Objective Improving access to effective and safe medicines is one of the major goals of all health systems. To achieve this goal, assessment is a fundamental phase of national medicine programs for access improvement. Collecting and compiling applicable indicators and impart a comprehensive framework for assessing access to medicine, are the aims of this study. Methods To investigate the published materials on access to medicines framework or indicators, a literature review with a systematic search was conducted using PubMed/ Medline, Scopus, and Google Scholar databases. The results were completed with a general search of documents in Iran Food and Drug Administration (IRFDA). Two independent researchers reviewed all the articles and documents. Thereafter the related indicators were extracted. In focused group discussion of academics and IRFDA experts, duplicate entries or ineffectual concepts were cleaned from the preliminary indicators. In the next step, Delphi questionnaire was sent to the 17 experts that work in academia, Social Security Insurance, IRFDA, Ministry of Health and Iran Pharmacist Association. The results of Delphi technique were finalized in an expert panel. Results One hundred and thirty one indicators were found in systematic search. After primary extraction of related indicators, 77 indicators were sent to the 17 experts in a Delphi form. The results of Delphi were finalized in a specialized-working group and 67 indicators were accepted in 5 categories including physical availability and geographical accessibility (19 indicators), affordability (23 indicators), human resources (4 indicators), quality and safety (5 indicators), information and rational use (16 indicators). Conclusion The indicators that inclusively assess the full access to medicine in the concept of rational use have been categorized into five categories in this study. To determine the access to medicine status in each country further local surveys are necessary for all several indicators in each category. Keywords Health services accessibility. Access to medicine. Accessibility. Availability. Pharmaceutical services. Health status indicators. BHealth care quality. Access. and Evaluation^. Affordability. BCosts and cost analysis^. Health policy. National medicine program. Pharmaceutical policy