20160210 ECA新闻：委托监管实施防伪法规的重要文件

20160210 ECA新闻：委托监管实施防伪法规的重要文件

GMP News
10/02/2016

Important Publication of the Delegated Regulation complementing the Anti-Counterfeiting Regulation

委托监管实施防伪法规的重要文件

On 9th February 2016 the European Union has published the "COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use" in the official journal of the European Union.

在2016年2月9日，欧盟在欧盟官方杂志上公布了“委员会委托监管（EU）2016/161于2015年10月2日实施指令2001/83/EC欧洲议会和欧盟委员会制订详细规定以规范人用药品包装上显示的安全信息”。

The most important consequence of this publication is that the date for the implementation of the required measures is now mandatory: all requirements must be implemented by 9th February 2019! This means that the delegated regulation for serialization and verification of the medicinal products concerned must be applied starting 9th February 2019.

此文件最重要的结果是所要求措施的实施日期现在成为强制：所有要求必须在2019年2月9日时实施！这意味着药品序列编号和核实委托监管条例必须自2019年2月9日开始实施。

The final regulation remained almost completely unchanged compared to the draft of this regulation. Compare our news "Draft of Delegated Act regarding Safety Features published".

相比于此法规的草案内容，最终法规仍然保持几乎没有变化。请与我们的新闻“关于安全信息的委托监管法案草案公布”进行比较。

Only in the scope in article 2 a further paragraph 1.c) has now been supplemented that this regulation also applies to medicinal products on which the member states have extended the scope of application of the unique identifier or of the device against manipulation in accordance with article 54a (5) of Directive 2001/83/EC. And in article 9 on bar codes on the packaging a sentence was switched without having any effect, though.

只是在第2条范围里，现在加了一段1.c)，这样此法规也适用于成员国延伸唯一识别码范围的药品，或根据指令2001/83/EC第54a(5)条反伪医疗器械。在关于包装上条码的第9款里，一个句子有点变换，但并没有什么影响。

With the publication of this regulation, a two dimensional barcode (2D barcode) will have to be used as a safety feature in the future. This must be applied on the packaging in readable form.

此法规公布后，将来必须要使用二维码（2D条码）作为安全信息。此要求必须采用可读形式应用于包装上。

Article 6, for example, defines the minimum requirements for the print quality of these two-dimensional bar codes and parameters, which the manufacturer must check in the future.

例如，第6款定义了这些二维码印刷质量的最低要求和参考，将来生产商必须进行检查。

To get the detailed information please see the original COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use.

更详细信息参见上述网址。

http://zhuyujiao1972.blog.163.com/blog/static/98694727201611303341160/

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