Abstract
The number of medicinal products for human use, which are not registered in the Czech Republic but used nevertheless, is constantly increasing. There are various reasons behind the use of unlicensed medicines, notably due to medicine manufacturing and distribution causes.
This problem in the field of paediatrics arises also from the fact that clinical trials involving children are more intricate. So as to minimize medication errors, it is crucial for healthcare professionals as well as the patients and their caregivers to follow the good practice procedures linked with the handling of unlicensed and off-label medicines.
The aim of this article is to provide an overview of management of handling the unlicensed medicines which entails the import of unregistered medicines, specific treatment programs and off-label use along with a few examples from the current paediatric practice.