Create a new submission if:

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


Create an update if:

  • you need to change a published SPC 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); or
  • you want to update and publish a retired SPC 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.