Regulatory Submission in Europe in Absence of Reference product [Regulatives / Guidelines]

posted by Abhay Patil – India, 2021-03-23 10:00 (511 d 03:57 ago) – Posting: # 22291
Views: 6,567

Thank you for your quick feedback.
The Individual product are present in Europe for more than 20 years and their equivalent Generics too available and filed under WEU. so in such case is it necessary to do BABE study

Warm regards

Abhay Patil

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! [Ohlbe]

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