PR: 24 months, 24 photos: security solutions in the context of Delegated Regulation (EU) 2016/161

The countdown is running: On February 9, 2019 - in 24 months - the transition period for pharmaceutical manufacturers to implement Delegated Regulation (EU) 2016/161 on counterfeiting security for medicines will end. By that time, every prescription drug will have to be provided with an unique serial number in the form of a 2D code (DataMatrix) and an anti-tampering device on the packaging to protect patients from counterfeit medicines.

The 24 pictures illustrate what customized product and brand protection to safeguard the supply chain can look like, covering the aspects of first-opening indication, protection against tampering and counterfeiting at all security levels (overt, semi-covert, covert and digital) as well as identification, tracking & tracing. When manufacturers combine these features, this will result in complex security labels that successfully put a stop to the counterfeiters' game.

This is absolutely necessary because counterfeit medicines pose a common threat and an international challenge. The World Health Organization (WHO) estimates that in industrial countries up to seven percent and in developing countries between 30 and 70 per cent of all medicines are fakes.

As the profit margins in this case are significantly higher than those generated with drugs or in cigarette smuggling, counterfeiting syndicates with global activities are increasingly involved as well. The legal distribution chain, for instance, is circumvented by means of internet pharmacies and products are falsely labeled in terms of their identity, ingredients or origin. Affected by counterfeiting are all forms of administration, such as pills or tablets, infusions, injections, ointments and liquid solutions, be they generic or patent-protected, or prescription or non-prescription drugs.