North Macedonia

Europe

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

North Macedonia is regulated by the MALMED (Medicines and Medical Devices Agency). 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

MALMED (Medicines and Medical Devices Agency)

Regulatory Pathways (1)

North Macedonia Compassionate Use Authorization 30 days

North Macedonia regulatory authority compassionate use authorization for unregistered medicines for patients with serious or life-threatening conditions.

Application Form: North Macedonia CU Application Form

Legal Basis: Regulated

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

North Macedonia

ISO Code	`MK`
Region	Europe
Regulatory Authority	MALMED (Medicines and Medical Devices Agency)
Pathways	1 documented
Drugs Available	0 documented