Recall that the Association of Russian Pharmaceutical Manufacturers as early as February 1, 2021, turned to the Ministry of Industry and Trade following the results of a round table held on January 27 at the RF CCI with a proposal to amend the standard form of an agreement for the provision of labeling services to subjects of drug circulation, approved by order of the Ministry of Industry and Trade of Russia dated 11.09.2019 No. 3381, in order to introduce responsibility of Operator – Advanced Technology Development Center, for failures in the operation of the DMM system, leading to significant financial losses for manufacturers.
Finally, a response from the authority was received, dated February 26, 2021 and signed by the Director of the Department of the system of digital labeling of goods and legalization of product turnover E.G. Priezheva. We quote it in full: «In terms of fixing sanctions for the Operator for violations of the monitoring system, we inform you that the proposals of the Association of Russian Pharmaceutical Manufacturers have been taken into account and, if necessary, will be taken into account as part of the work carried out by the Ministry of Industry and Trade of Russia to improve legislation in the field of labeling goods with identification means.»
“From this I can conclude that the Ministry of Industry and Trade does not yet see the need to introduce the Operator’s responsibility and reduce the losses of the pharmaceutical industry,” ARPM CEO Victor Dmitriev commented on the answer. «What a pity! And it seemed to me that it was the Ministry of Industry that should defend the interests of industry. »
The answer has been received, but it cannot satisfy the industry. ARPM will continue to seek the normative consolidation of the Operator’s responsibility and are confident that we will not be alone in this fair demand.