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EU Falsified Medicines Directive: Barcodes

The EU Falsified Medicines Directive (FMD), which has been introduced to reduce the risk of counterfeit medicines in the supply chain, comes into force on February 9th, 2019. Requiring all 150,000 community pharmacies throughout the EU to implement the FMD. From this date, all prescription medicine packs must have a unique code which will be placed on the packaging in the form of a 2D barcode (data matrix). The unique code will be held in a national database and there will be a requirement for pharmacies to scan the barcode on every pack to confirm that the unique serial number is held in the database. All packs will also have a tamper evident seal and there is a requirement to check that the seal is intact prior to dispensing. The EU legislation requires the scan and tamper to take place at “the time it’s supplied to the patient”.

The benefit of this directive is to eliminate counterfeit medications before they reach the consumer. It also provides for better tracking of the medication if there is a recall. These scans will also become a part of the patient record which becomes part of the facility’s database. Should a recall come, the code can be searched for and the consumer can be identified in the database and can then be contacted for corrective treatment. Records will also indicate which staff member provided treatment along with the date and time.

For updated information please visit the National Pharmacy Associations website: