Safety Features for Medicinal Products for Human Use: Delegated Regulation (EU2016/161)
The European Parliament and Council has recently approved and published the Delegated Regulation (EU2016/161) in the Official Journal of the EU. The Regulation supplements the Falsified Medicines Directive (FMD) and introduces two mandatory safety features that will allow medicines to be verified and authenticated:
a unique identifier (a 2D data matrix code and human readable information) to be placed on medical products that can be scanned at fixed points along the supply chain;