Two opportunities and one challenge of the EU falsified Medicines Directive for Label Printers

Starting 9 February 2019 Directive 2011/62/EU, amending Directive 2001/83/EC, commonly referred to as the “Falsified Medicines Directive” (FMD) will generally require that prescription drug medicines in the EU/EEA will have to be equipped with two safety features: 1) a unique identifier, which is a serialized data-matrix code with human readable information, and 2) a so-called anti-tampering device/tamper verification feature (not specified). The FMD will affect approx. 10.5 million medicinal products a year in the EU/EEA.

Picture of serialization barcodes, http://pharmaceuticalcommerce.com

So for pharmaceutical manufacturers and their packaging producers it is a technical solution to provide a) the unique identifier as serialized data-matrix code with human readable information on a label and b) to provide the anti-tampering device / tamper verification feature by means of a tamper evident label to the packaging of a finished medicinal product in order to be compliant to the regulation. So these two safety features would be two opportunities for Label Printers to enlarge their portfolio.

But the EU-Commission in version 9 of their “QUESTIONS AND ANSWERS paper of the EU-Commission on the SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE” from February 2018 states that the use of stickers to carry the unique identifier is generally not accepted and may only be accepted in exceptional, justified circumstances. So the technical option and opportunity to mark the packaging of a finished medicinal product with a label that contains the unique identifier is now challenged. Pharmaceutical companies and industry associations have approached the EU-Commission to change their viewpoint on this issue. Hopefully, this challenge will be overcome in the near future.

Dieter Moessner, Project Engineer Pharma at pharmaceutical carton board packaging specialist Edelmann (D) will speak on the “EU Falsified Medicines Directive – How to implement serialization and tamper evidence?” at the EUROPEAN LABEL FORUM 2018 in Dublin on 7th June 2018.

Blog by Dieter Moessner, Project Engineer Pharma at pharmaceutical carton board packaging specialist Edelmann (D) will speak on the EU falsified Medicines Directive – How to implement serialization and tamper evidence? at the EUROPEAN LABEL FORUM 2018 in Dublin on 7th June 2018

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