So, which are the biggest challenges to fulfill these new regulations? There are several challenges that all parties in the supply chain need to find their solution for.

The first challenge that I would like to address is who will take the additional Cost for this? I did mention this already in the introduction part… There is no main rule here, so it will become a negotiation between the manufacturer and the other partners on how the additional cost will be distributed. However, it might mean that the manufacturer needs to raise their prices and there is a risk that the price is also adjusted, all the way to the consumer/patient. This can be difficult as there might already be signed contracts in place. I think all parties need to look at how to make the information handling as efficient as possible, to keep the additional costs down. This can also develop into a competitive advantage.

The next challenge is the handling of the additional information that is required by the new regulations! With handling I mean create, send, receive, store and trace the information.

To Create means here both to reuse already existing information, but in many cases, it also means to create new information. One example is that each package of drugs needs to have a unique identity, consisting of a combination of the NDC (National Drug Code) and a running number. This unique identity must be printed on each package, but more about that later. There is also a need to have a solution that keeps track of which packages are put in the larger containers all the way up to the delivery level.

As I said above, there is a need for more space to print more information on the package of the drug. This will imply that the labels need to be redesigned or even that a bigger package is needed.

To Send here means to first gather the information required by the regulation and then to create the documents where that must be used. That is the TI, TS and TH. The media for sending the information must be agreed in-between all involved parties that are involved in the information transfer. Each receiver needs to be able to Receive these documents on this media. So, will the media be paper or any electronic format (like EDI or RFID). On top of this the information need to be Stored for six years.

To Trace will then mean that the information needs to be accessible. This can result in very high amounts of information if the volume of transactions is high. But not only that, there are also a need to have a good architecture and good reports. So, to store this on paper format is not optimal. It of course requires a digital solution.