OBJECTIVES: Transparency Directive (TD) of the European Union aims to ensure the transparency of procedures for the pricing and reimbursement of medicinal products by Member States. TD proposes strict timelines for the pricing and reimbursement process and indicates the necessity of objective and verifiable criteria for decisions and the availability of remedies for negative decisions. Our objective was to compare the routine process of pharmaceutical pricing and reimbursement with the TD in Hungary. METHODS: We analysed official resolutions of 29 pricing and reimbursement submissions by the National Health Insurance Fund (NHIF) between January and June 2008. In 14 cases the NHIF granted reimbursement, in 15 cases the reimbursement claim was rejected. We calculated the time period between the submission of the reimbursement dossier and the official decision. We assessed the consistency of applying objective and verifiable criteria in positive or negative decisions. RESULTS: The average time period for pricing and reimbursement procedure was 172 days (min: 43 days;  max: 534 days). We could not justify the consistency of employing objective and verifiable criteria in the pricing and reimbursement resolutions of innovative pharmaceuticals. CONCLUSIONS: The pharmaceutical pricing and reimbursement process in Hungary is neither transparent nor predictable. There are several open pricing and reimbursement submissions without resolution for long period. Although we could analyse only cases with resolution, the time period for pricing and reimbursment decision was still longer in several cases than 90+90 days recommended by TD. The appropriate use of scarce public health care resources could not be justified in case of positive decisions and there is no remedy for negative reimbursement decisions. TD has been implemented only partially in Hungary.