Biowaiver criterion <5% (not ≤5%) [Regulatives / Guidelines]

posted by Laura Carreiras – Portugal, 2022-08-12 14:37 (113 d 23:28 ago) – Posting: # 23220
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Dear Helmut,

Thank you for your quick answer.

Well, I agree with your answer, in fact the guideline is clear. In our case, the value is 5.00%, without rounding. We wanted to know if anyone had already been through this situation and if the competent authorities accepted proportionality.

Thanks again.

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

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