Russian Track & Trace System
Russian Track & Trace System: Additional Costs or Opportunities?
? What is the implementation timetable?
Oing: The Russian authorities know that the system they are seeking to establish is very complex. The regulations will therefore apply only to drugs for seven especially lucrative types of disorders at first. The deadline for this first stage is January 1, 2018. One year later, the FSIS DCM rules will be applied generally to “especially important” medicines. And a further year after that, from January 1, 2020, all medicinal products for human use will have to be serialized. At the moment, pilot projects involving 16 pharma manufacturers and a total of 30 medicines are already under way.
? But the timetable is tight, isn’t it?
Oing: It is certainly a challenge, and one that should be taken seriously. Representatives of the Russian authorities have already warned the pharma companies not to drag their feet with serialization and GxP projects in order subsequently to claim that insufficient time was allocated. There is a certain sense of expectation on the part of the Russian authorities, which should not be underestimated. Stipulations cannot be met simply by equipping packaging lines with additional devices. Implementation entails developing and interlinking entire information systems.
? How well is Atlantic Zeiser prepared for the Russian challenges?
Oing: The ability to comply with the very extensive requirements in this country depends to a large extent on the flexibility of the software. We designed our Medtracker from the outset so that it can adapt to as yet unknown, complex serialization regulations. The Russian stipulations are no exception. The extensive interface library that makes Medtracker so remarkable also helps us when it comes to linking various databases, institutions, authorities, and manufacturers within a country. Of course, the time required to configure the interfaces in an individual case is not to be underestimated, especially given the need for fine tuning.
? What about the hardware?
Oing: Atlantic Zeiser designed the software architecture of Medtracker so that it can be connected to existing, even multi-vendor hardware. Medtracker is able directly to control a variety of hardware components, such as camera and printing systems and other units. This means that there may be no need to invest in hardware if the existing equipment is fundamentally able to fulfill requirements.
? What is to be done if a track and trace module has to be newly integrated?
Oing: We can plan and implement a single-provider software and hardware solution. At the Interpack fair, for instance, we were showcasing a new track and trace module that can perform serialization and, if necessary, be equipped with a check weigher and tamper evident labeler, all within a small footprint – with a built-in Medtracker interface, of course. We are therefore well equipped to stay on top of even the Russian challenge.