Montenegro

Europe

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Montenegro is regulated by the CALIMS (Centre for Authorisation and LIM Standards). 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

CALIMS (Centre for Authorisation and LIM Standards)

Regulatory Pathways (1)

Montenegro Compassionate Use Authorization 30 days

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

Application Form: Montenegro CU Application Form

Legal Basis: Regulated

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

Montenegro

ISO Code	`ME`
Region	Europe
Regulatory Authority	CALIMS (Centre for Authorisation and LIM Standards)
Pathways	1 documented
Drugs Available	0 documented