翻译：JULIA 来源： Julia法规翻译
26.07.2017
EMA non-compliance report on Indian manufacturer ofsterile medicinal products
EMA
给印度无菌药品生产商的不符合报告
Non-compliance reports are published in the EudraGMDPdatabase of the European Medicines Angency (EMA) by European supervisoryauthorities. They refer to inspections inside as well as outside of theEuropean Union. The non-compliance reports are independently submitted into thedatabase by National Competent Authorities via a standardised form. Forthe company concerned, a non-compliance report has severe consequences untilthe violations are rectified. Amongst other things, a suspension of themarketing authorisation as well as recalls of the products in question could bemandated.
欧洲监管机构签发的不符合报告会发布在
EMA
的
EUGMDP
数据库中。其中列出了对欧盟内外场所实施的检查。不符合报告是由各国家药监机构通过标准格式上传至数据库的。对于受检公司来说，不符合报告会有严重的后果，直至违规行为被纠正。此外，受影响的药品上市许可可能会被搁置，产品可能会被召回。
On July, 5th 2017, the EMA published a non-compliancereport on the Indian company Biocon Limited in Bangalore, which was inspectedby the French supervisory agency "French National Agency for Medicines andHealth Products Safety". During a pre-approval inspection, they observed
35deviations
in 3 Biosimilar-products,
11 of which were major deviations
concerning the following topics:
2017
年
7
月
5
日，
EMA
发布了一份印度公司
BIOCON
的不符合报告。该公司是由法规药监进行的药品批准前检查，检查中发现
35
项生物类似物缺陷，其中
11
项为主要缺陷，相关缺陷领域如下：
