Chestnye Znak

推进药品安全:俄罗斯的 Chestny ZNAK 可追溯系统

推进药品安全

在俄罗斯,Chestny ZNAK系统代表了一个全面的国家跟踪和追踪框架,旨在确保药品真实性并打击假冒药物。这一强大的监管体系于2017年12月根据第425-FZ号联邦法律建立,自2019年以来已分阶段实施,创建了世界上最严格的药品追溯网络之一,旨在保护公共健康和确保供应链完整性。

Chestny ZNAK 可追溯系统

俄罗斯 Chestny ZNAK 可追溯系统的关键原则

全面的序列化和加密安全

Chestny ZNAK要求每种药品都必须具有唯一的二维数据矩阵代码,其中包含关键标识符,包括全球贸易项目号(GTIN)、随机序列号、批次信息、到期日期和FEACN代码。最值得注意的是,每个代码都包含一个 44 个字符的加密安全元素,从而创建了复杂的数字护照,可在产品的整个生命周期中伴随其使用。

端到端供应链可见性

该系统通过每次所有权转让的强制性报告,实现从生产到销售点的全面可见性。透视技术研究中心(CRPT)向制造商或进口商发布独特的代码,所有后续行动都将在联邦州药物流通监测信息系统(FSISMDC)中进行跟踪。这种全面的方法可以实时监控药品并快速识别违规行为。

严格的验证和停用

当药品到达药房、医院或诊所时,必须先进行扫描并在Chestny ZNAK系统中注册,然后才能分发。销售点扫描过程有效地使产品停止流通,防止未经授权的转售或用假冒产品替代。这种验证机制扩展到消费者,他们可以使用Chestny ZNAK移动应用程序对产品进行身份验证。

严格的合规框架,处以重大处罚

俄罗斯建立了严格的合规框架,违规行为将产生重大后果。在某些情况下,不遵守Chestny ZNAK的要求可能会导致市场排斥、巨额罚款,甚至监禁。这一执法机制凸显了俄罗斯对药品安全和患者安全的承诺。

Why Choose Our iTS Compliance Solution

Expert Guidance

Our team of compliance experts possesses in-depth knowledge of iTS and Turkish pharmaceutical regulations. From serialization strategies to data reporting, we guide your organization through the intricacies of compliance, ensuring a smooth and informed journey.

Cutting-Edge Technology

Leverage our state-of-the-art compliance solution, designed to integrate seamlessly with iTS requirements. Our technology ensures accuracy, efficiency, and real-time visibility, empowering your organization to meet and exceed compliance expectations.

Future-Ready Operations

Compliance is not just about meeting today's standards; it's about preparing for the future. Our solution is designed to evolve with regulatory changes, ensuring that your organization remains at the forefront of compliance in the dynamic Turkish pharmaceutical landscape.

Transparent Collaboration

We believe in transparent collaboration. Partner with us, and we'll work closely with your team to implement and maintain compliance measures. Our goal is to build a resilient, compliant, and future-ready pharmaceutical supply chain together.

Speak With a Compliance Expert

我们在Chestny ZNAK合规方面的专业知识

驾驭俄罗斯复杂的药品可追溯性格局需要专业知识和复杂技术。LSPedia的全面合规解决方案旨在应对Chestny ZNAK系统的独特挑战。我们的平台可以与FSISMDC报告基础设施无缝集成,确保准确的加密代码管理,并促进区分俄罗斯系统的强制性聚合要求。从实施合规的序列化系统到管理外国制造商的广泛报告需求,我们的团队在整个合规过程中提供端到端的支持。凭借LSPedia的专业知识,制药组织可以自信地驾驭俄罗斯严格的监管环境,同时保持运营效率并确保不间断的市场准入。

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