Bulgaria

Europe

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Bulgaria is regulated by the BDA (Bulgarian Drug 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

BDA (Bulgarian Drug Agency)

Regulatory Pathways (1)

Bulgaria 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 Bulgaria.

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

Bulgaria

ISO Code	`BG`
Region	Europe
Regulatory Authority	BDA (Bulgarian Drug Agency)
Pathways	1 documented
Drugs Available	0 documented