Poland

Europe

Contents

1. Regulatory Overview
2. Regulatory Pathways
3. Available Drugs

Regulatory Overview

Poland is regulated by the URPL (Office for Registration of Medicinal Products). 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

URPL (Office for Registration of Medicinal Products)

Regulatory Pathways (1)

Poland 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 Poland.

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

Drugs Available (1)

Drug	Access Route	Status	Lead Time
Diosmin	—	—	—

Poland

ISO Code	`PL`
Region	Europe
Regulatory Authority	URPL (Office for Registration of Medicinal Products)
Pathways	1 documented
Drugs Available	1 drug(s)