Announcement of Intention to Implement Global Standards for Product Identification, Labeling, and Data Exchange MAY 15, 2017
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1 USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM PROCUREMENT AND SUPPLY MANAGEMENT Announcement of Intention to Implement Global Standards for Product Identification, Labeling, and Data Exchange MAY 15, 2017
2 PREFACE The USAID Global Health Supply Chain Program-Procurement and Supply Management (GHSC-PSM) project will implement a product identification, labeling, and data exchange requirement for commodities procured under this mechanism. The requirement leverages existing global standards and seeks to harmonize with the global health marketplace to: Enable end-to-end data visibility Identify and implement supply chain efficiencies Ensure supply chain security Increase patient safety A formal requirement will be included in all bid solicitations and contracts by the end of calendar year GHSC-PSM expects suppliers to implement this requirement in accordance with the timeline with no subsequent impact on ceiling prices in contracts through the duration of the project. A technical guideline detailing label standards, placement, and appropriate references to the GS1 General Specification will be released before inclusion in contracts to inform supplier implementation. Suppliers are encouraged to reach out to their local GS1 Member Organization if they require support for implementation. Product and location master data exchange will occur through the Global Data Synchronization Network. Transactional data exchange, including serial numbers referenced here, will occur through the GHSC-PSM Automated Requisition Tracking Management Information System Logistics Management Information System. Additional information on the electronic data exchange requirement, protocol, and timeline will be included in the forthcoming technical guideline. For questions or comments on the information included here, please globalstandards@ghscpsm.org.
3 ACRONYMS AI... application identifier ASAP... as soon as possible HRI... human readable interpretation GHSC-PSM... Global Health Supply Chain-Procurement and Supply Management GTIN... global trade item number NLT... no later than SSCC... serial shipping container code TBD... to be determined
4 1 REQUIREMENTS FOR PHARMACEUTICALS 1.1 TERTIARY PACKAGING LOGISTICS ITEM (PALLET OR CASE) The minimum GS1 Identification Key and application identifier (AI) to be included in a GS1 128 Linear Barcode, with the applicable human readable interpretation (HRI) printed adjacent: (00) Serial shipping container code (SSCC) As soon as possible (ASAP) but no later than (NLT) June 30, TERTIARY PACKAGING TRADE ITEM (PALLET OR CASE) The minimum GS1 Identification Key and AI to be included in a GS1 128 Linear Barcode or GS1 Datamatrix, with the applicable HRI printed adjacent: (01) Global trade item number (GTIN) ASAP but NLT Dec 30, 2018 (10) BATCH/LOT ASAP but NLT Dec 30, 2018 (17) EXPIRATION DATE ASAP but NLT Dec 30, 2018 (21) SERIAL NUMBER ASAP but NLT Jun 30, SECONDARY PACKAGING TRADE ITEM (MULTI-PACK AND/OR SINGLE-PACK CARTON) The minimum GS1 Identification Key and AI to be included in a GS1 Datamatrix, with the applicable HRI printed adjacent: (01) GTIN ASAP but NLT Jun 30, 2020 (10) BATCH/LOT ASAP but NLT Jun 30, 2020 (17) EXPIRATION DATE ASAP but NLT Jun 30, 2020 (21) SERIAL NUMBER ASAP but NLT Jun 30, 2022
5 2 REQUIREMENTS FOR MEDICAL DEVICES, STERILE KITS, DIAGNOSTIC TESTS, AND REAGENTS 2.1 TERTIARY PACKAGING LOGISTICS ITEM (PALLET OR CASE) The minimum GS1 Identification Key and AI to be included in a GS1 128 Linear Barcode, with the applicable HRI printed adjacent: (00) SSCC ASAP but NLT Jun 30, TERTIARY PACKAGING TRADE ITEM (PALLET OR CASE) The minimum GS1 Identification Key and AI to be included in a GS1 128 Linear Barcode or GS1 Datamatrix, with the applicable HRI printed adjacent: (01) GTIN ASAP but NLT Dec 30, 2018 (10) BATCH/LOT ASAP but NLT Dec 30, 2018 (17) EXPIRATION DATE ASAP but NLT Dec 30, 2018 (21) SERIAL NUMBER Applicability to be determined (TBD) 2.3 SECONDARY PACKAGING TRADE ITEM (MULTI-PACK AND/OR SINGLE-PACK CARTON) The minimum GS1 Identification Key and AI to be included in a GS1 Datamatrix, with the applicable HRI printed adjacent: (01) GTIN ASAP but NLT Jun 30, 2020 (10) BATCH/LOT ASAP but NLT Jun 30, 2020 (17) EXPIRATION DATE ASAP but NLT Jun 30, 2020 (21) SERIAL NUMBER Applicability TBD
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