Pharmaceuticals - The Norgine Case and EC Directive 65/65

In an Article 177 ruling of 5 October 1995 (Norgine Limited, case C-400/93), the European Court of Justice held, against the opinion of the U.K. government and the EC Commission, that national authorities have a limited discretionary power when they issue a marketing authorisation for a pharmaceutical product under the abridged procedure of Article 4(2)(8)(a)(ii) of EC Directive 65/65 (O.J. 1965, L22/369, as most recently amended by EC Directive 93/39, O.J.1993, L214/22).

Directive 65/65 lays down the rules on authorisation to put a medicinal product on the market. It provides that no medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State. Under this Directive, an application for authorisation has to be accompanied by a number of documents which include the results of physico-chemical, biological or microbiological tests, pharmacological and toxological tests and