The Association of Russian Pharmaceutical Manufacturers sent a letter addressed to the Chairman of the State Duma of the Russian Federation Vyacheslav Volodin with a request to introduce a stop time for the period of restrictive quarantine measures for the introduction of drug labeling from July 1.
Manufacturers contact the Association because of difficulties encountered in preparing for the launch of the mandatory drug labeling system.
Most of the ARPM member companies finalize the work on equipping the production lines with the necessary equipment and testing the federal state information system for the drug movement monitoring. However, many of the ongoing processes for launching the project are failing due to the fact that specialists from companies supplying equipment for commissioning cannot come to Russia due to the introduction of quarantine measures to prevent the spread of coronavirus. Russian experts, too, cannot travel abroad to accept individual items of equipment and undergo training, and to gain practical skills in working with this equipment.
In this regard, the industry is asking for a “stop time” for the preparatory period before the end of restrictive and quarantine measures. “To add a period of stop-time to July 1, so that we have the opportunity to set up equipment properly and move on,” said Victor Dmitriev, ARPM Director General.
Due to the obstacles mentioned above, it is risky to put the system into commercial operation from July 1, 2020, as the adjustment of equipment is postponed for an indefinite period. And starting the system without commissioning will lead to system failures and destabilization of drug supply in the Russian Federation. Manufacturers hope that their appeal will find understanding and a quick solution from lawmakers. Uninterrupted supply of medicines to the population should be not only guaranteed, but also ensured.