European Compassionate Use Programs

We host a weekly virtual Water Cooler Chat series, where our subject matter experts host informal discussions around a number of clinical supply hot topics. This week we are discussing European Compassionate Use Programs

In this Water Cooler Chat whitepaper, our experts – Tris Evans, VP of Global Clinical Quality, Gavin Morgan, Senior Manager of Global Logistics and Uday Pathapati, Senior Manager of Clinical Project Management – discuss what factors need to be considered from a quality, packaging and labeling, logistical and risk management perspectives when planning an EU Compassionate Use Program.

Compassionate use supplies in Europe are unlicensed medicines and not the 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

Download our “European Compassionate Use Programs” whitepaper (PDF)


We provide a complete range of clinical trial services and we are committed to supporting clients at every stage of the clinical cycle, delivering best-in-class services efficiently and effectively.

Find out more about our clinical trial services.

Our dedicated team of specialists will be happy to discuss any of your clinical trial service needs. Contact us on +1 779-208-1819 (US) or +44 1495 711 222 (UK/EU) or email