When assessing a medicinal product for licensing under the abridged procedure the Authority must consider its essential similarity with a product licensed for ten years, of the same constitution both as to structure and proportions and with bio-equivalence.
Times 04-Jan-1999, C-368/96, [1998] EUECJ C-368/96
Bailii
ECTreaty art 177
European
Updated: 24 August 2021; Ref: scu.161988
