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Pharma Knowledge Base

Legge 648/96 – Italy Off-Label Reimbursement

AIFA Legge 648 ApplicationLegge 648/9645 days

Contents

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

Description & Eligibility

Italian Law 648/96 allows off-label reimbursement of medicines not yet authorised in Italy for rare diseases or conditions where no valid alternative exists.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

AIFA Legge 648/96 Guidance

Countries Using This Pathway (1)

IT
Italy
IT
Legge 648/96 – Italy Off-Label Reimbursement
Approval FormAIFA Legge 648 Application
Timeline45 days
Legal StatusLegge 648/96
Source Ref.AIFA Legge 648/96 Guidance
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified