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Unit Level Traceability
Sellable units are uniquely identified enabling a more granular traceability.
OneScan for EU FMD
Did you know that OneScan supports EU FMD compliance? Register here to receive information about our EMVS Software Development Kit that extends the capabilities of our industry leading OneScan platform for European markets.
Global Regulations
Unit Level
Aggregation
Aggregation
The packaging hierarchy of products is required to be identified and documented.
Labelling
Labelling
Products are required to display information in writing.
Central Reporting
Central Reporting
The traceability documentation is required to be centralized in a unique system.
Since 2013, the Falsified Medicines Directive has coordinated supply chain safety measures across the European Union to prevent counterfeit and dangerous products from reaching patients. Its provisions include use of a unique identifier and anti-tampering devices on packaging, use of a medicine verification system, a common logo for legal online pharmacies, stronger rules on import of pharmaceutical ingredients, and record-keeping requirements for wholesale distributors.
《欧盟伪药指令》（FMD）是欧盟实施的全面监管框架，旨在应对药品供应链中日益增长的假冒药品威胁。该指令自2019年2月9日起生效，旨在通过确保药品的真实性和可追溯性来增强患者安全。
欧盟 FMD 的关键条款包括强制在处方药包装上使用安全功能，包括唯一标识符和防篡改设备。唯一标识符由序列化的 2D 数据矩阵代码组成，该代码包含基本的产品信息，例如批号、到期日期和唯一序列号。药剂师和供应链中的其他利益相关者在向患者分发药物之前，必须验证这些标识符的真实性。
此外，欧盟FMD建立了欧洲药品验证系统（EMVS），这是一个安全的数据库，可促进对整个欧盟的药品进行实时验证。制造商、批发商和其他供应链参与者必须连接到 EMVS 以验证和验证药品，从而防止假冒或不合格产品的分销。
通过实施这些措施，《欧盟伪造药品指令》旨在保护公众健康，维护药品供应链的完整性，并增强对在欧盟内部流通的药品安全性和有效性的信任。遵守这些法规对于制药行业的所有利益相关者维护最高质量和患者福祉标准至关重要。
下载 EMVS SDK 数据表
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