New rules to fight falsified medicines

A new European Regulation (EU2016/161) requires Marketing Authorisation holders to place two new safety features on the packaging of medicines.

The safety features, which allow medicines to be verified and authenticated, are:

  • a unique identifier (a 2D data matrix code and human readable information) placed on medical products that can be scanned at fixed points along the supply chain
  • tamper evident features on the pack

The regulation comes into force in the UK in 2019, and the safety features must be introduced no later than 9 February 2019.

The MHRA and Department of Health are working with the Europe and supply chain representatives on implementation plans and will publish further guidance as it becomes available.