SOP for Local Import and Export Permits for Investigational Products and Samples

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SOP for Local Import and Export Permits for Investigational Products and Samples

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Published on 22/12/2025

Local Import and Export Permits for Investigational Products and Samples SOP

Department Clinical Research
SOP No. CS/SAHPRA-IMP/187/2025
Supersedes N.A.
Page No. 1 of 24
Issue Date 28/08/2025
Effective Date 05/09/2025
Review Date 05/09/2027

Purpose

This SOP defines the process for obtaining, managing, and maintaining local import and export permits for investigational products (IPs) and biological samples in South Africa. It ensures compliance with SAHPRA regulations, customs requirements, and international GCP standards to safeguard clinical trial supply chain integrity.

Scope

This SOP applies to all sponsor-led clinical trials in South Africa requiring importation of investigational medicinal products (IMPs), comparators, placebos, and export of biological samples for analysis. It covers permit applications, renewals, customs clearance, CRO/vendor roles, and document archiving. It applies to sponsors, CROs, investigators, and regulatory affairs teams.

Responsibilities

  • Sponsor: Ensures all IP shipments and biological sample exports have valid permits before transportation.
  • Regulatory Affairs (RA): Prepares and submits applications to SAHPRA and Department of Agriculture, Forestry and Fisheries (DAFF) if applicable.
  • Logistics Manager: Oversees customs clearance and shipment documentation, ensuring compliance with approved permits.
  • Principal Investigator (PI): Confirms receipt of imported IPs and ensures site-level documentation is maintained.
  • Quality Assurance (QA): Verifies that all permits and shipment logs are complete and inspection-ready.
  • CRO: Provides support in coordinating logistics, customs, and document filings when delegated.
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Accountability

The Sponsor’s Head of Regulatory Affairs is accountable for ensuring all permits are valid and compliant with South African regulations. The PI is accountable for maintaining records of IPs and biological sample movement at the site level.

Procedure

1. Pre-Application Assessment

  1. Determine whether the shipment requires an import or export permit under SAHPRA guidelines.
  2. Document details in Import/Export Requirement Form (Annexure-1).

2. Permit Application

  1. Prepare dossier including protocol, product details, MSDS, GMP certificate, and justification.
  2. Submit permit application to SAHPRA electronically.
  3. Record submission reference number in Permit Application Log.

3. Customs Clearance

  1. Ensure shipments align with approved permits, including labeling and documentation.
  2. Maintain Shipping Tracker capturing customs clearance details.

4. Renewal and Amendments

  1. Initiate renewal process 60 days prior to permit expiration.
  2. Submit updated protocol or supply details for significant amendments.

5. Documentation and Archiving

  1. File permits, clearance receipts, and shipping records in TMF.
  2. Archive documents for 15 years or per SAHPRA guidance.

Abbreviations

  • SAHPRA: South African Health Products Regulatory Authority
  • IP: Investigational Product
  • IMP: Investigational Medicinal Product
  • MSDS: Material Safety Data Sheet
  • PI: Principal Investigator
  • RA: Regulatory Affairs
  • QA: Quality Assurance
  • CRO: Contract Research Organization
  • TMF: Trial Master File

Documents

  1. Import/Export Requirement Form (Annexure-1)
  2. Permit Application Log (Annexure-2)
  3. Shipping Tracker (Annexure-3)
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References

Version: 1.0

Approval

Prepared By Checked By Approved By
Name: Rajesh Kumar
Date: 20/08/2025
Signature: __________		 Name: Sunita Reddy
Date: 22/08/2025
Signature: __________		 Name: Dr. Meera Iyer
Date: 28/08/2025
Signature: __________

Annexures

Annexure-1: Import/Export Requirement Form

Protocol No. Material Permit Required Reviewer Date
SA-2025-01 Investigational Product Yes Rajesh Kumar 05/08/2025

Annexure-2: Permit Application Log

Date Protocol No. Application Ref Status Submitted By
10/08/2025 SA-2025-01 SAH-IMP-001 Under Review Sunita Reddy

Annexure-3: Shipping Tracker

Date Protocol No. Shipment No. Customs Ref Status Owner
20/08/2025 SA-2025-01 IMP-2025-05 CUST-3456 Cleared Neha Sharma

Revision History

Revision Date Revision No. Revision Details Reason for Revision Approved By
28/08/2025 1.0 Initial SOP for local import/export permits for IPs and samples. New SOP created for SAHPRA regulatory compliance. Head of Clinical Research

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