The Russian Federal Law No. 425-FZ (decree No 1556) which came into effect October 1, 2020, states that to track supply chain activity, certain pharmaceutical products must be serialized. Unlike the EU’s serialization requirements under the 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
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 (four characters from the GS1 characters set 82) and crypto code (44 characters: symbols, numbers, and 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:
- 14-digit Global Trade Item Number (GTIN)
- Serial number (SN): 13 symbols of numeric or alphanumeric sequence of the Latin alphabet; can be random
- Crypto key
- Crypto code