13 December 2018

Prepare for the Falsified Medicines Directive

By User

The EU Falsified Medicines Directive (FMD) will come into effect in February 2019 and will impact over 400,000 pharmacies throughout Europe.

In the UK, it will impact 15,000 community pharmacies, 260 acute NHS hospitals, 190 private hospitals, 1,200 dispensing doctors, 7,500 GP practices and surgeries, 1,500 authorised wholesalers/distributors 790 market authorisation holders, and 66 million patients (Royal Pharmaceutical Society). Any company in the Pharmaceutical industry needs to be ready for the changes brought by the FMD.

The purpose of the FMD is to prevent illegal medicines from entering the supply chain, which could include medicines with the wrong ingredients or that have been tampered with.

Zebra have the answer with the TC25 Rugged Smartphone.

The FMD will require that all new medicines will have to include two new safety features.

A Unique Identifier (UI)

The UI requires the use of a 2D barcode, which means your pharmacy may need to upgrade from 1D scanners

Anti-Tampering Device (ATD)

This is a sticker that ensures that the product package has not been opened before sale. The medicine cannot be sold if the ATD is broken.

The FMD will require pharmacies to authenticate products at the time of sale by visually checking the ATD and by scanning the UI for verification and decommissioning.

What does this mean for your business?

You will need to make sure that your scanning technology is up to date. Upgrading to 2D scanners will not only help with complying with the FMD but will also future proof your business as barcode technology continues to advance.