Russia Regulations
Russian Federation
STATUS: PUBLISHED/ADOPTED
Authority: Ministry of Health of the Russian Federation
Request Source: Regulation
Data Carrier: GS1 Data Matrix (Crypto Code)
Details: Pharmaceutical monitoring requirements in Russia cover domestically produced and imported products. The first draft law was officially published in December 2017. Traceability practices were introduced step-by-step, for example, while registration to the system started in 2019 for high-cost pharamceuticals, registrations to the traceability system became mandatory for all pharamceuticals as of July 1, 2020. It is a pharmaceutical tracking center in the Russian Federation and a system called Chestny Znak is used for traceability. Data for serialization in Russia takes place through the application of a 2D code called cryptocode. The purpose of the crypto code application with the GTIN and serial number on the product packaging of Russia is to be able to host more data more securely. Along with serialization, which is the singularization process of each product in Russia, the application of aggregation, which establishes the hierarchy of these products with the transport unit, is also mandatory.
- GTIN
- Serial Number
- Crypto Key (AI 91)
- Crypto Signature (AI92)
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