Off-label use of registered medicinal products

Off label use of medicinal product is defined as the 1) use outside of the registered indication or 2) within those indications, but in the population of patients that are not included in the summary of product characteristics (SmPC). It has a different frequency and extent depending on the indication, population of patients and the country. It is estimated that it relates to 7,5–15% internal diseases patients with typical ambulatory indications, 30–50% cancer patients and up to 90% of those in neonatology and paediatric oncology wards. Every doctor has ethical and legal obligation to perform his duty according to the current medical standards including the off label use of the medicinal products if the new indications were proven on unquestionable way. Unfortunately in the current legal status, when taking this decision he also takes the risk of covering the eventual compensation claims of patients resulting from adverse events of medicinal products used outside of the registered indications. Among other tasks the role of medical societies is preparation of current therapeutic recommendations that can help in taking decisions related to the use of medicinal products outside of the registered indications.