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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?

刊登日期:2021-11-17  |  點閱次數 : 194 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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