European Law – Medicinal products and essential similarity: the preliminary ruling in R v Medicines Control Agency ex parte Generics

The author explains how the European Court of Justice (ECJ) ruling in the case of R v Medicines Control Agency ex parte Generics (Case C-368/96) elucidated the controversial meaning of the concept of essential similarity involved in the authorisation of medicinal products under EC legislation. Article by Dr Frank Wooldridge (University of Notre Dame, London) published in Amicus Curiae - Journal of the Institute of Advanced Legal Studies and its Society for Advanced Legal Studies. The Journal is produced by the Society for Advanced Legal Studies at the Institute of Advanced Legal Studies, University of London.