AIDC Healthcare Implementation Guide - GS1

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AIDC Healthcare Implementation GuideMINIMUM Level of AIDC Marking(Retail)Pharmaceuticals Distributed and/or SoldPrimarily Via Retail ChannelsFigure 3-2 Pharmaceutical Marking GridMINIMUM Level of AIDC Marking(Non-Retail)Pharmaceuticals Distributed and/or SoldPrimarily Via Non-Retail Channels#DPM-1 #DPM-2 #DPM-3HIGHEST Level of AIDC MarkingPharmaceuticals Distributed and/or SoldVia Retail and/or Non-Retail ChannelsDirect PartMarkENCODED DATAManufacturerDistributor / RepackerNo AIDC DataDATA CARRIERManufacturerDistributor / RepackerNo AIDC CarrierENCODED DATAManufacturerDistributor / RepackerNo AIDC DataDATA CARRIERManufacturerDistributor / RepackerNo AIDC CarrierENCODED DATAManufacturerDistributor / RepackerNo AIDC DataDATA CARRIERManufacturerDistributor / RepackerNo AIDC CarrierHospitalNo AIDC DataHospitalNo AIDC CarrierHospitalNo AIDC DataHospitalNo AIDC CarrierHospitalNo AIDC DataHospitalNo AIDC CarrierPrimaryPackage#PP-1 #PP-2 #PP-3ENCODED DATAManufacturerDistributor / RepackerNo AIDC DataHospitalNo AIDC DataDATA CARRIERManufacturerDistributor / RepackerNo AIDC CarrierHospitalNo AIDC CarrierENCODED DATAManufacturerDistributor / RepackerGTIN-8; -12; -13; or -14,or EPC SGTIN (if RFID)HospitalNo AIDC DataDATA CARRIERManufacturerDistributor / RepackerGS1-128, DataBar, DataMatrix, or RFIDHospitalNo AIDC Carrier#SP-1 #SP-2 #SP-3ENCODED DATAManufacturerDistributor / RepackerGTIN-8; -12; -13; or -14,or EPC SGTIN (if RFID)HospitalGTIN-8; -12; -13; or -14,+ Serial No. + AI(7003)for short-expiry itemDATA CARRIERManufacturerDistributor / RepackerGS1-128, DataBar, DataMatrix, or RFIDHospitalGS1-128, DataBar, DataMatrix, or RFIDSecondaryPackagingENCODED DATAManufacturerDistributor / RepackerGTIN-8; -12; -13HospitalNo AIDC DataDATA CARRIERManufacturerDistributor / RepackerUPC-E, UPC-A, EAN-8,EAN-13, or DataBarHospitalNo AIDC CarrierENCODED DATAManufacturerDistributor / RepackerGTIN-8; -12; -13; or -14,+ Lot + Expiry, orEPC SGTIN (if RFID)HospitalNo AIDC DataDATA CARRIERManufacturerDistributor / RepackerGS1-128, DataBar, DataMatrix, or RFIDHospitalNo AIDC Carrier#CS-1 #CS-2 #CS-3ENCODED DATADATA CARRIERManufacturerManufacturerDistributor / Repacker Distributor / Repacker1st Mark: GTIN-8, GTIN-12, or 1st Mark: UPC-E, UPC-A, EAN-GTIN-138, EAN-13, or DataBar2nd Mark:2nd Mark: GS1-128, DataBar,GTIN-8; -12; -13; or -14, Data Matrix, or RFID+ Lot + Expiry + Serial No,+ Potency,or EPC SGTIN (if RFID)HospitalGTIN-8; -12; -13; or -14,+ Serial No. + AI(7003)for short-expiry itemHospitalGS1-128, DataBar,Data Matrix, or RFIDCase /ShipperENCODED DATAManufacturerDistributor / RepackerIf Trade Item:GTIN-8; -12; -13; or -14,+ Lot + Expiry, orEPC SGTIN (if RFID)If Logistics Unit:AI(00) SSCC orEPC SSCC (if RFID)DATA CARRIERManufacturerDistributor / RepackerGS1-128, Data Matrix, or RFIDENCODED DATAManufacturerDistributor / RepackerIf Trade Item:GTIN-8; -12; -13; or -14,+ Lot + Expiry, orEPC SGTIN (if RFID)If Logistics Unit:AI(00) SSCC orEPC SSCC (if RFID)DATA CARRIERManufacturerDistributor / RepackerGS1-128, Data Matrix, or RFIDENCODED DATAManufacturerDistributor / RepackerIf Trade Item:GTIN-8; -12; -13; or -14,+ Lot + Expiry + Serial No,+ Potency, or EPC SGTIN (ifRFID)If Logistics Unit:AI(00) SSCC orEPC SSCC (if RFID)DATA CARRIERManufacturerDistributor / RepackerGS1-128, Data Matrix, or RFIDHospitalNo AIDC DataHospitalNo AIDC CarrierHospitalNo AIDC DataHospitalNo AIDC Carrier#P-1 #P-2 #P-3HospitalGTIN-8; -12; -13; or -14,+ Serial No. + AI(7003)for short-expiry itemHospitalGS1-128, Data Matrix, or RFIDPalletENCODED DATAManufacturerDistributor / RepackerIf Trade Item:GTIN-8; -12; -13; or -14,+ Lot + Expiry, orEPC SGTIN (if RFID)DATA CARRIERManufacturerDistributor / RepackerGS1-128, or RFIDENCODED DATAManufacturerDistributor / RepackerIf Trade Item:GTIN-8; -12; -13; or -14,+ Lot + Expiry, or EPC SGTIN(if RFID)DATA CARRIERManufacturerDistributor / RepackerGS1-128 or RFIDENCODED DATAManufacturerDistributor / RepackerIf Trade Item:GTIN-8; -12; -13; or -14,+ Lot + Expiry + Serial No,or EPC SGTIN (if RFID)DATA CARRIERManufacturerDistributor / RepackerGS1-128 or RFIDIf Logistics Unit:AI(00) SSCC, or EPC SSCC(if RFID)If Logistics Unit:AI(00) SSCC, or EPC SSCC(if RFID)If Logistics Unit:AI(00) SSCC, or EPC SSCC(if RFID)HospitalNo AIDC DataHospitalNo AIDC CarrierHospitalNo AIDC DataHospitalNo AIDC CarrierHospitalNo AIDC DataHospitalNo AIDC CarrierIssue 1.1, Approved, Dec-2010 All contents copyright © GS1 Page 12 of 33
AIDC Healthcare Implementation Guide3.2. Marking for Medical DevicesWhen the AIDC marking of Medical Devices is required, the following flow diagram will assist thereader in visualizing the navigation of Healthcare Marking for Medical Devices. This should bereviewed in conjunction with the GS1 General Specifications. Not all Medical Device trade items mayrequire AIDC marking, as defined by regulations and/or manufacturers’ processes.StartFigure 3-3 Medical Devices MarkingIs Trade Itempackaged?NoDirect Part Marking(Marked with “DI” asminimum)YesIs Trade Itema “Reusable”Product?NoYesDirect Part Marking(Marked with “DI” asminimum)Is the LowestPackaging Levelto be marked?NoMark all HigherPackaging Levels(Marked with “DI” + “PI”)YesMark lowest PackagingLevel (Marked with “DI”as Minimum)EndNote: In all instances, the reader should refer to the appropriate Trade Item ApplicationSpecification section of the GS1 General Specifications should be referred to for detailedinformation and guidance on AIDC Marking.For the purpose of this document and its related application:■■■“Device/Drug Identifier”, “DI” as indicated in the Decision Tree, is the identifier for the tradeitem and is at a minimum, the Global Trade Item Number (GTIN).“Production Identifier(s)”, “PI” as indicated in the Decision Tree, are Expiry Date, Batch / LotNumbers and/or Serial Numbers used for product traceability. In applying “ProductionIdentifiers” it is the brand owner / manufacturer‘s decision whether a product is lot or serialnumber controlled.Instances noted above of “DI” only indicate “MINMUM Level of AIDC Marking” and instancesnoted above of “DI” + “PI” indicate ENHANCED and HIGHEST Levels of AIDC Marking”. Asthe “MINIMUM Level of AIDC Marking” may in some cases include no AIDC marking as anIssue 1.1, Approved, Dec-2010 All contents copyright © GS1 Page 13 of 33
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AIDC Healthcare Implementation Guide - GS1

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