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RegisterBA BE Study with a reference not market authorised [Regulatives / Guidelines]
Hi Rick,
This is a regular type II variation or a line extension depending on whether P stays on the market after you introduce NF.
If you are not the MA holder for P then the situation is not in any way straightforward. At the end of the day the reference should be an article 8 approved product and judging from your question P might not be?!??. Let us hear some more details, please. Ideally name the RF product
Can you elaborate on the passage "(...) it is not authorised": What does "it" refer to, is it P, NF or RM?
❝ I have a new formulation (NF) of a product (P) that has been demonstrated to be BE to a reference Marketed (RM) product, but it is not authorised. And I want to demonstrate BE of my new formulation (NF) vs the product (P) already BE to the Market authorised (RF).
This is a regular type II variation or a line extension depending on whether P stays on the market after you introduce NF.
If you are not the MA holder for P then the situation is not in any way straightforward. At the end of the day the reference should be an article 8 approved product and judging from your question P might not be?!??. Let us hear some more details, please. Ideally name the RF product
Can you elaborate on the passage "(...) it is not authorised": What does "it" refer to, is it P, NF or RM?
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- BA BE Study with a reference not market authorised Rick 2017-10-10 16:20 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BA BE Study with a reference not market authorisedElMaestro 2017-10-10 17:09
- BA BE Study with a reference not market authorised Rick 2017-10-11 09:07
- BA BE Study with a reference not market authorisedElMaestro 2017-10-10 17:09
Ing. Helmut Schütz