正文
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
