Since 2007, when Turkey mandated drug pack identification and aggregation and France required the use of a data matrix code to identify all drug packs dispensed in pharmacies, regulations have been appearing throughout the world to battle against counterfeit drugs. These regulations have paved the way forward for major changes in the pharmaceutical industry that will gradually lead to a fully fraud- and counterfeit-proof global supply chain.
Drug pack serialisation, as defined today by the EU Falsified Medicine Directive, is the tree hiding the forest for several reasons: many countries are undergoing a comparable approach, aggregation is very likely to follow immediately afterwards and a number of applications will derive from mass serialisation in the future.
The first step to implementing serialisation is the in-line printing of the relevant code and information on each unit pack. The Turkish and French pharma plants’ early requirements revealed the risks and difficulties linked to in-line printing of a 2D code and it took three years to deal with them.