Reference=originator [Study Per­for­mance]

posted by Dr_Dan  – Germany, 2010-09-22 11:34 (5761 d 09:49 ago) – Posting: # 5930
Views: 5,454

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

Kind regards and have a nice day
Dr_Dan

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