If you’re getting ready for UFI/PCN submissions, here’s something you might want to consider early on:
“If we want to add more products, do we save anything by doing it now?”
My quick answer to this question is mostly yes. As this sounds a bit strange, I’ll explain by reviewing a couple of real situations I’ve seen.
First, let’s say, you have multiple trade names for the same formulation.
If that is your case, you can include them all in one PCN notification right there and then. That saves you from paying additional fees later as we have additional work we could have avoided.
But if the formulations are different, each one requires its own dossier. In this case there’s no cost difference whether you submit them now or later. We have to do the whole PCN process separately anyway.
How about if you’re still finalizing your product list?
In this case I would recommend gathering all trade names that are linked to a formulation upfront. This would actually be a variation of the first approach I mentioned above. But this small step can prevent unnecessary costs down the line.
It is such small insights on how to approach UFI and PCN notifications that result in measurable savings at the end. So, it’s worth taking the time to think about the most favorable approach for you.
Have questions about how this might apply to your specific products? I’m happy to walk you through it.
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