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

posted by drgunasakaran1  – 2021-05-20 07:20 (496 d 01:04 ago) – Posting: # 22360
Views: 3,460

Dear Abhay Patil,

» 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

Yes. We need to conduct studies even though equivalent Individual Product Generics are available in the EU Market.

Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.

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