San Marino Special Import (via EMA framework)

San Marino Special Import FormVia EU/EMA regulatory framework14 days

Description & Eligibility

San Marino special import authorization for unregistered medicines using the EMA/EU regulatory framework via neighboring EU country channels.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

EMA Article 83 Compassionate Use

Countries Using This Pathway (1)

San Marino Special Import (via EMA framework)
Approval FormSan Marino Special Import Form
Timeline14 days
Legal StatusVia EU/EMA regulatory framework
Source Ref.EMA Article 83 Compassionate Use
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified
San Marino Special Import (via EMA framework) — Regulatory Pathway | OrphanDrug