ECA新闻20150521：印度药品出口跟踪系统（精彩）

ECA新闻20150521：印度药品出口跟踪系统（精彩）

2015-05-21 22:04:01

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ECA新闻

GMP News
21/05/2015

India's Track&Trace System for the Export of Medicinal Products

印度药品出口跟踪系统

On 1 April the Indian Ministry of Commerce and Industry has supplemented a paragraph that substantiates the actual requirements and the timeline for the implementation of the Track and Trace system for the export of medicinal products. Background is the attempt of the Indian Ministry to make Indian exports of medicinal products and the supply chain more secure.

4月1日，印度商务工业部增加了一段关于药品出口跟踪系统实施时间表和实际要求的说明。原因是印度商工部希望让印度药品出口和供应链更为安全。

Medicinal products produced since 1 April 2015 have to exhibit the following codes or labellings:

自2015年4月1日起，所有在印度生产的药品将带有以下代码或标识：

Primary packaging: The bar code labelling on primary packaging is exempted for the time being. But the 14 digits GTIN along with batch number, expiry date and a unique serial number are to be imprinted in human readable form.

内包：暂时不需要在内包上标识条码。但是14位GTIN与批号、有效期和唯一序列号要印以人眼可识读方式印刷。

Secondary packaging: The secondary packaging is supposed to present a one or two dimensional (1D or 2D) barcode encoding containing the 14 digits GTIN along with batch number, expiry date and a unique serial number.

外包：外包要带有一个一维或两维（1D或2D）条码，赋码信息包括14位GTIN与批号、有效期和唯一序列编号。

Tertiary packaging: The tertiary packaging is supposed to present a one dimensional (1D) barcode encoding containing the 14 digits GTIN along with batch number, expiry date and a unique serial number.

第三层包装：第三层包装要带有一个一维（1D）条码，赋码信息包括14位GTIN与批号、有效期和唯一序列编号。

As of 1 July 2015 the Indian manufacturers are obliged to upload these data on the central portal of the Ministry. The manufacturer is responsible for the correctness, completeness and for ensuring timely upload of data on the central portal. Medicinal products having manufacturing date prior to 1 April 2015 will be exempted from this labelling requirement.

自2015年7月1日，印度生产商必须在一个商务部集中端口上传其数据。生产商有责任纠正、保证完整以及保证及时在集中终端上上传数据。在2015年4月1日之前生产的药品可在免于上述标识要求。

You find the detailed information in the new paragraph 2.89 A

详细信息可以在上述网址找到。