SOP for Import Licenses for Investigational Products and Biological Samples

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SOP for Import Licenses for Investigational Products and Biological Samples

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“keywords”: “import license SOP Brazil, clinical trial import permits ANVISA, SOP for IP import Brazil, SOP for biological sample import Brazil, ANVISA import/export SOP, SOP for trial supply licenses Brazil, clinical trial material import SOP, SOP for ANVISA customs clearance, SOP for CRO import management, investigator responsibilities import Brazil, SOP for sponsor obligations import licenses, SOP for Brazilian trial governance, ANVISA IP import requirements, SOP for import documentation Brazil, SOP for site supply import Brazil, inspection readiness SOP import Brazil, SOP for import license tracker, regulatory compliance SOP Brazil, SOP for IP shipping licenses, biological material customs SOP Brazil, SOP for supply

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Published on 21/12/2025

Import Licenses for Investigational Products and Biological Samples SOP

Department Clinical Research
SOP No. CS/ANVISA-IMP/184/2025
Supersedes N.A.
Page No. 1 of 24
Issue Date 28/08/2025
Effective Date 05/09/2025
Review Date 05/09/2027

Purpose

The purpose of this SOP is to define the process for obtaining, maintaining, and managing import licenses for investigational products (IP) and biological samples for use in clinical trials conducted in Brazil. This ensures compliance with ANVISA regulations and Brazilian customs laws, while safeguarding supply chain integrity and trial continuity.

Scope

This SOP applies to all sponsor-initiated clinical trials in Brazil that require the importation of investigational medicinal products (IMPs), comparators, placebos, and biological samples for analysis. It covers license applications, renewals, customs clearance, CRO/vendor responsibilities, and documentation archiving. It applies to sponsors, investigators, CROs, and regulatory affairs teams.

Responsibilities

  • Sponsor: Ensures valid import licenses are obtained before shipment of IPs or samples.
  • Regulatory Affairs (RA): Prepares and submits license applications to ANVISA and coordinates renewals.
  • Logistics Manager: Ensures shipments are aligned with import permits and maintains supply chain records.
  • Principal Investigator (PI): Confirms receipt of imported materials at site and ensures storage per protocol.
  • Quality Assurance (QA): Audits import license documentation for inspection readiness.
  • CRO: Supports application and manages interactions with customs when delegated.
See also  SOP for Biological Sample Collection and Processing

Accountability

The Sponsor’s Head of Regulatory Affairs is accountable for ensuring compliance with import license requirements. The PI is accountable for proper handling and documentation of imported trial materials at the site.

Procedure

1. Pre-Import Assessment

  1. Determine whether investigational products or samples require import licenses under ANVISA rules.
  2. Document requirements in Import Assessment Form (Annexure-1).

2. License Application

  1. Prepare application dossier including protocol, IP details, MSDS, GMP certificate, and import justification.
  2. Submit dossier electronically to ANVISA.
  3. Record application details in Import License Submission Log.

3. Customs Clearance and Shipment

  1. Ensure shipments align with approved license and contain correct labeling.
  2. Maintain Import Shipment Tracker with details of customs clearance dates, reference numbers, and responsible parties.

4. Renewal of Licenses

  1. Monitor expiry dates of licenses and initiate renewal process 60 days before expiration.
  2. Submit updated protocol and supply chain details if required.

5. Documentation and Archiving

  1. File import permits, customs clearance receipts, and correspondence in TMF.
  2. Archive records for 15 years or per ANVISA requirements.

Abbreviations

  • ANVISA: Agência Nacional de Vigilância Sanitária
  • IP: Investigational Product
  • IMP: Investigational Medicinal Product
  • MSDS: Material Safety Data Sheet
  • PI: Principal Investigator
  • RA: Regulatory Affairs
  • QA: Quality Assurance
  • TMF: Trial Master File
  • CRO: Contract Research Organization

Documents

  1. Import Assessment Form (Annexure-1)
  2. Import License Submission Log (Annexure-2)
  3. Import Shipment 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 Assessment Form

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

Annexure-2: Import License Submission Log

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

Annexure-3: Import Shipment Tracker

Date Protocol No. Shipment No. Customs Ref Status Owner
20/08/2025 BRA-2025-01 IMP-2025-07 CUST-5678 Cleared Neha Sharma

Revision History

Revision Date Revision No. Revision Details Reason for Revision Approved By
28/08/2025 1.0 Initial SOP for import licenses of investigational products and biological samples. New SOP created for ANVISA compliance. Head of Clinical Research

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