A draft government resolution amending the regulations for the circulation of labeled products has been published on the portal of draft regulatory legal acts. The document affects several product groups, including medical devices, and introduces a new accounting object—a “set.” The amendments pertain to Resolution No. 894 of May 31, 2023.
What is a “set” and how does it differ from group packaging?
Previously, the concept of group packaging existed—a grouping of identical products with the same code (for example, 10 bundles in a single box). Now, a “set” is being introduced—a specially formed collection of various labeled products that may belong to different categories (including pharmaceuticals).
Key changes for medical devices
– The new accounting object is a set. It is assigned its own identification code (KIN) and can be handled as a single entity.
– Simplifying document flow: submitting a set code to the Chestny Znak system is equivalent to submitting data on all products included in it. Simply scan one code.
– Kit marking – the Data Matrix code must be applied not only to the consumer packaging of each product, but also to the kit itself before it is sold.
The procedure for registering a set
To create a kit, it must be pre-registered in the national catalog of labeled goods. The application must contain:
– TIN of the company;
– full name of the set;
– codes of all incoming goods (if absent – refusal);
– the number of units of each product.
If the kit includes products from other groups (for example, medications), the system verifies that they have been released into circulation. If this information is missing, the kit’s registration will be rejected.
Aggregation and dissolution: flexibility in circulation
It’s possible to disassemble a set. For example, if only one item from the set is sold, the system automatically records the disassembly, and the remaining items retain their status for further circulation.
Aggregation rules (combining products into packages) have also been clarified and extended to kits. Data on the relationship between codes is stored, ensuring full traceability without opening the packaging at every stage.
Recommendations for business
For companies working with medical devices, the following will be required:
– adapt accounting systems (1C, etc.) to work with the new type of codes – KIN;
– review warehouse and production processes for forming sets;
– control the status of goods included in the set (they must be put into circulation).
New opportunities
The introduction of the “set” concept doesn’t so much tighten controls as it creates a legal and convenient mechanism for selling sets of goods. Previously, traders had to either violate the system’s logic or scan each code multiple times. Now, this problem is technically easily solved.
Benefits of the new approach
– reduction of labor costs for warehouse operations – working with one code instead of several;
– the ability to offer customers kits in full compliance with the law;
– simplification of document flow during shipment and acceptance. To ensure a trouble-free transition, it is recommended to test the work with the kits in advance in the test circuit of the marking system and update the internal regulations.
