CMDh公布关于QR代码的立场文件

20150212 ECA新闻：CMDh公布关于QR代码的立场文件  

2015-02-13 19:07:36|  分类： ECA新闻|

GMP News
12/02/2015

CMDh Position Paper on QR Codes Published

CMDh公布关于QR代码的立场文件

http://www.gmp-compliance.org/enews_04674_CMDh-Position-Paper-on-QR-Codes-Published.html

In April 2014, the European Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) published a position paper on the use of QR codes on the outer packaging and the package leaflet of medicinal products.

在2014年4月，欧洲人药互认和非集中审评程序协作组(CMDh)曾公布了一份关于在药品外包装和包装说明书上使用QR代码的表明其立场的文章。

Basically, there is the possibility to use symbols and pictograms as part of the identification to highlight and clarify significant facts.

使用符号和图标作为识别信息的一部分，对重要情况进行强调和澄清，基本上来说是可行的。

In the future, the use of QR codes will be possible and will apply to both prescription and over-the-counter medicinal products.

在将来，使用QR代码将成为可能，且会应用于处方药和OTC药。

According to the position paper of the CMDh, the QR codes can deliver product information as well as additional risk minimisation indications. Thanks to the QR code, the patient always has access to the latest update of the package leaflet. Yet, a corresponding note should appear to avoid eventual irritation among the patients because of discrepancies between the different versions of the package leaflet.

根据CMDh的立场文章，QR代码可以传达药品的信息，以及降低风险。多亏了QR代码，患者总能获得最新更新的包装说明书。但，应该要出一份对应的注解，以避免由于不同版本包装说明书之间的差异而最终让患者生气。

The position paper only refers to QR codes to access websites containing information about the medicinal products. It clearly distinguishes from other barcodes like those used as measures against counterfeits.

立场文章只提到了QR代码可以进入含有药品信息的网站。它与用来防伪的条码有明显区别。

The paper also includes indications about the position of the QR code.

该文章还包括了关于QR代码位置的说明。

The use of a QR code must be declared in the marketing authorisation application; for authorised products, a notification must be sent to the regulatory authorities.

使用QR代码必须在上市许可申报中进行说明，对于已批准的上市药品，必须向药监机构发送一份通知。

For further information please see the complete CMDh position paper entitled "Position Paper on the Use of QR Codes to provide Information about the Medicinal Product."

更多信息请参见CMDh完整文章，题为“提供药品相关信息的QR代码的使用”。

来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201511393619732/

好消息，谢谢分享