OrphanDrug
OrphanDrug
Pharma Knowledge Base
DO

Dominican Republic

DO

Caribbean

Contents

  1. 1. Regulatory Overview
  2. 2. Regulatory Pathways

Regulatory Overview

Dominican Republic is regulated by the SESPAS (Secretaría de Estado de Salud Pública y Asistencia Social). 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

SESPAS (Secretaría de Estado de Salud Pública y Asistencia Social)

Regulatory Pathways (1)

Dominican Republic MOH Special Import Authorization 30 days

Dominican Republic Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Application Form: MOH Dominican Republic Special Import Form
Legal Basis: Regulated
Eligibility: Serious or life-threatening condition with no locally registered alternative
DO
Dominican Republic
ISO CodeDO
RegionCaribbean
Regulatory AuthoritySESPAS (Secretaría de Estado de Salud Pública y Asistencia Social)
Pathways1 documented
Drugs Available0 documented