欧盟公布关于安全方面的委托条例草案

20151007 ECA新闻：欧盟公布关于安全方面的委托条例草案  

Draft of Delegated Act regarding Safety Features published
欧盟公布关于安全方面的委托条例草案
The European Union has published the draft of the delegated act. This document deals with the technological and organisational requirements for the safety features that have to be considered in the future for prescription medicines in accordance with the counterfeiting directive.
欧盟刚公布了委托条例的草案。该文件是在将来处方药品符合防伪法案中要考虑的安全方面技术和组织化要求。
The document contains 34 pages, and, in addition the Annexes I - IV.
文件包括34页，另外还有附录I-IV。
In the future a system is supposed to be established which ensures the identification and authentication of medicinal product by an "end-to-end" verification. For certain medicinal products with a higher counterfeiting risk additional verifications are supposed to take place at the wholesalers.
在将来，要建立一个体系采用“点到点”核查来确保药品鉴别和认证。对于具有较高被伪造风险的特定药品，则需要批发商处进行额外的认证。
As characteristic a two-dimensional (2D) barcode is supposed to be used - which must be attached to the packaging in readable form.
将要采用二维码作为识别工具，必须将其以可读形式附入包装中。
The monitoring authorities will also be allowed to get access to the information regarding the security characteristics of the medicinal product.
监管当局将被允许获取关于药品安保方面的信息。
Chapter I defines which medicinal product must bear this safety feature. The technical specifications are presented in Chapter 2. The two-dimensional bar code shall comply with at least the quality of the data matrix code ECC200 and shall be of adequate quality. The more detailed requirements can be found in Chapter 6.
第一章指出了哪些药品必须具备这些安全特征。技术标准放在第二章。二维码应至少符合ECC200关于数据矩阵码的质量要求，并具备足够的质量。更多细节要求可以在第六章找到。
For further details please see the complete draft of the Commission Delegated Regulation (EU).
更多细节参见“委员会委托条例（EU）”完整草案。
来源：
http://zhuyujiao1972.blog.163.com/blog/static/9869472720159824546412/

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