Serialization for Russian Federal Law No. 425-FZ

As a leader in serialization and traceability solutions for a variety of industries, OPTEL is well positioned to help pharmaceutical companies comply with Russian Federal Law No. 425-FZ (decree No 1556), which states that in order to track supply chain activity, certain pharmaceutical products must be serialized by January 1, 2020. Unlike the EU’s serialization requirements under FMD, Russian regulations apply to a wider range of pharmaceutical products. These include:

  • 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, lower and upper-case 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-digit
  • Serial number (SN): 13 symbols of numeric or alphanumeric sequence 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

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 are 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 ruble. Codes can be stored outside of Russia with an L4 solution, like OPTEL’s Verify Platform.

 

OPTEL SOLUTION

OPTEL will be ready to support all our customers that must comply with the Russian regulations by the January 2020 deadline. We have a variety of options for you, depending on your unique situation, and our team of experts can help you navigate the best solution for your lines in order to remain compliant while also meeting your production criteria.