Justifying Changes to Submissions

For some situations, when you make a change you need to provide a justification for making that change at that time.

For example, when setting up a submission project, you add the countries that the submission covers. When the submission is configured, you promote it. If you find you have to add an additional country, Market Registration lets you do it, but you have to explain why you need to add the country after the submission project is already in process.

You need to provide justification for:

  • Adding countries to a submission that is beyond the Draft state
  • Suspending, resuming, or revoking a market authorization

  1. Click Submit or Done after making your change.
    Market Registration prompts you to justify the change.
  2. Click to enter the effective date of this change.
    Not all situations require you to enter a date. If the dialog box does not contain a date field, the current date is used.
  3. Enter text to describe why you need to make the change at this point of the process.
  4. Click Done.