The total share of experimentally labeled medicines will reach 10% of the Russian medicine market

| By | Drug Marking, Roszdravnadzor
Pharmaceutical Regulatory

Federal Service for Surveillance in Healthcare of the Russian Federation (also known as Roszdravnadzor) has published data related to the experiment aimed to control labeling (identification) signs and to monitor circulation of certain types of drugs for medical use. In accordance with the data, in the initial phase of the experiment labeling will cover more than 60 types of drugs, including 10 trade names of drugs for the treatment of high- cost ICD codes diseases, and more than 30 trade names of drugs from the list of vital and essential medications. The total volume of drugs to be labeled with the beginning of the experiment will reach about 10% of the market share.

23 medication producers, 4 largest pharmaceutical distributors, more than 30 healthcare organizations and more than 250 medicine retail organizations, including pharmacy chains of a federal and regional scale, have expressed their willingness to participate in the pilot project. As the experiment is being conducted, the number of participants will increase.
Initially, the experiment is supposed to be carried out in six regions of Russia (Moscow, Moscow region, St. Petersburg, Nizhny Novgorod region, Novgorod region, Belgorod region), then, after the software revision and expansion of the technical capabilities, it will be gradually expanded to all subjects of the Russian Federation, as well as to some less accessible areas with an unstable connection to the information system resources.

During the experiment, preliminary testing and evaluation of major organizational and technological solutions generated by the medicine traffic monitoring system will be conducted. Also, within the scope of the project, optimal technological requirements and solutions, as well as the necessary changes and amendments to the normative legal acts of the Russian Federation, regulating the sphere of circulation of medications will be adopted. Further decisions on the implementation of the Russian monitoring system of circulation of medicines will be made, considering the results of the experiment.

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