A new EU Directive to address the threat of fake medicines

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The "Falsified Medicines Directive" (FMD) a new and more robust EU legislative framework will be rolled out from February 2019 to ensure better protection of public health and patient safety.

The main reason behind this change is the increasing fraudulent production of medicinal products which can potentially put at risk patient health and damage the confidence of patients, consumers and healthcare professionals in the safety of these products.

According to the new directive all prescription human medicinal products and some non-prescription medicines must be packed with two additional safety features:

  • a unique identifier (UI), displayed as a 2D barcode
  • an anti-tampering device (ATD) that ensures the packaging has not been previously opened.

The list of categories of medicinal products subject to prescription which shall not bear the safety features are set out in Annex I of Regulation (EU) No 2016/161, while the list of medicinal products not subject to prescription which shall bear the safety features are set out in Annex II of the same Regulation.

There is an exemption for medicinal products already in stock which can be sold or distributed until the end of the expiry date on the packaging, with a transitional period lasting until 2024. So in these cases a recall or repackaging is not required.

Three countries, namely: Belgium, Greece and Italy, that already operate a national system for identification of medicinal products will have a longer transition period for the implementation of the directive. The additional period is of up to 6 years, however Belgium has formally renounced the extension and confirmed the application of the new rules as of 9th February 2019.

Here you can find an infographic by pharmaceutical-journal.com that explains in detail how FMD will work

The new Regulations put in place by the EU Directive represent an important improvement over the current system.

Some of the main benefits are :

  • Higher level of health and safety protection for EU patients
  • More secure trade of medicinal products throughout European countries
  • Alignment of EU legislation with significant technological and scientific progress in this sector
  • Stricter pre- and post-market controls
  • Better coordination between EU countries to ensure proper vigilance in this area
  • Improved monitoring capabilities for manufacturers.

Overall this change in legislation will enable a strinct control of authenticity for medicines at the unit level (individual pack) thus greatly improving patient safety and confidence.

The use of new 2D matrix codes will also allow storing product identification data (for example ID code, batch number, expiry date and serial number ) directly on the packaging using pictograms instead of printed text which greatly improves automatic checks of large batches.   The new EU Directive and its technology implementation via 2D matrix codes or other innovative solutions clearly represent a big step forward into the digitalization of products information in healthcare.

That’s why myHealthbox has invested since the very beginning in a full featured digital leaflet solution that enables a range of functionalities that are simply impossible to implement in a paper product, our solutions fulfill the requirements set forth by the EU Directives in this area and complement any solution adopted to comply with the FMD.

We aim to change digital communication in the healthcare, ask us how we can help you Contact us

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