OrphanDrug
OrphanDrug
Pharma Knowledge Base
MD

Moldova

MD

Europe

Contents

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

Regulatory Overview

Moldova is regulated by the AMDM (Agency of Medicines and Medical Devices). 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

AMDM (Agency of Medicines and Medical Devices)

Regulatory Pathways (1)

Moldova MOH Special Import Authorization 30 days

Moldova Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Application Form: MOH Moldova Special Import Form
Legal Basis: Regulated
Eligibility: Serious or life-threatening condition with no locally registered alternative
MD
Moldova
ISO CodeMD
RegionEurope
Regulatory AuthorityAMDM (Agency of Medicines and Medical Devices)
Pathways1 documented
Drugs Available0 documented