Britain’s MHRA has released a guideline covering “baseline submissions.” A baseline submission refers to submission of all current valid documents along with a statement that the content has not changed, only the format. “For transparency reasons and ease of process, it is recommended that baselines are applied when there are no pending regulatory activities for the product,” the guideline states. Baseline submissions are usually required when converting the format used for submission of procedures and/or correcting technical issues relating to previously supplied documents in the current submission format.
[/membership][membership level=”0,4″][The content continues for paid members only.]
Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership]
