FEI编号的申请

jl加油

请问兽药原材料申请FEI编号，需要准备那些资料

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FDA么？期待大神回复。

一沙一叶

1. 公司信息发给FDA GDUFAFEI Request，收到如下回复
Dear ,
Please contact the Electronic Drug Registration and Listing System to register your firm: EDRLS@fda.hhs.gov
2. 根据要求联系EDRLS@fda.hhs.gov后，回复如下：
The establishment registration SPL file needs to be submitted for this location in order to assign the FEI number. Please follow the guidance provided below for submitting registration and listing SPL files.
As of June 1, 2009, FDA no longer accepts paper submissions (forms 2656, 2657, 2658) for registration and listing. If you need to register and/or list with us or renew your existing registration or request a labeler code, you need to use the electronic system. For more instruction on the electronic registration and listing system visit: http://www.fda.gov/Drugs/Guidanc ... sting/ucm078801.htm .
For the Gateway test account:
· If you have any questions/concerns relating to email policy, please contact esgprep@fda.hhs.gov and explain your situation.
· For Registration of Drug Establishment, your center is Office of the Commissioner (OC), not CDER.
· For the fastest service, please send all ESG technical support requests to ESGHelpDesk@fda.hhs.gov.
For technical assistance to prepare your SPLs:
Contact the SPL Coordinator at spl@fda.hhs.gov
Thank you,
eDRLS Team
dm
3. 发送SPL文件后，收到回复
Please provide the name and address of the site location in question along with the Dunns number assigned to this site. The FEI number will be assigned once we’ve received the establishment registration SPL file by the import district office.
Thank you,
eDRLS Team
dm
4. 最后收到回复
Dear ,
Please see the FEI Number for XXXX below highlighted in red:
XXXXXXXXXXXXXX
总之一句话，有任何疑问或没有收到回复积极跟对方邮件联系，FDA回复很快。

jl加油

一沙一叶 发表于 2015-11-23 22:18
1. 公司信息发给FDA GDUFAFEI Request，收到如下回复
Dear ,
Please contact the Electronic Drug Regist ...

谢谢回复，我会好好研究，再次感谢

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