Federal Law No. 425-FZ (decree No 1556)

Regulatory Agency

Ministry of Health of the Russian Federation

Regulation Name

Federal Law No. 425-FZ (decree No 1556)

Deadline

January 2020: unit and case serialization with aggregation and reporting

WHICH PRODUCTS ARE COVERED? 

  • Prescription medications
  • Over-the-counter medications
  • 12 nosologies: medications for rare diseases that are expensive to treat, such as hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, myeloid leukemia, multiple sclerosis, immunosuppressive therapy for organ transplant patients, hemolytic uremic syndrome, juvenile arthritis with systemic onset and mucopolysaccharidosis type I, II and IV.
  • Free samples

Under Russia serialization requirements, the reporting of serialized products takes place through a centralized database called the Federal State Information System for Monitoring Drug Circulation (FSIS MDC). Manufacturers must onboard with the FSIS MDC and report all serial numbers and batch numbers to the centralized system. Along with the information required by U.S. and European regulations (a GTIN and serial number), the Russian regulations call for a crypto key (4 characters from the GS1 characters set 82) and crypto code (44 characters: symbols, numbers, lowercase and uppercase letters from the Latin alphabet).

Each individual unit must be serialized with a 2D barcode that is placed on the box or bottle. This 2D code contains the following information:

  • Global Trade Item Number (GTIN): 14 digits
  • Serial number (SN): sequence of 13 numeric or alphanumeric symbols of the Latin alphabet; can be random
  • Crypto key
  • Crypto code

Currently, the lot information and expiry date do not have to be included in the 2D code.

In addition, aggregation of all product units – the sellable unit to case as well as case to pallet – is required under the Russian law. Each member of the supply chain must report every change in individual batches; for example, how much of the batch remains together and where the removed units went. Furthermore, supply chain trading partners must record and report up to 36 possible “compliance events,” such as unit pack and unpack, which is a considerable increase from the requirements of other global pharmaceutical regulations.

 

HOW IT WORKS

Manufacturers must request crypto codes from the Center for Research in Perspective Technologies (CRPT), which manages Russia’s national track-and-trace system, known as Chestny ZNAK.

Crypto code request and reporting inside Russia

If your company is located inside Russia, CRPT provides a “black box,” which is free and installed locally at each site. The black box can hold up to a maximum of 2 million crypto codes, from one or multiple GTINs.

To make a crypto code request to the black box, you will need a GTIN and SN list. CRPT has indicated that although the request may take up to two hours to complete, 10 minutes is their target timeline to provide the GTIN + SN + CRYPTO.

Crypto code request and reporting outside Russia

The code request process outside Russia is similar to the process inside Russia in many ways: crypto code requests are not batch-based; you will need your GTIN and serial number(s) to make a request; users can manage their own serial number generation; generated serial numbers will be submitted as part of the request to receive their associated crypto tails; and corporate or global serial number management is preferred.

The main differences are that you must use CRPT’s web service to get crypto codes, and the estimated price of one crypto will be 0.5 rubles. Codes can be stored outside of Russia with an L4 solution, such as OPTEL’s Verify Platform.

Cryptocode Russia