Russia – Enacted

v. 2.2 – 01/22/18

Serialization Model Track and Trace
Governing Body Ministry of Healthcare of the Russian Federation
Compliance Date
  • January 1, 2020: Track and Trace requirements in effect
  • Medicines 7 therapy areas, EDL medicines & High Priority Drugs may be subject to an earlier deadline.
Randomization Requirements 13-digit, randomized, alphanumeric Serial Number (where alphabet characters – Latin alphabet; randomization probability of guessing SN less than 1:10,000)
Data Repository FSIS MDC (Federal State Information System for Monitoring of Drugs Circulation)
Aggregation Requirements Saleable (secondary or consumer) pack to Logistics (factory and/or transport) packaging
Saleable Unit Data Carrier
  • GS1 DataMatrix encoding GTIN, Serial Number,
    Lot/Batch, Expiry, FEANC (Foreign Economic Activity Commodity Nomenclature), using AI (01), (21), (10),
    (17), and (240)
  • NOTE: Expiry date encoded in “YYMMDD” format (if day not set, then DD must be “01” representing first day of month)
Saleable Unit HRI IC (01): GTIN; SN (21): Serial Number; BN (10):
Batch Number; ED (17): Expiration date in DDMMYY format
Intermediate Package Data Carrier GS1-128 or GS1 DataMatrix encoding GTIN and Serial Number,using AI (01) and (21)
Intermediate Package HRI Not Specified
Logistics Unit Data Carrier
  • Manufacturers and Wholesalers: GS1-128 encoding SSCC using AI (00)
  • Wholesalers that don’t have a GS1 company prefix: Code 128 encoding “SSCC-like” number, 18-digits (extension digit + 9-digit organization identifier in Markingn IS [assigned upon request]
    + 7-digit transport serial identifier + check digit)–precede with AI (999)
Logistics Unit HRI Not specified
Additional Notes

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