The term of 'off label use' is referred to as a treatment applying non- labelled dosages, formulations or age restrictions of medicines. In most European countries, off label use has become a significant and frequently used aspect within the public health care system. Regarding primary health care in particular, off label use is a widespread result of both long lasting labelling processes and insufficient benefits for the pharmaceutical industry.The aim of this study is to illustrate the difficulties and importance of the provision of labelled medicines, as well as regulatory actions required in the European Union and in the United States, in order to solve the problem.Over the past two decades, medicinal treatment for children has changed faster than labelling processes, leading to lacking labelled medicines for children. Concerning several medical fields such as neonatal treatment, rates of off label prescribed medicines, often account for 100%. Based on five commonly off label used examples, this report is outlining common causes of problems, suggestions of solutions, as well as significant characteristics the use becomes off label. The examples are represented by medicines for Migraine treatment, pulmonary hypertension, pain, narcotisation and vomiting. Additionally, both law aspect and risks regarding off label use in children are taken into account, in order to clarify reasons why the problem is mostly affecting children and how a child?s age is related to the rate of such a treatment.