to the IMVS.
Manufacturers must print a 2D barcode on each pack containing a product code, batch identifier, expiry date and a unique serial number (collectively known as ‘unique identifiers’). They then upload the information in the barcode to the IMVS via the EU Hub. When the pharmacist or wholesaler scans the 2D barcode, if the details are not found or the status of the pack (i.e. ‘active’ or ‘decommissioned’) doesn’t match the information in the IMVS, an alert is generated. IMVO is responsible for ensuring that alerts are investigated. Depending on the type of alert, the manufacturer and/or the person who scanned the pack that generated the alert may look after this with input from IMVO as required. If a technical or data error cause is ruled out, then the pack is deemed to be a suspected falsified pack and must be reported to the national competent authority for further investigation. The national competent authority for Ireland is the Health Products Regulatory Authority.