OrphanDrug
OrphanDrug
Pharma Knowledge Base

Uso Compasivo – Spain (Real Decreto 1015/2009)

AEMPS Compassionate Use FormReal Decreto 1015/200930 days

Contents

  1. 1. Description & Eligibility
  2. 2. Countries Using This Pathway

Description & Eligibility

Spanish compassionate use framework under Royal Decree 1015/2009 allowing access to medicines under investigation or not marketed in Spain for patients with serious or life-threatening conditions.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

AEMPS Compassionate Use Guidance

Countries Using This Pathway (1)

ES
Spain
ES
Uso Compasivo – Spain (Real Decreto 1015/2009)
Approval FormAEMPS Compassionate Use Form
Timeline30 days
Legal StatusReal Decreto 1015/2009
Source Ref.AEMPS Compassionate Use Guidance
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified