Good Off-Label Use Practice

The EBC actively supports the adoption of EU guidelines on off-label use of medicines, a policy option presented in the European Commission`s Study on off-label use of medicinal products in the European Union published in February 2017. Off-label use is the practice of using a medicine outside its authorised indication. This is often necessary in areas of unmet medical needs but also poses challenges in terms of patient safety. The manner in which member states deal with off-label use is currently not harmonized in the EU.

In recent years some member states have passed legislation that promotes the use of medicines off-label for economic purposes. In this context the EBC, together with other pan-European organizations, supports the Declaration on Good Off-Label Use Practices (GOLUP). This document calls on the European Medicines Agency (EMA) and other national regulatory bodies to adopt strict guidelines on the practice of off-label use, thereby taking steps to ensure that public health is not undermined by economic interests.

Learn more about the declaration, the current signatories and the practice of off-label use in Europe by visiting the GOLUP Website.

Please contact for more information on how to sign on to the declaration.

Promoting good practice for the off-label use of medicines