The Ministry of Industry and Trade has confirmed that the introduction of mandatory drug marking with two-dimensional digital code in Russia will not be postponed and will begin on January 1, 2020.
A pilot drug marking project was launched in 2017. The marking of drugs from the list of high-cost nosologies became mandatory from October 1, 2019, and the marking of all drugs will become mandatory from January 1, 2020.
According to new labeling rules, a Data Matrix code on the medicine packaging is mandatory. The turnover of marked products will be reflected in a special monitoring system – it will be possible to track the path of each package from the manufacturer to retail.
In addition, using the application on a smartphone, customers will be able to verify the legality of the drug and notify regulatory authorities of suspicious specimens.
Despite the fact that initially the state planned to provide the system for free for manufacturers, the government later approved a tariff of 50 kopecks excl. VAT (approximately 1 US cent) per code. Free code will be issued only for medicines worth up to 20 rubles (app. 30 cents).
And recently, the Russian Union of Industrialists and Entrepreneurs stated that drug labeling system is not ready for operating. In particular, due to an increase in the percentage of defects, shortcomings in a single directory-catalog of drugs, difficulties in exchanging data between participants in the process with the federal information system.
However, the Ministry of Industry and Trade reminded that the deadlines were set by federal law, and a support mechanism was created to facilitate the implementation of a monitoring system for pharmaceutical manufacturers.