What’s in it? Where is it from? Serial numbers on medicines increase product safety.
An unambiguous serial number informs about the origin and supply chain
How can the pharmaceutical industry be protected against the damaging counterfeiting of medicines? How can consumers be sure they are receiving an original product with the designated active substances, and only with these? The question was seriously discussed in the US, Europe and other countries. The solution was similar in all cases: an unambiguous identification of each individual packaging unit should be effected.
With the Guideline 2011/62/EU (Falsified Medicines Directive) of 2011, the European Union determines that almost all prescription medicines shall in future be issued with an unambiguous serial number. This 2D Data Matrix Code can ideally include information on the producer, the batch number, a serializing number (based on chance) as well as the expiry date and can be scanned. If required, then there may also be a national number for payment, integrated in this serial number.
The information in the 2D Data Matrix Code and the tamper-resistant seal together guarantee that the product is an original product, the origin of which is unambiguously verifiable together with the supply chain
In addition, the guideline requires the caps to be produced with tamper-resistant seals. Thus the consumer can be sure that the product is an original product and can also check the supply chain. This however requires a reliable track-and-trace system. Should there be a lack of documentation in only one spot, then the whole system is worthless.
The producer is therefore obligated to handle the packaging procedures and changes, including the data base of the generated codes together with the serial number. The pharma logistics companies face a challenge of a different kind, not only computing the numbers at each point in the supply chain, but also to make them accessible for commerce and industry. This is the only way in which the tracking of the individual units is possible.
Should the market also extend into other countries, then the data flow has to be compatible with those data systems in the other countries. The US and Turkey have come to the same conclusions regarding serializing and the contents of the codes, yet there are still minor differences. Even the members of the EU do not always agree completely. France, Italy and Belgium have had greater demands as Germany for example. Even that has to be taken into account when tracking the supply chain.