NHRA

确保药品完整性:巴林的 NHRA 监管框架

巴林的 NHRA 监管框架

在巴林,国家卫生监管局(NHRA)制定了全面的法规,以保护整个供应链中的药品完整性。NHRA严格的监管框架代表了巴林致力于通过先进的可追溯性和验证系统确保药物真实性、患者安全和供应链透明度。

巴林药品法规的关键原则

双语产品标识和信息

NHRA要求对所有药品使用英语和阿拉伯语进行全面的双语标签。该要求可确保为医疗保健专业人员和患者提供清晰的产品标识和正确的使用说明。每件商品必须包含详细信息,包括药品名称、药物形式、强度、储存要求和制造商详细信息,以增强产品的真实性和正确使用方法。

高级序列化和唯一标识符

巴林的法规要求对所有药品进行符合 GS1 的序列化,确保每个单位都有唯一的标识符。这些数据矩阵代码包含关键信息,包括GTIN(全球贸易项目编号)、批号、到期日期和唯一序列号。这种复杂的识别系统可以精确跟踪整个分销网络,支持供应链的完整性并防止假冒产品进入市场。

集中式可追溯性文档

NHRA-MVC可追溯性中心是巴林药品监管框架的中枢神经系统。所有制造商、进口商和分销商都必须向该集中式系统报告完整的序列化和聚合数据,从而创建端到端的跟踪和追踪能力。这种综合方法有助于实时透明度、伪造检测和高效的产品召回,显著提高患者安全和供应链效率。

强制性汇总和交易报告

巴林的监管框架要求全面维护汇总数据,确保各个单位与其母包装(纸箱、箱子、托盘)之间的关系在整个供应链中保持不变。每笔交易——从收货和包装到运输和分发——都必须仔细记录并提交给 NHRA-MVC 可追溯性中心。这一要求创造了不间断的可见性,增强了供应链的完整性,促进了对安全问题的快速响应。

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

LSPedia 在 NHRA 合规方面的专业知识

驾驭巴林复杂的药品法规需要专业知识和技术能力。LSPedia 提供全面的解决方案,专为寻求实现和维持 NHRA 合规性的公司而设计。我们的平台与现有系统无缝集成,以满足巴林法规规定的所有序列化、汇总和报告要求。从最初的差距分析到完整的系统验证,我们的监管专家团队在整个实施过程中提供量身定制的指导。LspEdia 基于云的软件解决方案提供实时合规性监控、向 NHRA-MVC 可追溯性中心的自动报告以及完整的供应链可见性。通过与LSPedia合作,制药公司可以自信地驾驭巴林的监管格局,同时提高运营效率并保持对患者安全的坚定承诺。

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