Minimum requirements are the requirements imposed on clinical and economic analyses, as well as analyses of impact on the budget of the entity obliged to finance healthcare services from public funds, which are submitted by the marketing authorization holder as part of the reimbursement process. Detailed requirements are set forth in the Regulation of the Minister of Health dated 2 April 2012 on the minimum requirements for the analyses included in applications for providing reimbursement and establishing an official selling price and increasing an official selling price for a medicinal product, foodstuff for particular nutritional purposes or medical device that has no reimbursed equivalent for the particular indication.
Should the analyses submitted under the reimbursement procedure be found not to meet the minimum requirements, the President of the Agency shall request that the applicant supplement the analyses using the Reimbursement List Service System (RLSS) and designate a 21-day deadline for supplementing the documentation. Deadlines for the verification analysis are suspended during this period of time.
*Ladies and Gentlemen
We inform you that the materials and results of the discussions posted on the Agency’s website are the result of the conceptual work and analytical process carried out by the team of the Agency for Health Technology Assessment and Tariff System based on the EBM paradigm, including: search, selection, synthesis and interpretation of scientific evidence, or the data analysis carried out .
In connection with the above, we would like to inform you that the use of analytical material or the results of the discussion, in accordance with good practice, should be accompanied by information on the source in the form: [title of presentation / report], AOTMiT, Warsaw, June 2021]