Tags

Exception

 

In case of Generic Products: In preparing the dossier for generic products, it is acknowledged that certain modules or sections of the CTD would generally not be applicable and should be marked as such (and not to be deleted). The data requirements for each application will differ, depending on the drug submission type Module 4: Non-Clinical Study Reports Generally not applicable for generic products, however some exceptions may apply.  

 

Exception Link

Specific Class of Exception

generic products

Regulation