Study on off-label use of medicinal products in the European Union.

This report describes the results of the study on the complex field of off-label use; the terms under which a product can be used safely and effectively are described in the product information. The study covers the public health aspects related to the off-label use of medicinal products, and in particular the balance between its benefits and risks for patients, and the regulatory framework for the off-label use of medicines.
The general objective of the study is to provide a description of existing and foreseen practices of off-label use across Member States and a factual analysis of all parties’ positions towards the existing measures and possible envisaged tools to regulate the off-label medicine use at national level.