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Dear outlaw Torn,
Submission plan as a well-established use is a good plan as the reference was first licensed in the EU in 1960s. Will opt that route and see what happens next.
Thank you for sharing means to find global marketing authorisation of the product. The plan should prevent duplicating the studies with different references from different ICH countries. Has anyone got experience with FDA accepting a study with EU reference and pharmaceutically proving global MAH Status.
Kind regards,
Tina.
Submission plan as a well-established use is a good plan as the reference was first licensed in the EU in 1960s. Will opt that route and see what happens next.
Thank you for sharing means to find global marketing authorisation of the product. The plan should prevent duplicating the studies with different references from different ICH countries. Has anyone got experience with FDA accepting a study with EU reference and pharmaceutically proving global MAH Status.
Kind regards,
Tina.
Complete thread:
- Reference Product decision Tina 2013-04-22 11:40 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EEA: Reference Product Helmut 2013-04-22 13:09
- Reference Product Tina 2013-09-24 14:08
- Reference Product Helmut 2013-09-24 22:53
- Reference Product Tina 2013-09-27 18:02
- Last time: R = innovator Helmut 2013-09-28 09:40
- Reference Product The Outlaw Torn 2013-09-30 08:18
- Reference Product Tina 2013-10-01 14:27
- Reference Product The Outlaw Torn 2013-10-02 08:03
- Reference ProductTina 2013-10-03 11:37
- Reference Product The Outlaw Torn 2013-10-02 08:03
- Reference Product Tina 2013-10-01 14:27
- Reference Product Tina 2013-09-27 18:02
- Reference Product Helmut 2013-09-24 22:53
- Reference Product Tina 2013-09-24 14:08
- EEA: Reference Product Helmut 2013-04-22 13:09
Ing. Helmut Schütz