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;
  • tamper evident features on the pack.
All features will need to be in place in the supply chain by early 2019. The Commission has issued a Q&A document :

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