BE waiver for proportional formula [Regulatives / Guidelines]

posted by m.ross – Switzerland, 2018-03-15 12:11 (1321 d 17:11 ago) – Posting: # 18553
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The proportional waiver is for your product and not for the reference. Assuming that there is nothing strange in the labelling of the reference indicating that their two doses are not equivalent (like a statement that 2 x 20mg is not equivalent to 1 x 40mg) then there should be no issue.


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. Please follow the Forum’s Policy[Helmut]

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