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COFEPRIS Compassionate Use Authorization – Mexico

COFEPRIS CU FormGeneral Health Law Article 16730 days

Contents

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

Description & Eligibility

COFEPRIS compassionate use authorization allowing access to unregistered medicines for patients with serious or life-threatening conditions in Mexico.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

COFEPRIS Compassionate Use Guidelines

Countries Using This Pathway (1)

MX
Mexico
MX
COFEPRIS Compassionate Use Authorization – Mexico
Approval FormCOFEPRIS CU Form
Timeline30 days
Legal StatusGeneral Health Law Article 167
Source Ref.COFEPRIS Compassionate Use Guidelines
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified