Your national competent authority has already accepted a Compassionate Use Programme

The process when a Compassionate Use Programme is already in place

In this situation, it is assumed the company has already evaluated the needs for a compassionate use, its production capacities, and has accepted the programme. National Competent Authorities have also approved the Compassionate Use Programme.

When a cohort programme is agreed, the doctor needs to contact the company in charge (it can be either the pharmaceutical company developing the product, or a clinical research company (CRO) contracted to conduct the CUP) and then the doctor can enrol the patient in the programme (except if supply is limited and all treatments already allocated).

Otherwise, for named-patient programmes, each doctor needs to fill in the form to request a CUP for each patient.

Page created: 30/10/2013
Page last updated: 07/11/2014
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