Major Update Submission

When you create a major update submission, you create an event and, optionally, a sequence. Links to create assemblies and edit PDSs (for all but ELP-only users) are provided as well. To create a major update submission, an application must exist for the product family and country.

Application countries:

• If additional CMS countries have been added that are not already part of the application, they are added to the application.
• If CMS countries that are part of the application are removed from the CMS list, they are not removed from the application.

The Countries attribute on the event is set as follows:

• For national internal procedure type applications, automatically associate the reviewing country on the selected application with the event.
• For CP internal procedure type applications, automatically associate the EU Country with the event.
• For MRP internal procedure type applications, the Reviewing Country/RMS on the selected application and the CMSs selected in the wizard are associated with the event.