Romania

Europe

Contents

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

Regulatory Overview

Romania is regulated by the ANMDMR (National Agency for Medicines 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

ANMDMR (National Agency for Medicines and Medical Devices)

Regulatory Pathways (1)

Romania 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 Romania.

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	—	—	—

Romania

ISO Code	`RO`
Region	Europe
Regulatory Authority	ANMDMR (National Agency for Medicines and Medical Devices)
Pathways	1 documented
Drugs Available	1 drug(s)