Andorra

Europe

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Andorra is regulated by the Ministeri de Salut. 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

Ministeri de Salut

Regulatory Pathways (1)

Andorra Special Import (via EMA framework) 14 days

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

Application Form: Andorra 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

Andorra

ISO Code	`AD`
Region	Europe
Regulatory Authority	Ministeri de Salut
Pathways	1 documented
Drugs Available	0 documented