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[摘要]
美国食品药品管理局(FDA)于2018年9月发布了供企业用"药品供应链安全法(DSCSA)规定的产品标识符问答指导原则(草案)",回答了药品包装上粘贴或印刷产品标识符的许多具体问题,指出了对不同容器上产品标识符的类型(线性条形码和2D数据矩阵条形码)的不同要求。详细介绍该指导原则,期望对我国药品包装这方面的进一步规范和完善有所启发。
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[Abstract]
FDA issued Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers Guidance for Industry (draft),in September 2018. This document answers many specific questions about product identifiers affixed or imprinted on drug packaging, and points out the different requirements for the types of product identifiers (linear bar code and 2D data matrix bar code) on different containers. This paper introduces the guidance in detail and is expects to be enlightening to the further development and perfection of this aspect in our country.
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