In order to keep the patients safe and avoid falsified or fake medicines getting into the pharmaceutical supply chain in Europe, the EU Falsified Medicines Directive (Directive 2011/62/EU) set a number of measures that include:
A European standardised logo to help identify legal online medicines
Safety measures to check the authenticity of the medicine packs before dispensing
From February 2019, most prescription medicines to reach the market must have these safety measures:
An anti-tampering device (ATD) or seal to make sure the package hasn’t been opened or altered after its manufacture
A unique identifier (UI) which is a 2D barcode with the information such as the product code, batch number, expiry date and serial number.
This means manufacturers must place these safety measures on every pack of medicine put in the market and upload the data to a repository system via the National Medicines Verification System. In Ireland the national repository system is the Irish Medicines Verification Organisation or IMVO.
Since the FMD regulation requires medicines data to be verifiable at any point in the supply chain, including pharmacy and hospital dispensing, certified software providers like Quick Pharm Solutions can assist in the process.
Medicine packs should be scanned and verified for authenticity at the point of dispense. If the data matches the information in the system, that particular pack can be decommissioned to avoid duplication and can then be given to the patient.
When this can’t be authenticated, the system will alert the pharmacist or healthcare organisations so it can be investigated.
Simplify FMD compliance challenges
FMD software and hardware solutions, like EasyFMD, are used to help make the medicines serialisation and verification process accurate and efficient with precise and fast barcode scanning technology.
EasyFMD helps your business being fully FMD compliant while saving you time and resources and most importantly, helping patients .