关于EU防伪法案新的CMDh问答文件

New CMDh Q&A Document on the Implementation of the EU Falsified Medicines Directive

关于EU防伪法案新的CMDh问答文件

In March CMDh published a new Q&A document to provide further guidance on the implementation of the EU Falsified Medicines Directive. The title reads "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive".

3月，CMDh发布了一份新的问答文件，为EU防伪药品法案提供进一步指南，题为“CMDh在实施防伪药品法案方面收到问答的澄清”。

The answers confirm the very flexible, independent and phased in approach as preparation for the 2D Code and anti-tampering. How to deal with mock-ups and the different approaches in the Member States is discussed in several Q&As.

回答中确认了二维码和防伪准备中的灵活、独立和渐进方式。在几个问答中还讨论了如何处理成员国内模型和不同方法。

The document also indicates that the safety features can already be implemented, even if the respective variation application has not been approved. However, requests for variations should be submitted as early as possible.

文件还指明了即使对应的变更申报还没有批准时已经可以实施的安全特征。当然，变更申报还是要尽早提交。

The document finally confirms that everything related to the safety features on packaging has to be implemented until 9 February 2019

文件最后确认了与包装上安全特征相关的所有方面必须在2019年2月9日之前实施。

You can find the complete"CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive" here.

完整内容可以在上述网址找到。

来源：julia

谢谢分享！！！！！！！！！！！！

谢谢分享！！！！！！！！！！！！

楼主，好，请问有没有最新的关于标签和药品说明书的最新法规要求，现在我手里有一版2009年1月12日的，谢谢