Objectives: The aim of this study was to examine the justification for the deregulation of Over-the- Counter (OTC) medicinal products containing active substance acetylsalicylic acid (ASA), registered in the Republic of Croatia, from Pharmacy Only to Pharmacy and Drug Outlet Medicinal Products. Material and Methods: A comparative review was made of the regulatory status of OTC medicinal products containing active substance ASA in a selected number of EU member states. We analysed the legislation on distribution of OTC medicinal products in the Republic of Croatia and compared reported adverse reactions of medicinal products with active substances ASA, ibuprofen or paracetamol reported in the Republic of Croatia in the year 2015. Results: Medicinal products classified as Pharmacy and Drug Outlet Medicinal Products have permission to advertise to the general public. OTC medicinal products containing the active substance ASA also have permission to advertise to the general public. Analysis of adverse events reported with medicinal products containing active substances ASA, ibuprofen or paracetamol found that there were no significant differences in the number of reported adverse reactions classified as serious. There was no statistically significant difference in the outcome of the adverse reactions among these medicinal products. Conclusions: There was no difference in reported adverse reactions among medicinal products containing active substance ASA, ibuprofen or paracetamol, therefore there is no obstacle for the deregulation of OTC medicinal products containing active substance ASA, registered in the Republic of Croatia, from Pharmacy Only to Pharmacy and Drug Outlet Medicinal Products. A reagulatory framework should be developed to address this deregulation.