The system for implementing the EU-FMD has been productive about five months. The EMVO has just reported that 40% of pharmaceutical manufacturers in Europe are still not or not fully connected to the system. It calls on the national authorities to punish such infringements. However, some of the manufacturers are already preparing for the next challenge.
For all pharmaceutical manufacturers that are also active in the Russian market, the implementation of the Russian track and trace requirements represents a major challenge. Compared to the EU-FMD, the requirements are much higher. In addition to the manufacturers of prescription drugs, the OTC manufacturers now also have to find a track and trace solution. But the initiative does not only ensure drug safety. The data collected is also of interest.
Manufacturers and contract manufacturers must find solutions for implementing the Russian traceability requirements. And these are far more complex and comprehensive than the EU-FMD. The crypto code law in Russia adds another level of security to the drug supply chain by encrypting the code.
The Russian code
Unlike the DSCSA or the EU-FMD, the hurdle for the implementation of Russian regulations is even higher. Not only the complexity of the code plays a role, but also the language is a certain hurdle for all involved parties, as many of the documents are currently only available in Russian. Before a solution can be worked out, it must be translated.
Due to the size of the code, hardware and software must be adapted along the supply chain. The code has a higher data density than the European 2D Datamatrix code. Here the standard coding is 24×24 or 26×26 modules. The data density in the Russian code is up to 40×40 modules. However, the codes must be accommodated on a similar printing surface, so that higher demands are made on both scanner and printer than for the European code. In addition to GTIN, serial number and EXP, the Russian code must also contain two Application Identifiers (AI 91 and AI 92), which are transformed using cryptographic methods. However, it is no longer necessary to include the batch number. It only has to be applied in human-readable format. This would make it possible to use pre-serialised labels. This does not work in the EU because of the batch number.
CRPT and Big Data
As early as 2018, the CRPT (Center for Research in Perspective Technologies) was deployed as operator of the Russian Drug Circulation Monitoring System (IS MDLP). The CRPT intends to invest a total of three billion dollars to support the Russian government’s drug safety initiative. The investment is worth it. A fee will have to be paid by the manufacturers for each crypto code generated. In addition to this source of income, new sources of income will arise from the industry data collected in the company. While the CRPT emphasizes that its activities are monitored and regulated by the government, even without using proprietary data, there are opportunities to make market forecasts and sell them.