Compassionate Use (CU) and Medical Need

The application procedure for implementing a programme which provides medicines for use in cases of distress is described in Articles 106-107 of the royal decree dated 14 December 2006.

A request for approval should be made with the Federal Agency for Medications and Medical Products (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten, FAGG). A favourable opinion from a designated ethics committee is required during the submission process.

Patients may be included in the program if approved by the Federal Agency for Medications and Medical Products (FAGG). Notification is made to the local ethics committee through a study coordinator or physician from the study department concerned.

For more information, please go to the website for the Federal Agency for Medications and Medical Products (FAGG).