- This topic has 0 replies, 1 voice, and was last updated 1 month, 1 week ago by
.
Viewing 0 reply threads
-
Posts
-
-
Hello,
It is my understanding that Marketed Product Material (artifact 02.01.11) will be generated for TMF filing only if:
1. it is a Phase 4 study or
2. a trial uses a comparator which is already approved for marketing in which case the SmPC is needed only for the comparator and the comparator belongs to the same sponsor.Does anyone have a different opinion/interpretation?
Many thanks
Sagar
-
Viewing 0 reply threads
- You must be logged in to reply to this topic.