Track and Trace compliance for pharmaceutical exports requires GS1 barcoding and central portal data upload, subject to limited exemptions. Manufacturers and exporters must apply GS1-standard barcoding on secondary and tertiary packaging and upload prescribed packaging data to the central portal before release. Primary pack barcoding is temporarily exempted, but human-readable details are required. Manufacturers must maintain a Parent-Child Relationship across packaging levels and upload that data, subject to phased exemptions for all manufacturers and extended relief for SSI manufacturers; consignments manufactured before exemption cut-offs are exempt from upload. Liability for data accuracy and timely upload lies with the manufacturer or exporter, and importer-mandated requirements may permit alternate compliance with prior approval.
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Provisions expressly mentioned in the judgment/order text.
Track and Trace compliance for pharmaceutical exports requires GS1 barcoding and central portal data upload, subject to limited exemptions.
Manufacturers and exporters must apply GS1-standard barcoding on secondary and tertiary packaging and upload prescribed packaging data to the central portal before release. Primary pack barcoding is temporarily exempted, but human-readable details are required. Manufacturers must maintain a Parent-Child Relationship across packaging levels and upload that data, subject to phased exemptions for all manufacturers and extended relief for SSI manufacturers; consignments manufactured before exemption cut-offs are exempt from upload. Liability for data accuracy and timely upload lies with the manufacturer or exporter, and importer-mandated requirements may permit alternate compliance with prior approval.
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