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Shanxi: traceability system for selected drugs

May 13th, 2022 | by

Recently, the Shanxi Provincial Drug Administration issued a “Notice on Further Work on the Construction of Traceability Systems for Selected Drugs.” According to the Notice, all pharmaceutical enterprises must establish a sound drug tracability management standard, as well as build their own drug tracing system in accordance with national standards or use a third-party drug tracing platform. When secondary and tertiary medical institutions warehouse selected drugs, they must provide drug information to upstream distributors and cannot warehouse drugs that do not match their tracability information. When there are problems with drug quality and safety, medical institutions should work with drug manufacturers and upstream suppliers to record and provide information for drug recalls.

山西部署年底实现重点药品全过程可追溯

2022.05.13  来源:国家重要产品追溯体系

近日,山西省药监局发布《关于进一步做好重点品种信息化追溯体系建设工作的通知》。《通知》指出,生产企业和经营企业要建立健全的药品追溯管理制度,按照国家标准自建或者选用第三方平台建立药品信息化追溯系统。《通知》要求,使用重点品种的二级及以上医疗机构在药品入库时将药品信息反馈上游企业,严禁将追溯信息和实物不相符的药品入库。药品出库时应更新药品状态。当发生药品质量安全问题和风险时,各医疗机构应配合药品生产企业及上游供货企业,记录并提供药品召回流向信息。

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