Norway

Europe

Contents

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

Regulatory Overview

Norway is regulated by the NOMA (Norwegian Medicines 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

NOMA (Norwegian Medicines Agency)

Regulatory Pathways (1)

Norway 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 Norway.

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
Occupational and Physical Therapy Support	—	—	—

Norway

ISO Code	`NO`
Region	Europe
Regulatory Authority	NOMA (Norwegian Medicines Agency)
Pathways	1 documented
Drugs Available	1 drug(s)