A licensed medicine granted a Marketing Authorisation (MA). Besides, there is a data sheet or Summary of Product Characteristics (SPC) accompany, which is contains indications, dosage, age of patient, method of administration, precautions and other information from the MA. Medicine may only be promoted for the indications and uses in the SPC. Many drugs are prescribed and administered to babies and children outside the terms mentioned in the MA above. These drugs are frequently referred to as 'off-label Medicines'. Many drugs are utilized as off-label, that includes unavailability offormulations for children. The main problem associated with off-label usage is Adverse Drug Reaction (ADR). ADR can happen because of the difference between pharmacokinetics and pharmacodynamics of children and adult. A study showed that ADR happened and caused by 112 of 2881(3.9%) drugs prescribed with the category off-label. A prospective study on doctor's practice in the communities have found that usage of off-label gives ADR with relative risk 3.44; 95% CI 1.26, 9.38. The reason why drugs not permitted for children is the drugs are not tested on children, due to limited funds or difficulties for developing tests and problems with ethics. Scientific evaluation of off-label drug usage can prevent side effects from happening (for instance with prevention of unsuitable dosages). The need for monitoring side effects by using prospective method on children, including children in the communities, to obtain an objective view of the risk and benefit ofpediatric drugs.