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Mandatory marking of a number of medical products

Legal Digest News
The Government of the Russian Federation has supplemented the list of goods subject to mandatory marking in the monitoring information system.

The following categories of goods have been added to the list:

  • Biologically active supplements (Decree No. 886 of the Government of the Russian Federation dated May 31, 2023);
  • Wheelchairs (Decree No. 885 of the Government of the Russian Federation dated May 31, 2023);
  • Disinfecting agents – skin antiseptics and perfume and cosmetic products with antimicrobic action (Decree No. 870 of the Government of the Russian Federation dated May 30, 2023);
  • Medical devices – hearing aids, air purifiers, coronary stents, computer tomographs, etc. (Decree No. 894 of the Government of the Russian Federation dated May 31, 2023).

Each category of goods includes a number of products that are assigned a nomenclature classifier established in the Decree of the Government of the Russian Federation (indicated in the text above). If your product is assigned a classifier from the list, then such a product is subject to mandatory marking.

In this case, starting from September 1, 2023, companies need to submit an application for registration in the information monitoring system "Marking of goods", posted on the portal "Honest Sign" (hereinafter – IS). This has to be done within 7 calendar days from the date of the need to carry out activities for the turnover of goods.

After registration, it is necessary to configure your own software for information interaction with the IS and send the appropriate application to the system operator. The duration of the procedure is 15 calendar days from the date of registration.

Further, an agreement is concluded between the IS operator and the company to obtain marking codes that appear in the system and are subsequently placed on the goods. The transfer of goods between the participants will be carried out on the basis of universal transfer documents issued through the electronic document flow system.

Please note that the terms of the introduction of marking vary depending on the type of product (for example, for medical devices, it is October 1). The beginning of mandatory marking is not yet a prohibition on the turnover of unmarked goods. The system of mandatory marking and tracking of goods is implemented in several stages: first, registration with the operator, then the application of codes for goods and entering information into the system, then the prohibition of turnover without marking.

Administrative and criminal liability is provided for violation of the requirements of legislation in the field of marking of goods. More details about the scope of liability are reflected in the table below.
Type of offense Scope of punishment

Administrative liability (art.15.12, 15.12.1 of the Administrative Code of the Russian Federation)

  • Production, introduction into turnover or sale of goods without marking;
  • Violation of the marking procedure
Imposition of a fine:
  • for officers – in the amount of 5,000 - 10,000 rubles with forfeit of the objects of the offense;
  • for legal entities – in the amount of 50,000 - 300,000 rubles with forfeit of the objects of the offense

Criminal liability (Article 171.1 of the Criminal Code of the Russian Federation)

Production, acquisition, storage, transportation or sale of goods without marking, or turnover of such goods using knowingly false identification means for marking. Punishment for officers if the cost of unmarked goods amounted to more than 400,000 rubles:
  • a fine of up to 400,000 rubles or in the amount of the convicted person's salary for a period of up to 2 years
  • compulsory labour for up to 3 years
  • imprisonment for up to 3 years and payment of a fine of up to 80,000 rubles or in the amount of the convicted person's income for a period of up to six months
Punishment for officers if the cost of unmarked goods amounted to more than 1,500,000 rubles:
  • a fine of up to 700,000 rubles
  • compulsory labour for up to 5 years
  • imprisonment for up to 6 years and payment of a fine in the amount of up to 1,000,000 rubles or in the amount of the convicted person's salary for a period of up to 5 years

In the matters of the compliance with legislation in the field of product marking, please contact Acsour specialists.