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Pharma Knowledge Base
MC

Monaco

MC

Europe

Contents

  1. 1. Regulatory Overview
  2. 2. Regulatory Pathways

Regulatory Overview

Monaco is regulated by the Ministry of Health (ANSM via France). 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

Ministry of Health (ANSM via France)

Regulatory Pathways (1)

Monaco Special Import (via EMA framework) 14 days

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

Application Form: Monaco 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
MC
Monaco
ISO CodeMC
RegionEurope
Regulatory AuthorityMinistry of Health (ANSM via France)
Pathways1 documented
Drugs Available0 documented
Monaco — Drug Regulatory Pathways & Orphan Drug Access | OrphanDrug