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RegisterRegulatory Submission in Europe in Absence of Reference product [Regulatives / Guidelines]
Dear Abhay Patil,
Yes. We need to conduct studies even though equivalent Individual Product Generics are available in the EU Market.
❝ 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.
Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
Complete thread:
- Regulatory Submission in Europe in Absence of Reference product Abhay Patil 2021-03-23 08:58 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Regulatory Submission in Europe in Absence of Reference product dshah 2021-03-23 09:51
- Regulatory Submission in Europe in Absence of Reference product Abhay Patil 2021-03-23 10:00
- Regulatory Submission in Europe in Absence of Reference productdrgunasakaran1 2021-05-20 07:20
- Regulatory Submission in Europe in Absence of Reference product Abhay Patil 2021-03-23 10:00
- Regulatory Submission in Europe in Absence of Reference product dshah 2021-03-23 09:51
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