Tanzania

Africa

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Tanzania is regulated by the TMDA (Tanzania Medicines and Medical Devices 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

TMDA (Tanzania Medicines and Medical Devices Authority)

Regulatory Pathways (1)

TMDA Special Import Permit – Tanzania 30 days

Tanzania Medicines and Medical Devices Authority special import permit for unregistered medicines for patients with serious medical needs.

Application Form: TMDA Special Import Form

Legal Basis: Tanzania Food, Drugs and Cosmetics Act

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

Reference: TMDA Drug Import Guidelines

Tanzania

ISO Code	`TZ`
Region	Africa
Regulatory Authority	TMDA (Tanzania Medicines and Medical Devices Authority)
Pathways	1 documented
Drugs Available	0 documented