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RegisterRegulatory Submission in Europe in Absence of Reference product [Regulatives / Guidelines]
Hi Abhay Patil!
In absence of Innovator product in EU and UK market for FDC, you may have to do BE against individual drug substance innovator product. Please see Guideline on clinical development of fixed combination medicinal products.
Regards,
Dshah
In absence of Innovator product in EU and UK market for FDC, you may have to do BE against individual drug substance innovator product. Please see Guideline on clinical development of fixed combination medicinal products.
Regards,
Dshah
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 productdshah 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 product drgunasakaran1 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 productdshah 2021-03-23 09:51
Ing. Helmut Schütz