Import Authorization

Workflow steps

1. Import Intent
   You intend to import medicinal cannabis into South Africa. Two pathways: SAHPRA product registration (for registered products) or Section 21 authorization (for unapproved medicines for specific patients).
   • SAHPRA product registration OR Section 21 authorization
   • EU-GMP or PIC/S equivalent required
   • SA customs clearance
2. Registered or Unapproved?
   Is the product SAHPRA-registered or accessed via Section 21? Section 21 allows import of unapproved medicines for specific patients.
3. SAHPRA Product Registration — Registered product
   Full SAHPRA product registration provides commercial-scale supply. Requires full quality, safety, and efficacy dossier.
   • Full registration dossier
   • GMP certificate (EU-GMP or PIC/S equivalent)
   • Product specifications and analytical methods
4. Section 21 Authorization — Unapproved medicine
   SAHPRA Section 21 authorization for unapproved medicines. Import for specific patient on a named-patient basis. Doctor must apply per patient.
   • Doctor applies to SAHPRA per patient
   • Named-patient authorization
   • GMP certificate (EU-GMP or PIC/S equivalent)
   • Product not yet registered in SA
5. Authorization granted?
   SAHPRA evaluates the application. Section 21 applications are typically processed faster than full registrations.
6. Address SAHPRA Queries
   Respond to SAHPRA queries. Common issues: GMP certificate scope, product specification gaps, or clinical justification for Section 21.
7. SA Customs Entry
   SA customs clearance. SAHPRA authorization and all shipping documentation presented.
   • SAHPRA authorization (original)
   • All shipping documentation + COA
   • SA customs declaration
8. Import Cleared ✓
   Shipment released to licensed importer. SAHPRA is a PIC/S observer — working toward full membership.