Difference Between New and Updated Submissions?

Create a new submission if:

• you have an SmPC or PIL that has never been published on emc website before
• you are adding an individual SmPC or PIL that was previously published as a combined document.

Create an update if:

• you need to change a published SmPC or PIL/X-PIL (Note: there is no need to submit an update if you just want to change the title of the document on emc, but not any text in the document itself; see Naming documents section)
• you want to update and publish a retired SmPC or PIL/X-PIL.
  
  

When you approve and publish an update, the previous version is automatically retired. Please do not manually retire the previous version since all your document history will be lost.