MEB 49: Compassionate Use Programme
Medicinal products can only be marketed if a marketing authorisation has been granted. In cases of compassionate use, medicinal products for which no marketing authorisation has yet been granted may be made available to a group of patients suffering from a serious disease for which there is no authorised medicinal product. To this end, manufacturers of medicinal products can submit an application to the Medicines Evaluation Board for approval of a Compassionate Use Programme (CUP).