Global Compliance

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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, Brazil, South Korea, Saudi Arabia and Russia. 

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. 

Brazil (ANVISA)

Serialization Status: Required
Code Format - 2D Data Matrix
GTIN - AI (01)
ANVISA Registry Number
Expiration Date - AI (17)
Batch/Lot Number - AI (10)
Serial Number - AI (21)

India (iVEDA)

Serialization Status: Required
Code Format - 2D Data Matrix
GTIN - AI (01)
Expiration Date - AI (17)
Batch/Lot Number - AI (10)
Serial Number - AI (21)

Russia (MDLP)

Serialization Status: Required
Code Format - 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 - 2D Data Matrix
GTIN - AI (01)
Expiration Date - AI (17)
Batch Number - AI (10)
Serial Number - AI (21)
National Health Number - Where Necessary

US (DSCSA)

Serialization Status: Required
Code Format - 2D Data Matrix
GTIN - AI (01)
Expiration Date - AI (17)
Batch/Lot Number - AI (10)
Serial Number - AI (21)


Nigeria (NAFDAC MAS)

Serialization Status: Required
Code Format - Scratch Off Labels

Scratch off Labels with alphanumeric codes printed on to them.



Jordan (FDA)

Serialization Status: Required
Code Format - 2D Data Matrix
GTIN - AI (01)
Expiration Date - AI (17)
Batch/Lot Number - AI (10)
Serial Number - AI (21)




Bahrain (NHRA)

Serialization Status: Required
Code Format - 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: 2D Data Matrix & GS1-128 Barcode
GTIN - AI(01) - 14 digits
Expiration Date - AI(17) - YYMMDD Format
Batch/Lot Number - AI(10) - Up to 20 alphanumeric characters in length
Serial Number - AI (21) - Up to 20 alphanumeric characters in length

Discover our world-leading serialization software

Secure your products with our scalable software solutions that are equal parts cost-effective and robust. These include our cutting-edge software, psID Manage Suite and psID TruTrak, a full-service suite of hardware and software solutions.

Looking for serialization hardware?

Whether you need efficient machines that can integrate with your existing software or a full suite of software and hardware solutions, we can customise it for you.

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