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ERS Solutions Pharmacy FMD Compliant 2D Barcode Scanner

ERS and Newland your Gateway to Pharmacy FMD Compliance

UK pharmacies will be expected to scan the 2D Barcode on medicines before they are dispensed.

The EU Falsified Medicines Directive (FMD) is implemented into UK law from 9th February 2019.

FMD will start in all EU member states from February 9, 2019. This includes the UK, which will remain in the EU until March 29.

From this date all new packs of prescription medicines in Europe will have to bear two new safety features, an anti-tampering device (ATD), and a unique identifier (UI) in the form of a 2D Barcode, which will be registered on a database called the European Medicines Verification System (EMVS).

In order to comply with the requirements, every community pharmacy in the UK will, at the time of supplying a prescription medicine to a patient, be required to check the ATD and scan the barcode.

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What is the Falsified Medicines Directive?

The directive introduces harmonised EU measures to fight medicine falsification, ensure medicines are safe, and that the trade in medicines is rigorously controlled. Measures include:

  • New, compulsory safety features – including a unique identifier and an anti-tampering device – on the outer packaging of medicines
  • A common, EU-wide logo to identify legal online pharmacies
  • Tougher rules on the import of active pharmaceutical ingredients
  • Strengthened record-keeping requirements for wholesale distributors.

Source: European Commission

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What Will Pharmacies Need to Do?

Each pharmacy will need to acquire at least one 2D barcode scanner, and potentially an extra workstation, to be able to ‘decommission’ medicines from the EMVS.

In the decommissioning process, a medicine will need to be authenticated: have its UI scanned and verified against a UK safety database called the National Medicines Verification System, or NMVS, before it is handed to a patient. This is so a pharmacist can verify it is a genuine medicine, and not a counterfeit.

To do this, new pharmacy software will be required, either as an update to existing patient medication record (PMR) systems, or as a stand alone system. Standard operating procedures (SOPs) will also have to be updated, to incorporate the authentication barcode scan into the current dispensing process, and of course, staff training will have to take place.

contact ers Please contact us on: sales@ersltd.co.uk for further information or give us a call on
+ 44 (0) 1234 855 300 for all requirements.
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