What happens when I complete and submit the Solution Submission Form Part 2, to apply for the label?

Once you complete and submit the SSF online (inlcluding the second part of the SSF), our Technical Team will review the information you have provided to ensure minimum standard of quality and eligibility scope are satisfied (pre-screening). The Technical Team will eventually come back to you if clarifications, modifications. or sentence/paragraph rewrites are needed, you will have 14 days to make these edits to your SSF online.

If your application is validated, it will be sent to the three external, independent Experts for evaluation; at this stage is no longer possible for you to modify or re-submit your dossier.

Was this article helpful?

Still have more questions? get in touch with us