Uso Compassionevole – Italy (DM 7 settembre 2017)

AIFA Compassionate Use ApplicationDecreto Ministeriale 7 settembre 201745 days

Description & Eligibility

Italian compassionate use under Ministerial Decree of 7 September 2017 for individual patients with serious, rare or life-threatening diseases.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

AIFA DM 2017 Compassionate Use

Countries Using This Pathway (1)

Uso Compassionevole – Italy (DM 7 settembre 2017)
Approval FormAIFA Compassionate Use Application
Timeline45 days
Legal StatusDecreto Ministeriale 7 settembre 2017
Source Ref.AIFA DM 2017 Compassionate Use
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified
Uso Compassionevole – Italy (DM 7 settembre 2017) — Regulatory Pathway | OrphanDrug