ECA新闻20150603: EU GMP新附录21正在制订中 （转载）

ECA新闻20150603: EU GMP新附录21正在制订中 （转载）

2015-06-03 21:38:57

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ECA新闻

GMP News
03/06/2015

EU GMP: new Annex 21 on the Way

EU GMP新附录21正在制订中

The GMP/GDP Inspectors Working Party is planning to implement a new Annex to the EU GMP Guidelines with a concep paper on new duidance or importers of medicinal products.

GMP/GDP检查工作组计划实施一个新的EU GMP指南附录，是关于药品进口商的新指南。

Medicinal products, which are manufactured in third countries and imported into the EU, can only be imported into the EU if the importer holds a manufacturing authorisation (MIA). Those products need to be tested and then certified by an EU Qualified Person. Both are defined being a manufacturing step. Here an MIA is needed as well. As a consequence, more than one licence might be needed, if various sites are involved. The new Annex 21 now wants to give more detailed guidance on these activities.

在第三国生产并进口到欧盟的药品时，进口商必须持有生产许可（MIA）。这些药品需要进行检测然后由一个欧盟的QP放行，这两种活动都被定义为生产步骤。如果牵涉到不止一个场所，可能还需要不止一个许可。新的附录21现在就是要给出关于该活动的详细指南。

Another issue that might need further clarification is the term 'import' and what goes along with it.

另一个需要进一步澄清的问题是术语“进口”以及与之相随的问题。

So the main goal of such a new annex is to "provide additional guidance on the GMP requirements that are of particular relevance to importers and on the extent those requirements apply to the different entities involved in importation activities".

所以，这个新的附录的主要目的是“提供与进口商相关的特别GMP要求，以及适用于进口活动中牵涉的不同实体的这些要求的程度的附加指南”。

Stakeholders are now welcome to give their opinion on the concept paper. End of consultation (deadline for comments) is 29 August 2015. Comments should be sent to adm-gmdpATema.europa.eu. However, ECA will conduct a survey amongst its members to provide a consolidated feedback.

现在欢迎干系人提供概念文件的观点，征求意见截止时间为2015年8月29日。意见应发送至上述邮箱，ECA会在其会员中进行调查提交整合后的反馈。

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