Portugal

Europe

Contents

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

Regulatory Overview

Portugal is regulated by the INFARMED (National Authority of Medicines and Health 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

INFARMED (National Authority of Medicines and Health Products)

Regulatory Pathways (1)

Portugal 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 Portugal.

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 (2)

Drug	Access Route	Status	Lead Time
diacerein	—	—	—
Diosmin	—	—	—

Portugal

ISO Code	`PT`
Region	Europe
Regulatory Authority	INFARMED (National Authority of Medicines and Health Products)
Pathways	1 documented
Drugs Available	2 drug(s)