Lithuania

Europe

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Lithuania is regulated by the VVKT (State Medicines Control 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

VVKT (State Medicines Control Agency)

Regulatory Pathways (1)

Lithuania 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 Lithuania.

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

Lithuania

ISO Code	`LT`
Region	Europe
Regulatory Authority	VVKT (State Medicines Control Agency)
Pathways	1 documented
Drugs Available	0 documented