OBJECTIVES: Transparency Directive (TD) (89/105/EEC) aims to foster the transparency of measures regulating the pricing and reimbursement decisions of pharmaceuticals in European Union Member States. TD establishes a number of fundamental principles including strict timelines for the pricing and reimbursement (P&R) process. Our study focuses on the implementation of the Transparency Directive in Hungary with special focus on time-limits for P&R decisions. METHODS: We analyzed official decisions in 103 P&R submissions (positive cases with decisions only) made by the National Health Insurance Fund Administration (NHIFA) between 2004 and 2010. Most of the cases belonged to pharmaceuticals with new active ingredients and without reimbursement at the time of submission. We excluded generic drugs and cases without P&R decision from the analysis. In order to determine the market access time we calculated the time period between the registration date of the drug by the European Medicines Agency (EMA) or by the National Institute of Pharmacy (NIP) and the P&R decision. RESULTS: The average time period from registration to P&R decision was 721 days (min: 46 days, max: 2696 days); from registration to P&R submission was 481 days (min: 1 days, max: 2581 days), from P&R submission to P&R decision was 214 days (min: 7 days, max: 990 days). Hungarian patients get access later to those medicines with centralized EMA registration compared with medicines with national registration procedure by NIP (average elapsed time from registration to positive decision was 827 days by EMA, 513 days by NIP). CONCLUSIONS: Periods needed for decisions are generally in accordance with the 90+90 days recommendation of the TD. There is a positive change in pricing and reimbursement process in Hungary; decision procedure was shorter in 2010 than it was in 2004. Hungarian patients get new, better medicines later if the registration was done by EMA.