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.