Here, Christoph Krähenbühl, senior director of Excellis Europe, explains the challenge new Russian traceability regulations present to the pharma industry, and how all participants in the supply chain must properly prepare to ensure that they become compliant within this new environment.
Regulation
On 1 January 2020, Russia will introduce a new, compulsory system for tracking pharmaceuticals from manufacturer to end user. This new legislation should be considered alongside wider global efforts to enhance quality control and put in place protection against fake and counterfeit medicines. Recent reports evidence the devastating impact of counterfeit medicines around the world, making the need for fully traceable pharmaceuticals more relevant than ever before.
While Russia’s approach to compulsory serialisation follows that of many other regions, there are technicalities and complications specific to Russian regulations that must be addressed by companies in the pharmaceutical supply chain, if they are to remain compliant next year. Here, we explore the issues pertinent to organisations looking to commence or continue in the new Russian market, including background to ‘track and trace’, reporting to Russian authorities, the unique new cryptographic approach and the challenging timeline faced by all parties involved.