Track and trace for pharmaceutical exports requires GS1 barcode serialization and submission of Certificates of Analysis for shipments. Exporters of drugs and pharmaceuticals must implement a track and trace system using GS1 barcode standards and submit a Certificate of Analysis at shipment. Primary packs require 2D GS1 Data Matrix barcodes encoding GTIN and a unique serial number; secondary packs require 1D or 2D barcodes encoding GTIN, batch number, expiry date and unique serial number (mono cartons treated as secondary); tertiary packs require 1D barcodes encoding GTIN, batch number, expiry date and unique serial number. Manufacturers must retain serialized export records for six months after product expiry, authentication features will be integrated later, and a Central Portal will be established.
Cases where this provision is explicitly mentioned in the judgment/order text; may not be exhaustive. To view the complete list of cases mentioning this section, Click here.
Provisions expressly mentioned in the judgment/order text.
Track and trace for pharmaceutical exports requires GS1 barcode serialization and submission of Certificates of Analysis for shipments.
Exporters of drugs and pharmaceuticals must implement a track and trace system using GS1 barcode standards and submit a Certificate of Analysis at shipment. Primary packs require 2D GS1 Data Matrix barcodes encoding GTIN and a unique serial number; secondary packs require 1D or 2D barcodes encoding GTIN, batch number, expiry date and unique serial number (mono cartons treated as secondary); tertiary packs require 1D barcodes encoding GTIN, batch number, expiry date and unique serial number. Manufacturers must retain serialized export records for six months after product expiry, authentication features will be integrated later, and a Central Portal will be established.
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