Sri Lanka

South Asia

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Sri Lanka is regulated by the NMRA (National Medicines Regulatory Authority). 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

NMRA (National Medicines Regulatory Authority)

Regulatory Pathways (1)

NMRA Special Import Authorization – Sri Lanka 21 days

Sri Lanka National Medicines Regulatory Authority special import authorization for unregistered medicines for patients with serious medical needs.

Application Form: NMRA SIA Form

Legal Basis: National Medicines Regulatory Authority Act

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

Reference: NMRA Drug Import Guidance

Sri Lanka

ISO Code	`LK`
Region	South Asia
Regulatory Authority	NMRA (National Medicines Regulatory Authority)
Pathways	1 documented
Drugs Available	0 documented