Croatia

Europe

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Croatia is regulated by the HALMED (Agency for Medicinal Products 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

HALMED (Agency for Medicinal Products and Medical Devices)

Regulatory Pathways (1)

Croatia Compassionate Use (Article 83 EMA) 30 days

EMA Article 83 compassionate use framework allowing access to unauthorised medicinal products for groups of patients with a chronically or seriously debilitating or life-threatening disease in Croatia.

Application Form: National compassionate use form

Legal Basis: Regulated under EU Directive 2001/83/EC

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

Reference: EMA Article 83 Compassionate Use

Croatia

ISO Code	`HR`
Region	Europe
Regulatory Authority	HALMED (Agency for Medicinal Products and Medical Devices)
Pathways	1 documented
Drugs Available	0 documented