OBJECTIVES: On the May 1, 2004 Hungary – together with many European countries – joined the European Union which resulted in several changes in the Hungarian legislation. In the coverage policy of pharmaceuticals, the Directive 89/105/EEC of the Council of the European Communities on Transparency was implemented in Hungary, in order to provide regulation on decision on drug prices. The aim of our study is to calculate the average delay of decision-making on pharmaceutical reimbursement. METHODS: The data derive from the drug reimbursement database of the National Health Insurance Fund Administration (OEP) of Hungary covering the 3 year period of 2005-2007. We calculated the delay as the time between the submission of application by the manufacturer and the first day of reimbursement of drug. Our analysis covered drugs submitted within the frame of normal procedure, drugs submitted in the simplified procedure were omitted. RESULTS: Between 2005-2007, the total number of applications was 172, 161, 140; while the average delay was 217, 255, 166 days respectively. Most of the application represented new (innovative) drugs (70, 75, 65 pieces) or new indications of drugs already reimbursed in other indication (27, 28, 27 pieces). Between 2005-2007 the average delay for new (innovative) drugs was 258, 222, 166 days, while for new indications it was 194, 319, 203 days respectively. CONCLUSIONS: The introduction of EU transparency directive provided a strong regulatory framework for decision-making process on drug reimbursement. In the normal procedure we found significant differences in time delay of decision according to submission categories. However, in 2007 the average delay significantly decreased compared to previous years.