Dear Joseph,
I do not know international law.
But I can tell you something about the German law which is very strict.
We say that every step ("packing") counts as production.
We have the case of re-imports.
This means: German drug are produced e.g. for Spain or Greece. There the
selling price is cheaper than in Germany.
If the same product is on the German market some companies buy it in Spain
for the cheaper price and bring it back to Germany.
But for distribution in Germany we need a German package insert by law.
So this company has to re-pack it -> and now they are producers. They have
made "a new product": the re-import.
Yours sincerely,
Hans-Ruediger