GS1 standards for Pharmaceuticals

One of the key objectives of the European Directive on the prevention of the entry into the legal supply chain of falsified medicinal products is to ensure product integrity and authentication of medicines (ie. safety features and product serialisation). It will encompass a harmonised unique identifier across Europe. 

The Delegated Acts on safety features (Regulation 2016/161), were adopted on 2 February 2016, and published in the Official Journal of the EU on 9 February 2016. The regulation is explaining the technical details of the EU Falsified Medicines Directive (FMD), setting up the first “end-to-end verification system” for drugs across the world. The deadlines for implementation of the requirements across Europe is 9 February 2019, and in 2025 for Belgium, Italy and Greece. Implementation at national level can be completed before the end of these transition-periods.