Is the Pharma Supply Chain Ready for True Medicine Traceability? October 31th, 2018

Is the Pharma Supply Chain Ready for True Medicine Traceability?

More than 400,000 pharmacies in Europe will be impacted by European Directive 2011/62/EU, ratified by the European Parliament in 2016 and effective in February 2019. The intent of this measure is to prevent the introduction of illegal medicine into the legal supply chain. This means pharmaceutical industry players must consolidate their medicine traceability practices to fight a rise in medicine counterfeiting. The new Directive 011/62/EU introduces safety features – such as a unique identifier and an anti-tampering device on the outer packaging of medicines – that will require pharmacies to adapt their process to check the compliance of any medicines they sell. Compliance with FMD regulation will enable pharmacies to improve their stock management procedures and prevent falsified medicines from entering the supply chain. Every pharmacy within the EU will need to be equipped with a barcode scanning solution by February 2019.

Requirements for Pharmacies

FMD will be introduced in 32 countries. In order to comply with the requirements of FMD, community pharmacies will be required as part of the dispensing process to check the anti-tampering device (ATD) to ensure it is intact prior to dispensing and change the status of the pack in the National Medicines Verification System from "active" to "inactive—supplied". This involves scanning the 2D barcode on each pack and communicating with the National Medicine Verification System.

 Falsified Medicines – what's the solution?

All packs of almost all prescription medicines will have to have two safety features; visual tamper-evident seals or packaging and unique identifiers (serial numbers) in 2D barcode. 

Potential Benefits of the Falsifies Medicines Directive

FMD is beneficial for patient safety, pharmacy stock, and patient information.

  1.  Patient safety benefits, there will be reduced risk of falsified medicine given to patients as well as the accuracy and date checking will be made easier.
  2. Pharmacy stock benefits include the improved stock management, reduction of manual data entry, and accurate pack-level data for all products
  3. The main patient information benefit is the enablement of generating patient-specific information efficiently and effectively. 

Zebra scanning technology helps pharmacies to achieve compliance by enabling them to scan, record manage and verify all medications they hold on stock and dispense to patients. Contact BlueStar today to comply with the necessary equipment to comply with the FMD.


Samantha is BlueStar's Digital Media Specialist, and the primary contributing writer for VartechNation. Previously, she has worked as a Public Relations Associate and a Social Media Manager.