“State Duma Group Recommends Delaying Fines For Violations When Introducing Drug Labeling”


An IWG meeting was held on Wednesday, June 3, 2020, which was attended by representatives of the Center for the Development of Advanced Technologies, the Ministry of Industry and Trade, Ministry of Health, manufacturers, Pharmacies and pharmacy chains. It has It has been confirmed that labelling of medicines is compulsory in Russia after July 1, 2020.


“Today We have one question on the agenda: from July 1, the mandatory labelling of drugs We should begin in Russia. …- the marking was postponed in relation to the initial terms by two and a half years already – twice we made a decision about the postponement. The last time this decision was made here, in the State Duma, last fall, when we were convinced that there was not a sufficient degree of readiness of the industry for labeling, ”  First Deputy Head of the faction “UNITED RUSSIA” on legislative activities, Andrei Isaev stated.


Andrei Isaev voiced concerns about cheap drug segments owing to imported substances and reconfiguring the marking system of all market participants which impacts manufacturers, distributors and medical organizations participating in the labeling system. There are no changes being made to the legislation regarding the timing of labeling however, many parliamentarians believe that a system of measures is needed that will ensure safe entry into the labeling system i.e. administrative responsibility in the initial stages of labeling goods.


“In our recommendations to the Government, we will suggest that Roszdravnadzor not apply administrative responsibility, fines for those organizations that, due to objective reasons related to the COVID epidemic, have not managed to do something and will have violations on labeling issues in the coming months, ”Isaev communicated.


The interfactional working group of the State Duma will propose a number of measures to the Government regarding cheap drugs available in the market so as to make a decision on soft loans at a preferential percentage of organizations producing cheap medicines and to introduce a zero customs duty on the import of pharmaceutical substances.


Many specialists representing foreign companies were not able to travel to Russia and make the required adjustments of the marking system to foreign drugs because of the pandemic. “Therefore, we will offer both the operator, the Center for the Development of Advanced Technologies, and the Ministry of Industry and Trade to conduct targeted work with individual companies to reconfigure the system,” he said.

Russia will also amend the law on the circulation of medicines to ensure the possibility of unimpeded importation before the mandatory labeling is carried out. “In the event that foreign manufacturers have something stalled with the marking, they will be able to carry out the substitution at the expense of the goods, which was produced earlier and which can be sold legally in the Russian Federation without marking. We will make relevant proposals.”