New product labelling rules, specific aspects of medical product labelling in Russia

​The Russian lawmakers keep consistently implementing the new product labelling system. New regulations affect almost every segment of the domestic market and every imported good. The main goals the lawmakers pursue are: organization of control over the product movements and prevention of introduction of falsified, low-quality and counterfeit goods into the market.

For this purpose, a unified catalogue that includes every product and a unified system that provides a mechanism for assignment of unique codes to product units, storage and transmission of all the data concerning the circulation of products are created. 

The Federal Law no. 487-FZ of 31 December 2017 that lays foundation for large-scale product labelling entered into force on 1 January 2019. Currently, this system is being gradually implemented in several market segments. Ultimately, the new system should be introduced in the entire market.

The system should be considered as an exhaustive resource (catalogue) that can be divided in major product groups, for example footwear, clothing, medicines and tobacco products.

Thanks to this system, consumers will be able to check whether the products they buy were legally produced.  To check that the product is the original one, the consumer will need to scan the label with a specialized mobile app. Examples of such applications are QR scanners and the free official app named “Proverka tovarov” (“Goods checking” in Russian) recommended by the Russian Federal Tax Service.  This app works on iOS and Android mobile devices.

For every major product grouping, there will be a catalogue with data on every product and description of product features. Responsible for the creation and maintenance of the catalogue are operators of information systems. Accordingly, for every market segment there will be an independent operator running an independent information system.

The operator of an information system is a legal entity established in the Russian Federation. Its functions are: creation, development, management and usage of an information system ensuring centralized generation of labelling codes with the help of Russian cryptographic technologies. In addition to the already mentioned tasks and among other things, it verifies, registers and stores data provided by the parties involved in the circulation of goods (Order of the Government of the Russian Federation no. 791-r “About the approval of the blueprint for the product labelling system of the Russian Federation based on the means of identification” of 28 April 2018).

The Operator uses the data submitted to a specialized Internet website by the parties involved in the circulation of goods (manufacturers, holders and owners of registration certificates - for goods made outside of the Russian Federation, other legal entities and sole proprietors involved in the circulation of goods) to derive and to store in a predetermined order the information about every product unit and every action performed upon the product unit before withdrawal from circulation. In the case of medicines the process would look as follows:

• The manufacturer (if the product was made in the Russian Federation) or the holder/owner of a foreign manufacturer’s registration certificate and/or their representative offices and other parties involved in the circulation of goods apply for registration on a dedicated Internet website.  In the application, they must provide key data about the legal entity or the sole proprietor.
  Important! Among other things, the applicant must have an advanced certified digital signature and appropriate software because the legal merit of virtually every transaction must be confirmed with a signature.
  Within ten days after data submission on the website, some parties involved in the circulation of medicines also must submit an application prepared on a paper document according to established rules with the Federal Service for Public Health Supervision (Item 24 of the Order of the Government of the Russian Federation no. 1556 of 14 December 2018);

• The application must be processed within 14 days. If the application is accepted, the applicant can log into the personal account.

• Then, a description of the product must be submitted to the information system. Lists of persons obliged to perform corresponding actions and of required data vary between product categories. In the case of medicines, for example, these persons are the manufacturers (if the product was made in the Russian Federation) and the holders/owners of registration certificates and/or their representative offices (if the product was made outside of the Russian Federation)
  The list of data that must be registered in the information system can be found in Annex no. 2 of the Regulation on the Supervision of the Movements of Medicines Occurring for Medical Use that was approved by the Order of the Government of the Russian Federation no. 1556 of 14 December 2018.

• For medicines, operators of information systems provide the issuers registered on the website with the checking codes with the help of issuance registration devices. (Order of the Government of the Russian Federation no. 1556 of 14 December 2018)
  According to the Order, to the issuers belong:

1. for medicines produced in the Russian Federation: medicine manufacturers responsible for the packaging stage of medicine production during which they attach means of identification to the secondary packaging (for consumers) of the medicine (and if no such packaging is present, to the primary packaging of the medicine);
2. for medicines produced outside of the Russian Federation: holders or owners of the registration certificate for the medicine (hereinafter referred to as the registration certificate);
3. for medicines produced outside of the Russian Federation: Russian representative offices of the foreign companies holding or owning the registration certificate.
   The issuance registration device is a cryptographic hardware and software complex (cryptographic security controller) providing the issuers of the means of identification with checking codes and compiling and registering legally significant data about the means of identification attached to the medicines packaging in the supervision system.
   According to the Order of the Government of the Russian Federation no. 1557 “About specific aspects of the implementation of a system for supervision of movements of medicines occurring for medical use” of 14 December 2018, the issuers must place with the operator of an information system an application for a device registering the issuance of the means of medicine registration or an application for remote access to such devices (within 21 days of registration with the supervision system). The implemented technical solution is chosen by the issuer of the means of identification.  Within 30 calendar days after receiving the application, the operator of an information system must either provide the party involved in the circulation of medicines submitting the application with the device or grant it remote access to the device. In order to provide for a seamless usage of the device, above-mentioned parties involved in the circulation of medicines conclude agreements with the operators of the supervision system where the conditions of device provision and of its unpaid statutory maintenance must be enunciated;

• After the issuer has received either the issuance registration device or remote access to such a device, they may apply for checking codes. The operator of an operating system must provide a list of codes (global identification serial numbers of a product unit and checking codes) for medicine packaging within two hours of application receipt and register them in the supervision system using an issuance registration device.
  Regulations on supervision of products movements (for example, “Regulation on the Supervision of the Movements of Medicines Occurring for Medical Use” approved by the Order of the Government of the Russian Federation no. 1556 of 14 December 2018) specify the sequence of encoded data that must be included in the label. 
  A means of identification contains a labelling code. The labelling code must contain a unique identifier and a checking code.

• On a production line, data included in the means of identification represented as a two-dimensional bar code are printed or labelled on the package (a label must be attached to the packaging in a way that makes removal of a label impossible). Normally, the secondary packaging is marked. When none is present the primary packaging is labelled. A product group code an issuer of product group codes generates and prints/labels onto the packaging must be applied to the transportation (tertiary) packaging.
  Until 1 October 2019, the issuers must ensure that the means of medicine identification be applied to the primary packaging (in the absence of secondary packaging) or to the secondary one.

• After the product has been labelled, it may be released into circulation.
  If the product was manufactured in the Russian Federation, the required information must be registered in the supervision system within five working days of the end of the packaging stage of medicine production by the party involved in the circulation of medicines that dispenses the medicine into packages (required data are listed in Item 1 of the Annex 1 of the Regulation approved by the Order of the Government of the Russian Federation no. 1556).
  However, if samples of the medicine are needed for quality control, the data must be provided by the party involved in the circulation of medicines that selects the samples and, after the quality control procedure ends, the party that packages the medicine.
  If the product was manufactured outside of the Russian Federation, the data must be submitted by the party involved in the circulation of the products that holds or owns the registration certificate or by the Russian representative office of the foreign company that holds or owns the registration certificate after:

1. the quality control stage of the production process ended  (within 20 days of the stage end)
2. If the product needs to be imported to the Russian Federation first, the above parties provide the required information after the delivery of medicines to the Russian Federation (within 45 days of delivery). After that the product must undergo various checks and procedures conducted by the customs office of which the customs notify the supervision system.  After the customs check ends and an import permission is obtained, the product is deemed to be released into circulation on the domestic market.
   Now, every time the product changes hands this will be reflected in the system maintained by the operator of the information system.

• Withdrawals from the circulation must also be reflected in the system.
  Parties involved in the circulation of medicines that sell medicines in retail stores and provide other persons with medicines carrying means of identification use cash registers to upload data about the withdrawal of medicines from circulation.
  Parties involved in the circulation of medicines that do not sell medicines in retail stores, but provide other persons with medicines (for free or at a discount against a prescription) must submit data about the withdrawal of medicines from the circulation to the supervision system using withdrawal recorders provided by the operator of the supervision system. Operators of information systems provide withdrawal recorders free of charge. Legal relationships between operators of information systems and the above parties concerning the provision and usage of such devices must be regulated with an agreement.
  If the product enters into circulation again, the required data must be re-uploaded to the system, whereby the code assigned to the product remains unchanged.
  At the moment, the OOO Operator-CRPT acts as the operator of the information system for supervision of medicines movements occurring for medical uses. Its activities are carried out over the unified national system for product labelling and tracking Tchestny ZNAK (Order of the Government no. 2828-r of 18 December 2018).

Key conclusions

• During labelling procedure, unique codes are printed or labelled onto every product unit. To facilitate registration, there exist codes for consignments (boxes, pallets).
• Russian manufacturers may release the product into circulation only after required data were submitted to the Labelling Information System prior to sales commencement.
• Importers release the products into circulation after required data were submitted to the Labelling Information System prior to any customs procedures. When customs procedures are accomplished and a permission for the import of labelled products to the Russian Federation is obtained, the product is deemed to have been released into circulation.
• Products must carry labelling codes to be presented for the actual customs control. Outside of the Russian Federation, the product may be labelled either at a production facility or at any moment during the sorting and packaging stage. Labelling codes may be requested at Labelling Centres.