Background: Patient information leaflet (PIL) which accompanies medicinal products and informs patients about dosage, side effects, etc., is known as a tool which empowers patients to be more involved in making decisions related to their medications and health. In recent years, policy makers have paid much attention to PIL and its lay-friendliness i.e. being clear, explicit, and easy to read and understand. In various countries, PIL is known as a legal genre and must be prepared in understandable language. The present study aimed to situate PIL within its institutional context and investigate the importance is given to the lay-friendliness of PIL in Iran. Methods: In this observational study, official website of Food and Drug Administration of the Islamic Republic of Iran (IFDA) was consulted. Iran's rules and regulations, legal requirements, linked to PIL production and translation were introduced and discussed in relation to lay-friendliness. Results: Limited legislation relevant for the production and translation of lay-friendly PIL was found. The IFDA has not issued any documents or guidelines which exclusively concern lay- friendliness of PIL. Any methods which can assess lay-friendliness in original and translated PILs were not observed. Conclusion: The IFDA, the authoritative body in charge of legislation concerning PIL, has given limited importance to the language used in PIL and its lay-friendliness, witnessed by the limited legislation which is relevant for the production and translation of easy-to-understand PIL. It is not clear that how the IFDA assesses quality and lay-friendliness of original and translated PILs.