Questions around Upcoming Drug Labeling System in Russia

| By | Drug Label, Drug Supply, Russian Pharma
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The Association of Russian Pharmaceutical Manufacturers is extremely concerned about the industry’s low current readiness for the industrial exploitation of a drug labeling system from January 1, 2020, and for drugs of group 7 high-cost nosologies from October 1 of this year. This condition will inevitably lead to destabilization of drug supply in the Russian Federation.

The ARPM together with other industry associations appealed to the Government of the Russian Federation and the Administration of the President of the Russian Federation to convey information about the risks associated with the unreadiness of all participants in the experiment to launch the labeling. In response, a letter came from the Ministry of Health with general phrases.

The text says that “the Ministry of Industry and Trade of Russia prepared and forwarded for approval to the interested federal executive bodies and LLC Operator – Center for Development of Advanced Technologies (CDAT) a draft resolution of the Government of the Russian Federation On Amendments to the Annex on the Movement Monitoring System for Medical Use, which provides for provisions setting the length of the verification code to 44 digits.”

Viсtor Dmitriev, General Director of the Association of Russian Pharmaceutical Manufacturers, stressed that “until now, pharmaceutical manufacturers do not understand what scheme to work: either to follow Decree No. 1556 of 12/14/2018, establishing an 88-digit cryptocode and increasing defects, or waiting for a new legislative act with the hope of a decline in both the signs in the cryptocode and production defects”.

The start of the overall labeling is scheduled for January 1, 2020, and the official summing up is scheduled only for February. It is advisable to first analyze the results of the experiment, and after eliminating all the comments and defects, implement the system.

Victor Dmitriev noted that “ARPM sent a letter to the address of the Deputy Chairman of the Government of the Russian Federation M.A. Akimov, in order to sum up the intermediate results, including before the start of the mandatory labeling for 7 HCN on October 1, however, received a formal reply from the Ministry of Health.”

In addition, the expert is surprised by the conclusion of the Director General of the Operator-CDAT, Dmitry Alkhazov, who draws conclusions about the readiness of the Nizhny Novgorod region to the circulation of crypto-labeled drugs throughout the distribution chain – from the manufacturer to the end consumer using only 230 packages tested, which is a drop in the ocean of total pharmaceutical market.

Also, Victor Dmitriev said that “it is alarming that Anton Kharitonov, head of the Pharmacy department of the CDAT, is resigning at the finish line of the experiment and becomes an independent labeling expert, and as the saying goes, do not change horses in the middle of a stream.”

Therefore, the closer the start of the next year, the more acute are the questions for which the pharmaceutical industry does not have answers: when will the technical documentation be approved? What is the final length of the cryptotail? Will parliamentary hearings be scheduled? Will there be a detailed analysis of the work done? And is it worth postponing the start of labeling of drugs for an indefinite period until the elimination of acute problems?