OBJECTIVES: To compare the regulatory framework and the structure of the Positive Drug Lists (PDL) in Bulgaria issued in 2003 and 2009. METHODS: Comparative legislation analysis was applied towards the requirements of the newly adopted regulation on PDL in 2008 with the regulation in 2003. It was analysed the requirement to the applicants, including the pharmacoeconomic evidences, selection procedure and the structure of the PDL. RESULTS: Main changes in PDL regulation are the following. In 2003 PDL the medicines were selected according to their innovativeness in one list under INN. In 2008 PDL medicines were separated in 4 lists according to the financing sources – Health Insurance, Hospital, Governmental budget and National Health programs. The criteria for the medicines evaluation were increased (efficacy, effectiveness, safety and pharmacoeconomic) and detailed in the new regulation. The PDL Committee is deciding both reimbursement status and level. The reimbursement level is defined on the basis of the international comparison with reimbursement levels in 7 reference countries calculated as lowest cost per DDD per unit. The changes in the structure of the PDL are the following. In 2003 there were list A with 625 INNs and list B with trade names that were updated on a yearly basis. In 2009 the four separated lists include 575 INNs presented with their trade names and dosage forms together. Reimbursement list 1 include 289 INNs, list 2 (518 INNs), list 3 (101 INNs) and list 4 - 59 INNs. Lots of INNs in all lists are overlapping. Also near 50 combinations are presented in the PDL. CONCLUSIONS: The new PDL includes less INNs as a total number and lots are overlapping between the lists. No National pharmacoeconomic guideline exists both for the PDL committee and manufacturers and thus no evidences for the influence of pharmacoeconomics exist.