Reference=originator [Study Performance]
Dear all
For a generic product the marketing authorisation applications reference must be made to the dossier of a reference medicinal product for which a marketing authorisation is or has been granted on the basis of a complete dossier. In other words: The reference product is always the innovator product.
Kind regards
Dan
For a generic product the marketing authorisation applications reference must be made to the dossier of a reference medicinal product for which a marketing authorisation is or has been granted on the basis of a complete dossier. In other words: The reference product is always the innovator product.
Kind regards
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:
- Ref vs. Ref kishor 2010-08-19 08:41
- Ref vs. Ref janmacek 2010-08-27 09:20
- Ref vs. Ref Cmax 2010-08-27 19:50
- Ref vs. Ref patilatu 2010-09-22 05:58
- Reference=originatorDr_Dan 2010-09-22 09:34