This report by WHO gives an overview on the use of licensed medicines for indications that have not been approved by regulatory authorities. It provides a scientific summary of key aspects to consider in off label use of medicines and the need to adhere to national regulations on the use of medicines. It also stipulates the ethical considerations that must be observed during clinical trials and highlights the need to ensure that essential supplies required to treat other diseases should not be compromised by stockpiling medicine for off-label use.