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Pharma Knowledge Base

ANVISA Expanded Access Program – Brazil

ANVISA EAP PetitionRDC 204/201730 days

Contents

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

Description & Eligibility

ANVISA's expanded access program allows use of unapproved drugs for patients with serious or life-threatening diseases who have no therapeutic alternatives among registered products.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

ANVISA Expanded Access Regulations

Countries Using This Pathway (1)

BR
Brazil
BR
ANVISA Expanded Access Program – Brazil
Approval FormANVISA EAP Petition
Timeline30 days
Legal StatusRDC 204/2017
Source Ref.ANVISA Expanded Access Regulations
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified