In recent years, laws and regulations have been passed in many parts of the world to mandate the serialization and/or track & trace of prescription drugs. They differ from region to region in many small details. Three principal questions keep recurring, however.
Who generates the serial numbers?
The serial numbers can either be made available by an organization that is subject to a national authority. This was the case in China until now, for example. Or the responsibility lies with the drug manufacturer, who must adhere to certain requirements. With the aforesaid exception of China, as per the current state of affairs the drug manufacturers must deal with this subject themselves.
Serialization or track & trace?
Both terms are frequently used synonymously, but this is not quite correct. Track & trace, i.e. the tracking and tracing at any point of the supply chain requires additional work steps. The serialization of a drug alone does not automatically allow tracing (track & trace). If it is sufficient to print a serial number onto the product and to store and transmit this serial number, this is what is referred to as serialization. That is what is intended in the EU as of 2019. If, in addition to this, the serial numbers have to be documented in packing hierarchies of bundles, packaging cartons, pallets etc., this is in general referred to as aggregation. These aggregation data are then used for better traceability, for example – the track & trace of batches along the logistics chain. Most countries with a serialization obligation require aggregation, but the EU does not, for example.
Where or to whom are the serialized data reported?
At this time, three different approaches to this aspect can be seen. In most cases, the data are reported to a database that is subject to a government authority. This is for example the case in Turkey. In the EU, the central gathering and storage of these data is the responsibility of the pharmaceutical companies themselves. Looking at the current situation, however, one can assume that one or more contractors will assume this task on behalf of all manufacturers, as a central service provider on a national level. In the “American” principle, an electronic pedigree, the so-called transaction statement, will be used instead of a central database. This is a certificate that the manufacturer has to forward to his customers, for example a wholesaler. Without this e-pedigree, no participant within the logistics chain may purchase goods, and he may only pass on these goods with a valid one.In the serialization software MEDTRACKER, all named principles are already implemented and can be adjusted to a country‘s specific requirements or peculiarities with little effort. Thanks to the modular system architecture, the validation effort for smaller, subsequent adjustments is quite small. Even today it is clear that additional regions will follow suit with serialization regulations and that further adjustments will be made to existing regulations by the authorities in the future. The current developments in China are a good example.