The implementation deadline of the EU Directive 2011/62 is approaching.

Together with you, we ensure a smooth transition of the statutory requirements required by 9 February 2019. From serialized labels to Tamper-Evident labels to combination solutions: We support your serialization project!

The EU Directive 2011/62 in brief

In the European Union, pharmaceuticals will be subject to traceability. From February 2019, pharmaceutical companies will have to provide the drug packs with two safety features.

Almost all Rx drugs and high risk OTC drugs are affected. A randomized, single-pack serial number is applied to the package together with other components as a 2D data matrix code. This "pharmaceutical serialization" by means of individual coding enables the authenticity test of each individual package.

In the pharmacy, the code is scanned and verified before the drug is dispensed. To this end, the pharmaceutical companies must first report the data requiring verification to an IT system implemented by the pharmaceutical associations. In addition, the pharmaceutical packs are to be equipped with a tamper protection. This ensures that the medicinal product packaged by the manufacturer is actually present in the packaging. The European Union has launched the EU Directive 2011/62 / EU and has made it more specific by Regulation (EU) 2016/161.