Regina v Licensing Authority Established by the Medicines Act 1968 (Acting by the Medicine Control Agency) Ex P Generics (Uk) Ltd (Er Squibb and Sons Ltd, Intervening Etc: ECJ 3 Dec 1998

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
ECTreaty art 177

Updated: 24 August 2021; Ref: scu.161988