ORGANIZATION: State Institute for Drug Control (SUKL) is Czech medicines agency. PROBLEM OR ISSUE ADDRESSED: The method for setting levels and conditions of reimbursement has been changed in the Czech Republic since the year 2008. Unlike previous practice, the information on reimbursement is not published by decree of the Ministry of Health. The levels and conditions of reimbursement are set up on a case-by case basis within administrative proceedings. Under the amended Act No. 48/1997 Coll., the Ministry of Health prepares legal regulations (laws, decrees) and acts as the appellate authority in administrative proceedings. The State Institute for Drug Control (SUKL) is the authority of first instance which decides on the levels and conditions of reimbursement. GOALS: Derivation and implementation of process scheme that is law-abiding and suitable for specific price and reimbursement decisions. OUTCOMES ITEMS USED IN THE DECISION: National legislation, decisions on pricing and reimbursement of pharmaceuticals. IMPLEMENTATION STRATEGY: In order to develop law-abiding, transparent and effective process a standard model of proceeding was derived based on the legal time limits. A time limit of 75 days is prescribed for adoption of a decision in administrative proceedings. The time limit for joined proceedings covering both the maximum price and levels and conditions of reimbursement is set to 165 days. The possibility to appeal against the decision of SUKL or initiate judicial review has been considered the key point granting the process is legal and just. RESULTS: The right to appeal came out as one of the dominant factors that extended the length of administrative proceedings. Furthermore some complications of procedural character (e.g. an obligation to provably deliver all documents to all participants of the proceedings even if their domicile is in foreign countries) emerged which then led to extension of duration of the administrative proceedings. This problem was recently solved by legislation change. At the same time the need for specialized administrative schemes that would quickly address the situation with market shortages or provision of fully reimbursed medicines arose. LESSONS LEARNED: The right to appeal against decisions on price and/or reimbursement emerged as a factor that predominantly affects the duration of administrative proceedings, but is not under reconsideration. On the other hand the current discussion tends toward alternative ways of deciding the reimbursement (e.g. tenders) in some special groups of pharmaceuticals.