Case C-201/94 R. v The Medicines Control Agency, ex parte Smith & Nephew Pharmaceuticals Ltd; Primecrown Ltd v The Medicine Control Agency [1996] ECR I – 5819

The holder of an original marketing authorisation issued under the procedure referred to in Directive 65/65 may rely on the provisions of that directive in proceedings before a national court in order to challenge the validity of an authorisation issued by the competent national authority on the basis of Directive 65/65 to one of its competitors for a proprietary medicinal product bearing the same name.

The same applies where the authorisation, although issued under another procedure laid down at national level, should have been issued on the basis of the directive.

• I.e. administrative decisions can be challenged by virtue of the fact that, had they used the proper procedure under an unimplemented directive, they would have been taken differently.