NANOLEK has successfully introduced all the necessary marking hardware and software for production. The stage of active testing of messaging in the drug monitoring system with partners has completed. Thanks to the measures taken, the company managed to start the planned process and release a marked first commercial batch of the orphan drug for the treatment of type II mucopolysaccharidosis (included in 12 HCN) in the amount of 1,664 packs on November 21.
Alexey Ryzhiy, IT Director, NANOLEK:
“Today, we successfully exchanged data in the productive circuit of the drug movement monitoring system and marked the product at the factory. This suggests that our production part has been completed and successfully tested; therefore, we are fully prepared for the implementation of this large-scale project. We are at the very beginning of the journey, but the first big step has been taken.
Today, we are pleased with the result and the work done, but if you look back, of course, the process was not that smooth, and we faced a number of difficulties. Any IT system may fail even within a single company. In this case, we are dealing with a global project that is simultaneously being implemented in the entire distribution chain in the Russian Federation so that all the processes operate like clockwork - more time and practice are required.
I’m glad that the State Duma initiated a stage-by-stage implementation of the mandatory marking process from July 1, 2020; the postponement gives substantial hope for 100 percent preparation of all participants in the process in order to avoid unpleasant outcomes, as a result of which, first of all, the consumer may suffer.”
A pilot drug-marking project in the Russian Federation started on February 1, 2017. From October 1, 2019, the marking of medicinal products for 7 HCN is mandatory.
According to the data provided by the website of the Federal Service for Surveillance in Healthcare, as many as 27 international generic names of medicines of List 7 of HCN have been registered and approved for medical use in Russia. In total, twenty-one domestic manufacturers, sixteen holders of registration certificates for foreign medicines, and sixteen wholesale organizations supply the medications of this category to the Russian market.