On the API Registration and DMF Refuse to File (RTF) checklist, what is the scope of APIs for which the Type IV checklist is applicable for?

刊登日期：2021-11-17 | 點閱次數 : 474 次

Based on the announcement no. 1031413543 issued on February 24, 2015, Type IV checklist is applicable to APIs with CEP/COS certificate issued by EDQM except sterile API, biological API, and API manufactured by fermentation or of plant origin.

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	On the API Registration and DMF Refuse to File (RTF) checklist, what information
	On the ANDA Refuse to File (RTF) checklist, Item 3 of annex checklist 5 states “

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On the API Registration and DMF Refuse to File (RTF) checklist, what is the scope of APIs for which the Type IV checklist is applicable for?

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