FAQ
Drugs

On the API Registration and DMF Refuse to File (RTF) checklist, what information should be provided for item 2 on the Type II checklist regarding referenced DMF?

刊登日期:2021-11-17  |  點閱次數 : 457 次 

Copy of DMF approval letter or DMF number for a DMF which has been approved by TFDA and is within the validity period should be provided. In addition, power of attorney letter issued by the API manufacturer along with a statement that there have been no changes to the manufacturing process should also be provided. An API license alone may not be used as the basis for referencing an approved DMF. If an API manufacturer has applied for changes to the DMF previously, change approval letter(s) must be submitted along with the application.

 

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