序列化不是一刀切的。由于美国、欧盟、亚洲和中东的规定各不相同,公司必须应对复杂的要求网络。您为全球合规做好准备了吗?
如果你热衷于有所作为并在协作环境中茁壮成长,LspEdia 就是你的不二之选。
Baptist Health 如何利用 Lspedia 的 OneScan 套件实现 DSCSA 合规性和运营效率
本页综合概述了整个中东和非洲的药品法规。每个列出的国家都简要介绍了其监管框架,可以直接获得更深入的细节。该中心旨在阐明MEA的不同合规期望,重点介绍该地区的新兴要求和既定标准。
Armenia stands at the forefront of pharmaceutical supply chain modernization through its comprehensive e-Mark electronic marking system. As a member of the Eurasian Economic Union (EAEU), Armenia is strategically developing its track and trace regulatory framework to align with international standards while ensuring robust protection against counterfeit medicines. The country's phased approach to implementation demonstrates a commitment to building a transparent and secure pharmaceutical ecosystem that safeguards public health through advanced digital oversight mechanisms.
In Kyrgyzstan, the implementation of robust pharmaceutical track and trace regulations represents a significant step forward in ensuring public health protection and supply chain integrity. The country has adopted a comprehensive approach that encompasses pharmaceuticals, consumer goods, and agricultural products, establishing a sophisticated regulatory framework that aligns with international GS1 standards while addressing the unique needs of the Central Asian market.
Uzbekistan enforces pharmaceutical serialization through its national system called XTrace, managed by CRPT Turon. All human medicines must carry serialized GS1 DataMatrix codes issued by the government. The country recently introduced significant changes to serial number format and reporting rules, including removal of the UZF0 segment and the introduction of a mandatory 7 prefix for serial numbers. Manufacturers, importers and distributors must generate compliant serial numbers, report all movements and ensure strict alignment between printed codes and submitted data for customs clearance.
在哈萨克斯坦,商品标记和可追溯信息系统(IS MPT)是该国确保药品完整性的综合框架。该集中式数字系统由哈萨克斯坦电信股份公司运营,采用先进的跟踪技术来打击假冒药物,提高供应链透明度,并保护全国制药领域的公共健康。
阿塞拜疆通过其强制性药品跟踪和追踪系统,已成为药品安全的区域领导者。在卫生部分析专业中心的监控下,该国的建立 “强有力” 的监控管道框架,在确认保全个药品供应链的完全透明度和制度下。这一综合系统代表了阿塞拜疆致命于通过防范假药.net 维持最高的药品完整性标准来保护公共健康。
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