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[FDA药事] DMF授权信有无有效期?

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药徒
发表于 2019-3-4 11:45:33 | 显示全部楼层
这个是官网的授权信模板授权信中会明确授权的DMF编号(我理解的DMF NO.是DMF文件编号,而非归档号),如果DMF发生变更,编号会改变,相当于授权信就不再适用了。



Letter of Authorization 2015-04-14.doc

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www.8317.org彩云小说网  发表于 2020-1-5 14:18
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药徒
发表于 2019-3-4 12:37:28 | 显示全部楼层
LETTERS OF AUTHORIZATION (Category 2)

All Letters of Authorization (LOAs) should be submitted in two copies to the DMF, if the DMF is in paper format.  If the DMF is in CTD format, whether in paper or eCTD, the LOA should be submitted in Section 1.4.1.  A copy of the LOA must then be sent by the DMF holder to the Authorized Party (company or individual authorized to incorporate the DMF by reference).  Failure to submit the original LOA to the DMF may result in a delay in review of the DMF. LOAs should specify the name of the specific item being referenced and the date of the submission of information about that item. The LOA should not be called a “Letter of Access.”
An LOA should be submitted even if the DMF holder is the same company as the authorized party.
LOAs should NOT be submitted with original paper DMFs (unless the DMF has received a pre-assigned number) because the LOA should contain the DMF number. Therefore, if there is no pre-assigned number, DMF holders should wait before submitting an LOA until they have received an acknowledgment letter containing the DMF number.
It is not necessary to reissue LOAs if there have been no changes in the holder, authorized party, subject of the DMF or item referenced.
If the holder changes its name, whether this represents a change in ownership or not, new LOAs should be submitted to the DMF and copies sent to the authorized party(ies).
If an authorized party changes its name, the new authorized party should request a new LOA from the DMF holder.  Failure to do so may result in a delay in review of the DMF.

If there has been a name change, it is not necessary to submit a Withdrawal of Authorization Letter for the holder or authorized party’s previous name.
If a company has a Master File submitted to another Center in the FDA, e.g. a Biologics Master File (MF) submitted to the Center for Biologics Evaluation and Research, the Letter of Authorization should be submitted to the Master File in that other Center rather than CDER.
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