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Global Compliance

Pharmaceutical and food safety regulations exist globally to combat counterfeit drugs and maintain quality and safety standards. Our serialization and traceability solutions are designed to keep up with trade regulations worldwide. This enables our clients to seamlessly conform with various global mandates of countries including the United States, European Union, India (exports), India (domestic QR coding),Russia, Turkey, and Saudi Arabia.

Regulations can be complex but the compliance process doesn’t have to be

We pride ourselves on our on-demand support and after-service. This means that you can rely on our experts for a detailed walk-through to better understand the serialization mandates. Browse through our country-specific guides below for an overview.

India Exports (iVEDA)
  • Serialization Status: Required
  • Code Format - GS1 2D Data Matrix
  • GTIN - AI (01)
  • Expiration Date - AI (17)
  • Batch/Lot Number - AI (10)
  • Serial Number - AI (21)
India (Top 300)
  • Serialization Status: Required on Top 300 brands
  • Code Format - QR Code or Barcode , Unique Product identification code, Proper and generic name of the drug, Brand name, Name and address of the manufacturer, Batch number, Date of manufacturing, Date of expiry, Manufacturing licence number
Russia (MDLP)
  • Serialization Status: Required
  • Code Format - GS1 2D Data Matrix
  • GTIN - AI (01)
  • Unique Serial Number - AI (21)
  • Key (4 Digit Code) - AI (91)
  • Signature - AI (92)
European Union (FMD)
  • Serialization Status: Required
  • Code Format - GS1 2D Data Matrix
  • GTIN - AI (01)
  • Expiration Date - AI (17)
  • Batch Number - AI (10)
  • Serial Number - AI (21)
  • National Health Number - Where Necessary
United States (DSCSA)
  • Serialization Status: Required
  • Code Format - GS1 2D Data Matrix
  • GTIN - AI (01)
  • Unique Serial Number - AI (21)
  • Key (4 Digit Code) - AI (91)
  • Signature - AI (92)
Nigeria (NAFDAC MAS)
  • Serialization Status: Required
  • Code Format - Scratch Off Labels with alphanumeric codes printed on to them.
Uzbekistan
  • Serialization Status: Required
  • Code Format - GS1 2D Data Matrix
  • GTIN - AI (01)
  • Unique Serial Number - AI (21)
  • Key (4 Digit Code) - AI (91)
  • Signature - AI (92)
Bahrain (NHRA)
  • Serialization Status: Required
  • Code Format - GS1 2D Data Matrix
  • GTIN - AI (01)
  • Expiration Date - AI (17)
  • Batch/Lot Number - AI (10)
  • Serial Number - AI (21)
Saudi Arabia (SFDA)
  • Serialization: Required
  • Code Format: GS1 2D Data Matrix & GS1-128 Barcode
  • GTIN - AI(01)
  • Expiration Date - AI(17)
  • Batch/Lot Number - AI(10)
  • Serial Number - AI (21)
Discover our world-leading serialization software

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