【急问】外包装及说明书需要打印二维码吗？

毒手药王邓智先

网友问：

您好，请教您一个问题。我们有个新建口服固体车间（胶囊）需要过FDA认证，但是刚来一个厂家工程师说外包装及说明书需要打印二维码，并且说法规要求的 ，并且2017年生效。我们想知道哪里有这种说法？目前没有查到。谢谢您。

罗伊鲱

http://www.gmp-compliance.org/gm ... hat-was-new-in-2016

Directive 2011/62/EU, the so-called Falsified Medicines Directive and the resulting changes and adjustments in other areas are still reverberating.

The deadline is approaching: As of 2018, security features are mandatory on the packaging of all prescription drugs, but also on those of critical over-the-counter drugs. These security features will allow for their identification and unambiguous tracing. The outer packaging or, if not available, the immediate packaging of any medicinal product must have safety features that make it possible to verify its authenticity and identify individual packages.

This will be implemented via a 2D matrix code that can be read by common scanners (it is recommended to use bar codes that comply with the requirements of the International Organization for Standardisation/International Electrotechnical Commission (ISO/IEC) 16022:2006). The technical and organisational details regarding the security features were published together with the Delegated Regulation (EU) 2016/161 on 9 February 2016.

Eventually, it is an end-to-end verification system. However, potential checks (and deactivations), also at wholesale level, are being discussed depending on the way of distribution.

The code itself should have no more than 50 characters and must be worldwide unique, which can be something of a challenge. This will require considerable efforts throughout the introduction and implementation stage, and some companies need to hurry up in order to meet the deadline.

赵旭锋

现在才2016年5月
既然是厂家工程师说需要二维码，那就让他们提供一下相应的法规原件，自己起研究一下，是否是真的需要
有些公司喜欢曲解一些说法

小金库

学习借鉴，感谢楼主