Stages for implementation of drug labeling system in the Russian Federation

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According to the plans, the implementation of system for labeling medicinal products will proceed on a stage-by-stage basis. Since this is a complex project, it starts with an experiment. From February 1 to December 31, 2017, the labeling will be carried out on voluntary basis. Experiment participants will fine-tune all technologies, conduct preliminary testing and evaluate the effectiveness of the main organizational and technological solutions in order to make the system mandatory in 2018.

The preparations were held in January – April. This May marked the testing of a prototype for the automated system to track the movement of medicinal products from the manufacturer to the end consumer (testing of information interaction, registration and description of medicinal products, basic business processes).

The automated system began to operate on June 1 and started to register the personal accounts of its first organizations. These organizations began to label their medicinal products and submit data on their movement. In other words, all basic business processes of the system became available in June.

The functionality of the system will expand from June to August, and from September 1, the system will start to ensure a full-fledged inter-agency information exchange.

During 2018, within a framework of already mandatory labeling program, the system is scheduled to gradually connect all market participants, and by January 1, 2019, it is planned to label all medicinal products released to the Russian market.

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