Skip to content
English
  • There are no suggestions because the search field is empty.

How to remove a product when it shares a combined PIL with other products


If multiple product strengths or presentations share a combined PIL, and one of those products needs to be removed, you must update the combined PIL so it only remains associated with the active products. Follow the steps below:

  1. Select Create submission in the top right corner and choose Update a product or Go to All Products from the left side menu, locate the product, and click Update
    • You will be taken to the product’s Product Group Management screen.
  2. Go to the PIL tab and choose Update for the combined PIL document.
  3. Upload the correct PIL file. You may either:
    • Upload a new PIL file, if you have an updated version, or
    • Upload the same PIL file that is already published if no content changes are required.
  4. After uploading the file, select the products that should remain associated with the combined PIL.
    • Keep selected only the products that will remain active.
    • Unselect any products you want to retire.

  5. Select the appropriate Reason for Submission (for example, product retirement or document association changes).
    • If you used the same PIL file, add a note explaining that the content has not changed, but the presentations [insert product names] are no longer marketed or similar wording.
  6. Submit the update for approval and publication.

Once the update is published:

  • Products that do not have an active associated SmPC will be removed from emc.
  • Products that have an active SmPC will remain available on emc until the associated SmPC is retired.

This ensures you only maintain one combined PIL going forward, keeping your documentation clean and avoiding duplicates.

Can a product be removed even if its content is shared with other products?

Yes. A product can be removed even if its content is shared with other products within the same product group. Removing one product does not affect the other products that share the same document. All remaining products will continue to display the shared content without any impact.