San Marino

Europe

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

San Marino is regulated by the AASS (Azienda Autonoma di Stato per i Servizi Sanitari). The country has 1 documented regulatory pathway for accessing unapproved or unlicensed medicines, covering named patient programs, compassionate use schemes, and special access arrangements.

Regulatory Authority

AASS (Azienda Autonoma di Stato per i Servizi Sanitari)

Regulatory Pathways (1)

San Marino Special Import (via EMA framework) 14 days

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

Application Form: San Marino Special Import Form

Legal Basis: Via EU/EMA regulatory framework

Eligibility: Serious or life-threatening condition with no locally registered alternative

Reference: EMA Article 83 Compassionate Use

San Marino

ISO Code	`SM`
Region	Europe
Regulatory Authority	AASS (Azienda Autonoma di Stato per i Servizi Sanitari)
Pathways	1 documented
Drugs Available	0 documented