Please tell us the reasons why you are making the new or updated submission. You can add more than one reason, but only one at a time.
For SPC updates - add all the SPC section headings where there have been text changes.
For PIL updates - since there are no standard headings, pick the best section headings to reflect the changes.
If a section heading isn’t listed, please contact servicedesk@datapharm.com and we can either add it to the list or advise you which heading to choose.