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RegisterNew FDC - BE reference products [Regulatives / Guidelines]
Dear nobody
As I explained, it is a new fixed dose combination with known APIs, there is no reference product in the strict sense, only mono product references but if you do not aim for substitution indication (according to §10(b)) but go for a mixed application according to §8.3 do you need to demonstrate BE against the European mono products?
Looking forward to your reply.
Kind regards
Dr_Dan
As I explained, it is a new fixed dose combination with known APIs, there is no reference product in the strict sense, only mono product references but if you do not aim for substitution indication (according to §10(b)) but go for a mixed application according to §8.3 do you need to demonstrate BE against the European mono products?
Looking forward to your reply.
Kind regards
Dr_Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- New FDC - BE reference products Dr_Dan 2015-11-03 09:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- New FDC - BE reference products nobody 2015-11-05 15:32
- New FDC - BE reference productsDr_Dan 2015-11-09 08:48
- New FDC - BE reference products nobody 2015-11-10 14:01
- New FDC - BE reference productsDr_Dan 2015-11-09 08:48
- New FDC - BE reference products nobody 2015-11-05 15:32
Ing. Helmut Schütz