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About the Serialization compliance checker
Compare pack serialisation rules for pharmaceutical exports across major markets, including India, the US and the EU.
How to use it
- Select the countries you sell or export to.
- Review the identifiers, data carriers and reporting each market asks for.
- Confirm the current rule with the regulator before you change artwork or lines.
Questions and answers
Is this legal advice?
No. Rules and deadlines change. Use this as a starting map and confirm each requirement with the regulator or your regulatory team.
How does FirstScanIt fit with serialisation?
Serialisation gives each pack a unique number. FirstScanIt adds a maker’s signature to that code so buyers can check it is genuine, and works with GS1 Digital Link and EPCIS.
Does India require QR codes on medicines?
Schedule H2 requires QR codes on the labels of specified top-selling medicine brands. Check CDSCO notifications for the current list and fields.
Official sources
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GS1 Digital Link builderBuild a GS1 element string and a GS1 Digital Link address from GTIN, batch, expiry and serial for pack QR codes.Packaging security scorecardScore how well your packaging resists tampering and copying, and see which protections to add first.GMP audit checklistGenerate a GMP self-audit checklist for Schedule M, WHO GMP, US FDA cGMP or EU GMP and track your progress.
Want buyers to check your packs themselves? FirstScanIt puts a maker-signed QR code on every pack that anyone can check with a phone camera. See how manufacturers start.