European Compassionate Use Programs: What Are The Quality And Distribution Considerations?

Compassionate use supplies in Europe are unlicensed medicines and not traditional clinical trial supply. As such the quality and distribution considerations are different for compassionate use supplies in Europe. This article will provide an overview on:

• QP requirements & expectations
• Importing compassionate use medicines into the UK & EU
• Relabeling of compassionate use material
• The role of the healthcare physician
• Bona Fide checks
• Compassionate use supply distribution