SERIALIZATION OBLIGATION

Reliable serialization systems at pharmaceutical companies must combat the life-threatening trade in counterfeit medicines worldwide. With the EU Directive 2011/62 / EU, the European Union has irrevocably published its answer to life-threatening counterfeit medicines. Result: compulsory serialization of prescription medicines!

The basic requirement to counter counterfeiting is to ensure that each package is given a unique serial number combined with a product ID (GTIN / NTIN / PPN), a lot code and an expiration date. All this information must be encrypted in a 2D data matrix code. The serial number may also not be easily reproducible. Furthermore, each package must be made tamper proof. This means that it must be clear that the packaging has already been opened. The combination of these two measures should be the key to safe medicines and should strengthen consumer confidence in the pharmaceutical industry and their products.