"legally distinct".

That should make people's antennas perk up.

For instance. Ford vs Mercury. A Ford Fusion is a Mercury Milan essentially. They are the same car. But they are "legally" distinct.

Why does this matter?

Well let's say you drive a Ford Fusion and live in a certain zip code and your neighbor drives the Mercury, he's right next door.

Your vehicle and his could be same color, cost the same price, both of you with the same driving record, same age, but your insurance with the same company is MORE?

How could that be?

So you call up your insurance company and ask "hey, my neighbor drives the mercury version of my car, same everything, but I'm paying twice the rate!"

And they say

"Well yes, we understand mr customer, but in your zip code Fords are more commonly in accidents than mercury's, so we give you a higher risk rate."

LEGALLY DISTINCT.

Note: This is a very elementary analogy but it delivers the point. "legally distinct" essentially means two very different legal outcomes and paradigms applying to two things essentially "the same".

The entire reason for the "legal distinction" is two fold. To have the headlines of "FDA approval" (which what is available in the US is not!), and also to protect Pharma.