20150715 ECA新闻：书面证明：以色列和巴西现在也被列入“第三国清单”

20150715 ECA新闻：书面证明：以色列和巴西现在也被列入“第三国清单”

GMP News
15/07/2015

Written Confirmation: Now also Israel and Brazil on the "Third Countries List"

书面证明：以色列和巴西现在也被列入“第三国清单”

Since 2 July 2013, each API delivery from a non-EU country to the EU must be accompanied by a GMP compliance certificate ("Written Confirmation"). With this certificate the authority of the exporting country confirms that it has a control system to comply with GMP standards that is equivalent to the control system binding in the EU and that the exported batches of the API were manufactured according to these standards.

自2013年7月2日起，所有从非欧盟国家发往欧盟的原料药都必须出具一份GMP符合性证明（书面证明）。通过该证明，出口国的药监机构证明具备有控制系统来保证其GMP标准相当于欧盟所要求的控制系统，出口的原料药批是根据这些标准所生产的。

Article 111b of Directive 2001/83/EC allows an exemption, though: third countries can request a review of their systems for the monitoring and enforcement of GMP standards with the European Commission. If the review is positive the country is added on a "third countries list". This "third countries list" is part of an EU Commission Decision that is updated when further countries are added to the list. This decision usually becomes effective on the twentieth day following its publication in the official journal of the European Union.

指令2001/83/EC第111b条允许有豁免的情形。根据豁免条款，第三国可以申请对其欧洲员会GMP标准的监测和实施体系进行审核。如果审核结果OK，则该国会被增加进一份“第三国清单里”。

The inclusion of Israel and Brazil in this list took place a few days ago with the release of the "COMMISSION IMPLEMENTING DECISION (EU) 2015 / 1057 of 1 July 2015 amending Implementing Decision 2012/715/EC of establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the included control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union".

以色列和巴西是欧盟发布评估结果后，在最近几天被加入该清单的。

More third countries - such as New Zealand and South Korea - have also asked for the exemption and are currently being reviewed, so that it can be expected that the list will be further extended in the near future.

更多第三国家---例如新西兰和韩国----已申请了豁免，现在正在审核中。因此可能在不久的将来会被加入清单。