News & Events

Falsified Medicines Directive Update

By aisltd, Friday, 15th January 2016 | 0 comments
Filed under: Industry News.
The Falsified Medicines Directive (FMD) incorporates a number of initiatives to safeguard the pharmaceutical supply chain in Europe. Read the latest update here.


Among these are "safety features" for all medicines entering the supply chain in the EU, while also stating "Those safety features should allow verification of the authenticity and identification of individual packs, and provide evidence of tampering". 
Basically this means that all medicines distributed in Europe need to be marked with a unique, 'machine readable' serial number, a 2D barcode is used in most cases. This unique number (barcode) is then traced from the factory, through the distribution network, all the way to the pharmacy/hospital where it will be scanned and verified at the point of dispense. 

The FMD Delegated Act is now published and will become law in most European countries in March 2016. Manufacturers, Distributors and Pharmacies will then have 3 years to implement their serialisation (or Track and trace) system, to ensure they are complying with the directive.  


The legislation also states that all medicines must have a 'tamper evident' safety feature.  Herma have developed a new machine specially designed to apply TE labels to medicinal products. If you would like to speak to one of our Engineers about the Herma 362 TE machine, please contact us.