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Article(id=1248600573063352682, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1248600564427280576, articleNumber=1001-2494(2024)05-0463-06, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1682092800000, receivedDateStr=2023-04-22, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1775619174494, onlineDateStr=2026-04-08, pubDate=1709827200000, pubDateStr=2024-03-08, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1775619174494, onlineIssueDateStr=2026-04-08, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1775619174494, creator=13701087609, updateTime=1775619174494, updator=13701087609, issue=Issue{id=1248600564427280576, tenantId=1146029695717560320, journalId=1190317699101192196, year='2024', volume='59', issue='5', pageStart='377', pageEnd='468', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1775619172436, creator=13701087609, updateTime=1775619904979, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1248603637019202091, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1248600564427280576, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1248603637023396396, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1248600564427280576, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=463, endPage=468, ext={EN=ArticleExt(id=1248600573386314108, articleId=1248600573063352682, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=Research on the Traceability and Identification System for Exported Vaccine Products, columnId=null, journalTitle=Chinese Pharmaceutical Journal, columnName=null, runingTitle=null, highlight=null, articleAbstract=

OBJECTIVE To establish a design scheme for the traceability and labeling system of exported vaccine products, in order to meet the technical requirements of the World Health Organization(WHO) and some Western countries for vaccine traceability and labeling. METHODS By studying the laws, regulations, standards, and policy documents on vaccine traceability labeling at home and abroad, the similarities and differences between domestic and foreign traceability labeling systems were analyzed and compared. RESULTS A technical solution for traceability coding, labeling, carrier, printing, and other aspects of exported vaccine products was established based on the GS1 standard system that meets domestic and international requirements. CONCLUSION It is necessary to strengthen the formulation of policies and standards for the traceability and labeling system for exported vaccine products in China, and implement and promote them.

, correspAuthors=Qiang LIN, Yue LONG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=Ruizhi LIU, Qiang LIN, Yue LONG, Xuejing WANG, Baogang JIANG, Yixuan LIU), CN=ArticleExt(id=1248600577630949957, articleId=1248600573063352682, tenantId=1146029695717560320, journalId=1190317699101192196, language=CN, title=出口疫苗产品追溯标识系统研究, columnId=1190352405612040510, journalTitle=中国药学杂志, columnName=论著, runingTitle=null, highlight=null, articleAbstract=

目的 建立出口疫苗产品追溯标识系统设计方案,满足世界卫生组织(WHO)和一些西方国家对于疫苗追溯标识的技术要求。 方法 通过对国内外疫苗追溯标识法律法规、标准、政策文件的研究,分析比较国内外追溯标识制度的异同。结果 建立了满足国内外要求的基于国际物品编码组织(GS1)标准体系的出口疫苗产品追溯编码、标识、载体、印制等技术方案。结论 我国出口疫苗产品追溯标识制度需要加强政策、标准的制定,并加以实施和推广。

, correspAuthors=林强, 龙跃, authorNote=null, correspAuthorsNote=
*林强,男,博士,高级工程师 研究方向:自动识别技术与追溯系统研究 Tel:(010)84295402;
龙跃,男,高级工程师 研究方向:物联网信息通信实验室认可技术研究 Tel:(010)67105431
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刘睿智,男,高级工程师 研究方向:条码技术与应用研究

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刘睿智,男,高级工程师 研究方向:条码技术与应用研究

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刘睿智,男,高级工程师 研究方向:条码技术与应用研究

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Med Anim Control(医学动物防治), 2020, 36 (9): 867-869., articleTitle=Research on the construction of vaccine circulation full traceability information system in Zhangjiagang City, refAbstract=null), Reference(id=1248642350965220171, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1248600573063352682, doi=null, pmid=null, pmcid=null, year=2020, volume=null, issue=3, pageStart=40, pageEnd=43, url=null, language=null, rfNumber=[5], rfOrder=4, authorNames=HU Q, CHENG X Y, journalName=条码与信息系统, refType=null, unstructuredReference=HU Q, CHENG X Y. Using barcode detectors to improve barcode quality[J]. Barcode Inf Syst(条码与信息系统), 2020(3): 40-43., articleTitle=Using barcode detectors to improve barcode quality, refAbstract=null), Reference(id=1248642351049106256, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1248600573063352682, doi=null, pmid=null, pmcid=null, year=2020, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[6], rfOrder=5, authorNames=null, journalName=XIAO Y. Design and Implementation of an Automatic Vaccine Traceability System, refType=null, unstructuredReference=XIAO Y. Design and Implementation of an Automatic Vaccine Traceability System[D]. Chengdu: Chengdu University of Technology, 2020., articleTitle=null, refAbstract=null), Reference(id=1248642351137186643, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1248600573063352682, doi=null, pmid=null, pmcid=null, year=2019, volume=null, issue=6, pageStart=43, pageEnd=46, url=null, language=null, rfNumber=[7], rfOrder=6, authorNames=ZHENG Z C, journalName=条码与信息系统, refType=null, unstructuredReference=ZHENG Z C. The impact of packaging background color on the quality inspection of product barcode printing and corresponding measures[J]. Barcode Inf Syst(条码与信息系统), 2019(6): 43-46., articleTitle=The impact of packaging background color on the quality inspection of product barcode printing and corresponding measures, refAbstract=null), Reference(id=1248642351216878422, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1248600573063352682, doi=null, pmid=null, pmcid=null, year=2019, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[8], rfOrder=7, authorNames=LIU X P, journalName=Research on Quality Detection Technology of Curved Product Barcode Based on Binocular Vision, refType=null, unstructuredReference=LIU X P. Research on Quality Detection Technology of Curved Product Barcode Based on Binocular Vision[D]. Xi'an: Xi'an University of Technology, 2019., articleTitle=null, refAbstract=null), Reference(id=1248642351313347418, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1248600573063352682, doi=null, pmid=null, pmcid=null, year=2016, volume=null, issue=2, pageStart=22, pageEnd=null, url=null, language=null, rfNumber=[9], rfOrder=8, authorNames=ZHANG Y, journalName=中国自动识别技术, refType=null, unstructuredReference=ZHANG Y. Implementing vaccine traceability using GS1 data matrix code[J]. 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A-疫苗瓶签的RSS缩小空间码;B-疫苗物流单元包装追溯码。

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A-销售单元的赋码要求;B-物流包装的赋码要求。

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结构类型 指示符 厂商识别代码(7~10位) 商品项目代码(2~5位) 校验位(1位)
GTIN-13 0 N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13
GTIN-14 N0 N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13
), ArticleFig(id=1248642349606265616, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1248600573063352682, language=CN, label=表1, caption=

出口疫苗产品标识代码结构

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结构类型 指示符 厂商识别代码(7~10位) 商品项目代码(2~5位) 校验位(1位)
GTIN-13 0 N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13
GTIN-14 N0 N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13
), ArticleFig(id=1248642349706928917, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1248600573063352682, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
应用标识符(AI) 含义
(01) 全球贸易项目代码
(17) 有效期
(10) 生产批号
(21) 序列号
), ArticleFig(id=1248642349782426395, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1248600573063352682, language=CN, label=表2, caption=

出口疫苗产品追溯码代码应用标识符及含义

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应用标识符(AI) 含义
(01) 全球贸易项目代码
(17) 有效期
(10) 生产批号
(21) 序列号
), ArticleFig(id=1248642349853729565, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1248600573063352682, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
包装
层级		 疫苗追溯码代码 通过应用标识符
连接形成的字符串
产品标识代码 生产标识代码
指示符 厂商识别代码 商品项目代码 校验位 有效期 生产批号 序列号
初级包装 1 6901234 56789 9 250630 1234AB 001 (01)16901234567899(17)250630(10)1234AB(21)001
二级包装 0 6901234 56789 2 250630 1234AB 001 (01)06901234567892(17)250630(10)1234AB(21)001
三级包装 2 6901234 56789 6 250630 1234AB 001 (01)26901234567896(17)250630(10)1234AB(21)001
), ArticleFig(id=1248642349946004259, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1248600573063352682, language=CN, label=表3, caption=

出口疫苗产品各级包装疫苗追溯码代码示例

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包装
层级		 疫苗追溯码代码 通过应用标识符
连接形成的字符串
产品标识代码 生产标识代码
指示符 厂商识别代码 商品项目代码 校验位 有效期 生产批号 序列号
初级包装 1 6901234 56789 9 250630 1234AB 001 (01)16901234567899(17)250630(10)1234AB(21)001
二级包装 0 6901234 56789 2 250630 1234AB 001 (01)06901234567892(17)250630(10)1234AB(21)001
三级包装 2 6901234 56789 6 250630 1234AB 001 (01)26901234567896(17)250630(10)1234AB(21)001
), ArticleFig(id=1248642350013113128, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1248600573063352682, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
扩展位 厂商识别代码 系列号 校验码
N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13 N14 N15 N16 N11 N17 N18
), ArticleFig(id=1248642350134747944, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1248600573063352682, language=CN, label=表4, caption=

出口疫苗产品物流单元追溯码代码结构

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扩展位 厂商识别代码 系列号 校验码
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出口疫苗产品追溯标识系统研究
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刘睿智 1 , 林强 1, * , 龙跃 2, * , 王雪晶 3 , 姜宝刚 4 , 刘一漩 1
中国药学杂志 | 论著 2024,59(5): 463-468
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中国药学杂志 | 论著 2024, 59(5): 463-468
出口疫苗产品追溯标识系统研究
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刘睿智1, 林强1, *, 龙跃2, *, 王雪晶3, 姜宝刚4, 刘一漩1
作者信息
  • 1 中国物品编码中心, 北京 100011
  • 2 中国合格评定国家认可中心, 北京 100062
  • 3 北京嘉华汇诚科技股份有限公司, 北京 100085
  • 4 中国生物技术股份有限公司, 北京 100024

    • 刘睿智,男,高级工程师 研究方向:条码技术与应用研究

通讯作者:

*林强,男,博士,高级工程师 研究方向:自动识别技术与追溯系统研究 Tel:(010)84295402;
龙跃,男,高级工程师 研究方向:物联网信息通信实验室认可技术研究 Tel:(010)67105431
Research on the Traceability and Identification System for Exported Vaccine Products
Ruizhi LIU1, Qiang LIN1, *, Yue LONG2, *, Xuejing WANG3, Baogang JIANG4, Yixuan LIU1
Affiliations
  • 1 GS1 China, Beijing 100011, China
  • 2 China National Accreditation Service for Conformity Assessment, Beijing 100062, China
  • 3 Beijing Jiahua Huicheng Technology Co., Ltd., Beijing 100085, China
  • 4 China National Biotec Group Co., Ltd., Beijing 100024, China
出版时间: 2024-03-08
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摘要
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目的 建立出口疫苗产品追溯标识系统设计方案,满足世界卫生组织(WHO)和一些西方国家对于疫苗追溯标识的技术要求。 方法 通过对国内外疫苗追溯标识法律法规、标准、政策文件的研究,分析比较国内外追溯标识制度的异同。结果 建立了满足国内外要求的基于国际物品编码组织(GS1)标准体系的出口疫苗产品追溯编码、标识、载体、印制等技术方案。结论 我国出口疫苗产品追溯标识制度需要加强政策、标准的制定,并加以实施和推广。

国际物品编码组织  /  疫苗  /  追溯标识  /  追溯系统

OBJECTIVE To establish a design scheme for the traceability and labeling system of exported vaccine products, in order to meet the technical requirements of the World Health Organization(WHO) and some Western countries for vaccine traceability and labeling. METHODS By studying the laws, regulations, standards, and policy documents on vaccine traceability labeling at home and abroad, the similarities and differences between domestic and foreign traceability labeling systems were analyzed and compared. RESULTS A technical solution for traceability coding, labeling, carrier, printing, and other aspects of exported vaccine products was established based on the GS1 standard system that meets domestic and international requirements. CONCLUSION It is necessary to strengthen the formulation of policies and standards for the traceability and labeling system for exported vaccine products in China, and implement and promote them.

GS1  /  vaccine  /  traceability labeling  /  traceability system
刘睿智, 林强, 龙跃, 王雪晶, 姜宝刚, 刘一漩. 出口疫苗产品追溯标识系统研究. 中国药学杂志, 2024 , 59 (5) : 463 -468 .
Ruizhi LIU, Qiang LIN, Yue LONG, Xuejing WANG, Baogang JIANG, Yixuan LIU. Research on the Traceability and Identification System for Exported Vaccine Products[J]. Chinese Pharmaceutical Journal, 2024 , 59 (5) : 463 -468 .
正文
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2019年底,新型冠状病毒席卷全球,接种疫苗是预防新型冠状病毒感染的重要手段。2021年5月7日,世界卫生组织(World Health Organization,WHO)宣布,将中国国药集团中国生物北京生物制品研究所研发的新型冠状病毒(COVID-19)感染疫苗列入“紧急使用清单”(EUL)。EUL是为新冠肺炎疫苗实施计划(COVAX)设施提供疫苗的先决条件,该清单还允许各国加快各自的监管批准,以进口和管理新冠疫苗。为防止疫苗仿制、欺诈和转移,世界卫生组织要求各国建立行之有效的跟踪和追溯系统,使用国际物品编码组织(GS1)标准来实现对COVID-19疫苗和治疗剂的跟踪与追溯。
1 国内疫苗追溯标识系统分析
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1.1 追溯码
药品追溯码是建立药品及其追溯数据的钥匙,是实现“一物一码,物码同追”药品追溯的必要前提和重要基础。药品追溯码是由一系列数字、字母和(或)符号组成的代码,包含药品标识代码段和生产标识代码段,用于唯一标识药品销售包装单元。药品标识为识别药品上市许可持有人/生产企业、药品名称、剂型、制剂规格和包装规格的唯一代码;生产标识由药品生产过程相关信息的代码组成,根据“一物一码,物码同追”的要求,应至少包含药品单品序列号,根据监管和实际应用需求,还可包含药品生产批次号、生产日期、有效期等。编码构成可以采用两种形式:其一是符合代码长度为20个字符,前7位为药品标识码(如药品电子监管码);其二是符合ISO/IEC 15459等相关国际标准的编码规则[1]。
国内各疫苗生产企业现主要采用码上放心追溯码。码上放心追溯码是20位数字加密编码,采用Code 128一维条码和数字字符形式组合体现,支持自动识别设备及人眼识读(只能读取编码信息)。码上放心追溯码分为一级追溯码(用于药品最小销售包装)、二级追溯码(用于药品中包装)、三级追溯码(用于药品外层包装),以此类推,分别用来标识最小销售包装药品、中间独立包装药品和外箱独立包装药品。但是,码上放心追溯码无法满足国际对疫苗产品追溯标识的技术要求,只能在国内使用。
1.2 数据载体
药品追溯码需要通过一定的载体(如一维码、二维码、电子标签等)赋码到药品产品上。目前药品使用的追溯码载体主要有一维条码、二维码、射频识别标签等。编码的载体是采集信息、进行数据交互的窗口,编码的清晰可读是编码载体的关键,应可被扫码设备和人眼识别。
1.3 追溯系统
我国疫苗追溯体系建设主要包括国家疫苗追溯协同服务平台、疫苗追溯监管系统、提供追溯服务的第三方追溯系统及企业自建追溯系统[2]。国家疫苗追溯系统架构见图1。系统间根据数据传输标准进行数据交互,实现疫苗产品的追溯[3]。主要相关系统包括:
疫苗追溯协同服务平台。疫苗追溯协同服务平台,在疫苗信息化追溯体系中发挥“桥梁”和“枢纽”作用,提供准确的疫苗生产企业和产品的基本信息、追溯码编码规则的备案和管理服务以及不同追溯系统的地址服务,辅助实现不同药品追溯系统的互联互通[4]。
疫苗追溯监管系统。在疫苗追溯协同服务平台基础上,监管部门组织建设疫苗追溯监管系统,根据监管需求采集数据,监控疫苗流向,实现数据汇总分析、风险预警等功能,为监管决策提供数据支持。
追溯系统。药品追溯系统是指基于药品追溯码、相关软硬件设备和通信网络,获取药品追溯过程中相关数据的集成,用于实现药品生产、流通和使用全程追溯信息的采集、存储和共享。
2 国外疫苗追溯标识系统分析
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2.1 美国
根据美国医药流通协会(HDA)发布《医药供应链编码指导》文件,对于在美国上市的处方药,包括人用疫苗等产品,均应当按照要求对产品的各级包装单元进行赋码。在《编码指导》文件中的第3章节,对于最小销售单元的产品标识(the product identifier)部分,对追溯码进行了详细的说明,见图2。
从上图的示例可以看出,HDA指导企业采用GTIN作为药品标识码,并且按照GS1编码标准使用相关AI项,包括:批号、失效日期和序列号。指导文件中还对供人识读字符的印刷,给出了建议,见图3。
HDA提出可以接受GS1推荐的全部使用AI加数据信息的HRI形式,也可以采用Non-HRI形式的印刷方法,即印刷英文缩写,如:GTIN、SN等字母,便于一般使用者阅读。在指导文件中,还展示了产品标签的展示形式,如使用EAN-13商品条码(GS1-128)用于药品结算环节,同时使用Datamatrix二维码(ECC-200)来满足追溯相关要求,见图4。
对于最小销售单元以上的包装层级,诸如:中盒、裹包和大箱等达到预设装量的二级包装,《指导文件》中建议使用包含追溯数据的大箱拐角标签。大箱标签包含上下两个GS1-128一维条码,其中一行为产品编码GTIN及箱序列号,另一行可包含批号、失效日期及装箱量,见图5。
与达到预设装量的二级包装不同的是,未达到满包装量的二级包装,应被定义为物流单元,而不是二级销售单元。因此,在零箱上,推荐使用系列货运包装箱代码(SSCC码),作为物流单元的标识,可选载体为GS1-128,见图6。
此外,在托盘标签上,也可使用SSCC码。在当前FDA的法规中,对托盘等物流单元的赋码并没有提出强制化的要求。美国绝大多数医药流通企业选择参照美国医药流通协会的建议,使用GS1-128一维条码为载体的SSCC码,对物流单元进行赋码和标识。
2.2 欧盟
为了响应《欧盟—反假药指令》(EU-FMD,EU2016/161)中防治假药的安全措施,欧盟成员国根据自身情况,发布了药品、疫苗标识相关的行政命令。部分成员国的监管部门,还对药品及疫苗的追溯码和标识提出了指导意见。
以德国为例,德国药品验证组织(NMVO官方组织)发布了《德国市场需要验证的药品编码规则》。文件中,要求企业使用GS1标准的DM二维码,作为药品及疫苗最小销售单元的赋码载体,并使用GTIN作为药品标识码。同样以德语为官方语言的奥地利,随后也发布了相似通知,并且给出了示范,见图7。
法国、丹麦、波兰、爱尔兰等国也相继发布了使用GS1标准DM二维码,对本国境内销售的药品及疫苗进行赋码的要求。英国在脱离欧盟后,仍然沿用脱欧前的药品验证系统,因此赋码的要求与上述国家保持一致。
2.3 日本
目前日本的药品和疫苗企业,仍在执行日本劳动厚生省于2006年发布的药品赋码要求的通知。由于使用习惯不同,日本的药品及疫苗,包装设计均比一般国家紧凑,因为日本企业多数选择使用更为紧凑的条码。目前市场上以(reduced space symbology,RSS)(缩小空间码)为主流,见图8。
在2021年,日本劳动厚生省曾发布了加强药品信息电子化记录的讨论稿,其中将QR码作为了一种选项,但截至2022年末,该讨论事项并没有更新发布进一步实施的进展。
2.4 联合国/WHO等组织
联合国在其官方的全球采购网站,发布了疫苗产品的标识赋予和信息交换要求,并且已经于2022年底成为联合国儿童基金会(UNICEF)采购疫苗产品的统一要求。文件明确了销售单元的一、二级包装使用包含GTIN的DM二维码,以及物流包装(托盘或大箱)上面使用GS1-128一维条码体现SSCC码,见图9。
此外, WHO还建设了疫苗信息追溯及验证数据平台,即“TRVST”系统,计划于2023年上线,支持收货方通过扫描上述条码来验证疫苗产品的身份信息。
3 出口疫苗产品包装层级与追溯标识
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出口疫苗产品追溯标识通常包括疫苗追溯码和物流单元追溯码。疫苗追溯码是用于唯一标识疫苗各级包装单元的代码,由一列数字、字母和(或)符号组成,包括产品标识代码和生产标识代码。物流单元追溯码是标识物流单元(非结算单元,为便于运输组成的包装单元)身份的唯一代码,由一列数字、字母和(或)符号组成。出口疫苗产品通常包含三个包装层级:初级包装、二级包装和三级包装。初级包装是与产品直接接触的第一级包装的项目;二级包装是包含一个或多个初级包装的包装;三级包装是第三级或更高级别的包装,分为贸易物流单元和非贸易物流单元。当疫苗产品初级包装是零售包装时,应具有疫苗追溯码;不是零售包装时,可以具有疫苗追溯码,也可以仅分配疫苗追溯码代码并记录在数据库中,不进行标识。二级包装应具有疫苗追溯码。当三级包装是贸易物流单元时,应具有疫苗追溯码;当是非贸易物流单元时,仅需具有物流单元追溯码。混箱(不同产品组成的物流单元)或零箱(相同产品因数量不足无法形成整箱)组成的非贸易物流单元,仅需具有物流单元追溯码。出口疫苗产品包装层级及追溯标识组成见图10。
4 出口疫苗产品追溯码编码方案
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4.1 疫苗追溯码编码方案
疫苗追溯码代码由产品标识代码和生产标识代码组成。产品标识代码是用于标识特定于某种与上市许可持有人、生产企业、通用名、剂型、制剂规格和包装规格对应的疫苗产品的唯一性代码。生产标识代码是用于识别疫苗产品在生产过程中相关数据的代码。
4.1.1 产品标识代码
产品标识代码采用GS1标准中全球贸易项目代码(GTIN)的代码结构,包括GTIN-13和GTIN-14。GTIN-13主要用于标识零售贸易项目,GTIN-14主要用于标识多个相同贸易项目的组合包装。代码结构见表1。
4.1.2 生产标识代码
出口疫苗产品生产标识代码一般由有效期、生产批号和序列号组成。 有效期由“年(2位)月(2位)日(2位)”共6位数字组成,如有效期2023年5月17日的代码表示为“230517”;生产批号和序列号分别由不超过20位的数字、字母和字符组成,由产品厂商识别代码所有者即疫苗生产企业自行编制。
4.1.3 应用标识符
应用标识符是标识数据含义与格式的字符。当代码用条码形式表示时,需通过应用标识符将产品标识代码和生产标识代码连接形成字符串。应用标识符及对应的数据编码共同完成特定信息的标识。疫苗追溯码中所需的应用标识符见表2。
4.1.4 示例
某疫苗产品生产企业的厂商识别代码是“6901234”,该企业生产的某款疫苗的商品贸易项目代码为“56789”,生产批号为“1234AB”,产品有效期为2025年6月30日。该产品初级包装为非零售包装,二级包装为零售包装,2个初级包装组成了二级包装,10个二级包装组成了一个三级包装,三级包装为储运包装。各级包装的序列号均为“001”。各级包装疫苗追溯码代码及通过应用标识符连接形成的字符串见表3。
4.2 物流单元追溯码编码方案
4.2.1 物流单元追溯码代码结构
物流单元追溯码是标识物流单元(非结算单元,为便于运输组成的包装单元)身份的唯一代码,由一列数字、字母和(或)符号组成。物流单元追溯码代码采用GS1标准中系列货运包装箱代码(SSCC)表示,由扩展位、厂商识别代码、系列号和校验位四部分组成,是18位的数字代码,具有全球唯一性。物流标识代码结构见表4。
4.2.2 应用标识符
系列货运包装箱代码与应用标识符(00)连接形成字符串。医疗行业通常单独使用应用标识符(00),无附加信息代码,不与其他应用标识符连用。
4.2.3 物流单元追溯码编码示例
某企业的厂商识别代码为“6901234”,该企业某个物流单元系列号为000000001,扩展位为0,则物流单元标识代码通过应用标识符连接形成的字符串为“(00)069012340000000018”。
5 条码表示
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条码是由一组规则排列的条、空组成的符号,可供机器识读,用以表示一定的信息,包括一维条码和二维条码。一维条码是仅在一个维度方向上表示信息的条码符号。二维码是在两个维度方向上都表示信息的条码符号。
GS1 DataMatrix码是一种矩阵式二维码,以Data Matrix ECC200为基础,在数据前部加入了特殊字符FNC1,使其区别于传统Data Matrix二维码,并能够充分支持GS1标准其最大特点就是密度高,尺寸小,储存信息量大。疫苗追溯码代码通过应用标识符将产品标识代码和生产标识代码连接,形成字符串,用二维码GS1 DataMatrix表示,见图11。GS1 Data Matrix的码制规范见GB/T 41208中有关GS1数据矩阵码的有关规定。
Code128条码是一种高密度的条码,可表示从 ASCII 0到 ASCII 127 共128个字符,其中包含数字、字母、符号,故称128条码。GS1-128条码是Code128条码的子集,它是专门授权给GS1使用的,是GS1系统中用于标识附加信息的非定长条码符号。GS1-128条码在字符集和条空规则上与Code128码完全一致。物流单元追溯码代码通过应用标识符连接形成字符串,用一维条码GS1-128表示,见图12。GS1-128的码制规范见GB/T 15425。
6 追溯标识的印制
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6.1 条码印制要求
当疫苗追溯码仅用于零售扫描时,X尺寸为0.396~0.990 mm,四周空白区为X,最低符号等级为1.5/08/660±10;当疫苗追溯码既用于零售又用于常规配送扫描时,X尺寸为0.750~1.520 mm,四周空白区为X,最低符号等级为1.5/20/660±10;当疫苗追溯码仅用于临床使用扫描时,X尺寸为0.254~0.990 mm,四周空白区为X,最低符号等级为1.5/08/660±10。物流单元追溯码的X尺寸为0.495~0.940 mm,左右空白区为10X,条高不小于32 mm,最低符号等级为1.5/10/660±10[5-7]。
6.2 供人识别字符印制要求
疫苗追溯码GS1 DataMatrix二维码供人识别字符一般位于条码符号右侧。物流单元追溯码GS1-128码的供人识别字符通常放在条码符号的上部或下部,校验符不是数据的一部分,不在供人识别字符的格式中显示。供人识别字符推荐选用GB/T 12508中规定的OCR-B字符集,字符内容应与条码中的编码数据内容和顺序完全相同,清晰易读,与条码有明确的联系,且不能占用空白区。应将供人识别字符中的应用标识符用圆括号括起来,已明显区别于其他数据。供人识别字符技术要求的详细内容见《GS1通用规范》(23.0版)第4.14节[8]。
6.3 信息一致性要求
疫苗追溯码中条码和供人识别字符所表示的信息应与疫苗产品包装上的文字信息(如有效期、生产批号等)一致。
6.4 印刷位置要求
印刷时,应避免不同条码标识冲突,位置相对统一且便于扫描,选择适当的条码符号放置方向。零售包装疫苗追溯码放置位置技术要求见GB/T 14257-2009第5章;储运包装疫苗追溯码放置位置技术要求见GB/T 14257-2009第6章;物流单元追溯码放置位置技术要求见GB/T 14257-2009第7章[9]。
7 结论
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追溯标识系统是追溯系统的基础和核心,是实施追溯的前提,贯穿于整个产品追溯过程中。通过对出口疫苗产品包装和物流单元标识疫苗追溯码和物流单元追溯码帮助出口疫苗生产企业建立追溯制度,实现产品生产、流通、使用等环节的信息的追溯,强化出口疫苗产品质量安全监管,强化风险监测预警和有效处置,问题产品召回及原因分析,增强国际市场对中国疫苗安全的信任与认可[9]。
基金
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  • 国家市场监督管理总局技术保障专项——出口疫苗产品追溯标识系统研究与示范项目资助(2022YJ02)
文献
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参考文献 引证文献
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2024年第59卷第5期
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  • 接收时间：2023-04-22
  • 首发时间：2026-04-08
  • 出版时间：2024-03-08
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  • 收稿日期：2023-04-22
基金
国家市场监督管理总局技术保障专项——出口疫苗产品追溯标识系统研究与示范项目资助(2022YJ02)
作者信息
    1 中国物品编码中心, 北京 100011
    2 中国合格评定国家认可中心, 北京 100062
    3 北京嘉华汇诚科技股份有限公司, 北京 100085
    4 中国生物技术股份有限公司, 北京 100024

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*林强,男,博士,高级工程师 研究方向:自动识别技术与追溯系统研究 Tel:(010)84295402;
龙跃,男,高级工程师 研究方向:物联网信息通信实验室认可技术研究 Tel:(010)67105431
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2种不同金属材料的力学参数
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