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SAHPRA Section 21 Authorization – South Africa

SAHPRA Section 21 ApplicationMedicines Act Section 2130 days

Contents

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

Description & Eligibility

SAHPRA Section 21 of the Medicines and Related Substances Act allows use of unregistered medicines when no suitable registered alternative exists, for named patients or in defined settings.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

SAHPRA Section 21 Guidance

Countries Using This Pathway (1)

ZA
South Africa
ZA
SAHPRA Section 21 Authorization – South Africa
Approval FormSAHPRA Section 21 Application
Timeline30 days
Legal StatusMedicines Act Section 21
Source Ref.SAHPRA Section 21 Guidance
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified