Discussion paper on facilitating the implementation of the EU Falsified Medicines Directive with GS1 Standards

The purpose of this paper is to facilitate the discussions for a harmonised implementation of the EU Falsified Medicines Directive using global standards and moving away from national coding systems.


EU legal framework on pharmaceutical GS1 Global FMD Readiness Paper cover image 220pxtraceability The EU has a strong legal framework for the licensing, manufacturing and distribution of medicines. At the end of the distribution chain, only licensed pharmacies and approved retailers are allowed to offer medicines for sale, including the legitimate sale via the internet. In July 2011, the EU strengthened the protection of patients by adopting a new Directive on falsified medicines (FMD).

The European Commission defines ‘Falsified medicinal product’ as:

“Any medicinal product with a false representation of:

(a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients;

(b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or

(c) its history, including the records and documents relating to the distribution channels used.

This definition does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights.”

The ultimate goal of this Directive is to prevent falsified medicines entering the legal supply chain and reaching patients. It introduces harmonised safety features and strengthened control measures across Europe.