happyjyl
第2楼2008/12/15
“市场销售注册”这种提法不太对,应该是“注册、上市销售”。其实注册就是申请market authorization的过程,拿到market authorization以后才可在欧盟市场上销售。邮件可以这样写:
Dear **,
We plan to market ** (药品名称) in EU region. Please kindly inform whether an on-site inspection shall be conducted and provide some hints on how to prepare for it. Your early reply will be highly appreciated.
Best regards
** (落款)
关于欧盟GMP的现场核查,你可以看看EMEA的网站,上面有很详细的解释:
http://www.emea.europa.eu/Inspections/GMPCompproc.html
文件很多,你可以点击“Zip file”打包下载。