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RegisterBiowaiver criterion <5% (not ≤5%) [Regulatives / Guidelines]
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]
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]
Complete thread:
- Biowaiver criteria - 5% Laura Carreiras 2022-08-12 12:03 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Biowaiver criterion <5% (not ≤5%) Helmut 2022-08-12 12:17
- Biowaiver criterion <5% (not ≤5%)Laura Carreiras 2022-08-12 12:37
- Biowaiver criterion <5% (not ≤5%) wienui 2022-08-16 18:22
- Biowaiver criterion <5% (not ≤5%)Laura Carreiras 2022-08-12 12:37
- Biowaiver criterion <5% (not ≤5%) Helmut 2022-08-12 12:17
Ing. Helmut Schütz