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Bulgaria Compassionate Use (Article 83 EMA)

National compassionate use formRegulated under EU Directive 2001/83/EC30 days

Contents

  1. 1. Description & Eligibility
  2. 2. Countries Using This Pathway

Description & Eligibility

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.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

EMA Article 83 Compassionate Use

Countries Using This Pathway (1)

BG
Bulgaria
BG
Bulgaria Compassionate Use (Article 83 EMA)
Approval FormNational compassionate use form
Timeline30 days
Legal StatusRegulated under EU Directive 2001/83/EC
Source Ref.EMA Article 83 Compassionate Use
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified