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Pharma Knowledge Base

Health Canada Special Access Program (SAP)

HC/SC 3011 SAP Request FormSection C.08.010 Food and Drug Regulations5 days

Contents

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

Description & Eligibility

Health Canada's SAP allows manufacturers to sell drugs not approved in Canada to practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

Health Canada SAP Guidance

Countries Using This Pathway (1)

CA
Canada
CA
Health Canada Special Access Program (SAP)
Approval FormHC/SC 3011 SAP Request Form
Timeline5 days
Legal StatusSection C.08.010 Food and Drug Regulations
Source Ref.Health Canada SAP Guidance
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified