Nepal

South Asia

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Nepal is regulated by the DDA (Department of Drug Administration). 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

DDA (Department of Drug Administration)

Regulatory Pathways (1)

DDA Nepal Special Import Authorization 30 days

Nepal Department of Drug Administration special import authorization for unregistered medicines needed for patients with serious or rare conditions.

Application Form: DDA Special Import Form

Legal Basis: Drug Act 2035 (Nepal)

Eligibility: Serious or life-threatening condition with no locally registered alternative

Reference: DDA Nepal Drug Import Guidelines

Nepal

ISO Code	`NP`
Region	South Asia
Regulatory Authority	DDA (Department of Drug Administration)
Pathways	1 documented
Drugs Available	0 documented