Ukraine

Europe

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Ukraine is regulated by the SMCU (State Medicinal Centres of Ukraine). 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

SMCU (State Medicinal Centres of Ukraine)

Regulatory Pathways (1)

SMCU Compassionate Use Program – Ukraine 21 days

Ukraine State Medicinal Centres compassionate use program allowing access to unregistered medicines for patients with serious or life-threatening conditions.

Application Form: SMCU Compassionate Use Application

Legal Basis: Ukraine Drug Regulation Law

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

Reference: Ukraine MOH Drug Access Guidelines

Ukraine

ISO Code	`UA`
Region	Europe
Regulatory Authority	SMCU (State Medicinal Centres of Ukraine)
Pathways	1 documented
Drugs Available	0 documented