2001/83/EC

beiwei5du

选自2001/83/EC
http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf
出口欧盟的企业（同时过了国内GMP），那么如果被国内CFDA检查缺陷，是不是CFDA必须将该信息发于进口国的相关的监管机构！！

Article 46b
1. Member States shall take appropriate measures to ensure that themanufacture, import and distribution on their territory of activesubstances, including active substances that are intended for export,comply with good manufacturing practice and good distributionpractices for active substances.
2. Active substances shall only be imported if the followingconditions are fulfilled:
(a) the active substances have been manufactured in accordance withstandards of good manufacturing practice at least equivalent to thoselaid down by the Union pursuant to the third paragraph ofArticle 47; and
(b) the active substances are accompanied by a written confirmationfrom the competent authority of the exporting third country of thefollowing:
(i) the standards of good manufacturing practice applicable to theplant manufacturing the exported active substance are at leastequivalent to those laid down by the Union pursuant to thethird paragraph of Article 47;
(ii) the manufacturing plant concerned is subject to regular, strictand transparent controls and to the effective enforcement ofgood manufacturing practice, including repeated andunannounced inspections, so as to ensure a protection ofpublic health at least equivalent to that in the Union; and
(iii) in the event of findings relating to non-compliance, informationon such findings is supplied by the exporting third country tothe Union without any delay.
This written confirmation shall be without prejudice to the obligationsset out in Article 8 and in point (f) of Article 46.
3. The requirement set out in point (b) of paragraph 2 of this Articleshall not apply if the exporting country is included in the list referred toin Article 111b.
4. Exceptionally and where necessary to ensure the availability ofmedicinal products, when a plant manufacturing an active substancefor export has been inspected by a Member State and was found tocomply with the principles and guidelines of good manufacturingpractice laid down pursuant to the third paragraph of Article 47, therequirement set out in point (b) of paragraph 2 of this Article may bewaived by any Member State for a period not exceeding the validity ofthe certificate of Good Manufacturing Practice. Member States thatmake use of the possibility of such waiver, shall communicate this tothe Commission.

胜利者

嘿嘿

beiwei5du

想咨询一下大家某一产品出口欧盟，实际情况下你们省份的药监局真正到你们公司来进行相应产品的GMP审查没有？？？？还是只是一个文件盖章的的过程？？？政府自己将自己的公信力当儿戏耍？？？？

beiwei5du

胜利者 发表于 2016-9-8 21:42
嘿嘿

求指导！