Case C-452/06 ex parte Synthon BV [2008] ECR I-7681

This concerned the failure of MS to implement a directive on drug marketing authorisation.

ECJ reiterated its traditional line from Brasserie, i.e. that there had to be breach of rule of law that was sufficiently serious, and a causal connection, in principle for the national courts to determine whether the conditions for State liability for breach of EC law are met.

• Here the sufficiently serious breach was found in the failure to accord mutual recognition to a marketing authorization already granted in another member State, as had been demanded by the directive.