Standard Operating Procedure for Transfer of Marketing Authorization or Product License

Department	Regulatory Affairs
SOP No.	RA/2026/655
Supersedes	NA
Page No.	1 of X
Issue Date	10/04/2026
Effective Date	10/04/2026
Review Date	10/04/2028

Purpose

This Standard Operating Procedure (SOP) defines the systematic process for the transfer of Marketing Authorization or Product License between entities in compliance with applicable regulatory requirements. It aims to ensure controlled, traceable, and timely transfer activities that maintain product registration integrity, regulatory compliance, and uninterrupted market supply while mitigating risks associated with documentation, approval, and submission processes.

Scope

This SOP applies to all activities involved in the transfer or change of Marketing Authorization or Product License for pharmaceutical products. It covers regulatory affairs personnel, product registration records, documentation, communication with regulatory authorities, and collaboration with cross-functional teams including Quality Assurance, Manufacturing, and Legal departments. The scope includes national and international transfers, any dosage forms or therapeutic categories, and excludes transfers not involving regulated product licenses or marketing authorization changes.

Responsibilities

The following roles are involved in the execution and oversight of the transfer process:

• Regulatory Affairs Executive – Preparation and submission of transfer dossiers
• Regulatory Affairs Manager – Review and approval of transfer documents and correspondence
• Quality Assurance – Verification of compliance and documentation control
• Legal Department – Assessment of contractual and licensing implications
• Regulatory Head – Final approval and liaison with health authorities
• Project Coordinator – Tracking timelines and communication facilitation

Accountability

The Regulatory Affairs Head is accountable for the implementation and ongoing compliance with this SOP. This role ensures periodic review, manages any escalations arising during the transfer process, evaluates SOP effectiveness, and enforces corrective actions to maintain regulatory alignment and continuous improvement.

Procedure

1. Preparation and Prerequisites
Identify the need for transfer initiated by business strategy or regulatory requirements. Gather all relevant product information including current Marketing Authorization dossiers, license certificates, regulatory correspondence, and existing commitments with authorities. Confirm the identity and regulatory status of the receiving entity.

2. Regulatory Assessment
Review regulatory frameworks of involved regions to identify mandatory documentation, fees, timelines, and authority-specific requirements. Determine if any supplementary data, stability studies, or variations are necessary to support transfer. Conduct risk assessment on impact to market supply and compliance.

3. Document Compilation
Assemble the transfer package including transfer request letter, updated product information, full product dossier, certificates of compliance, and completed application forms. Ensure that all forms are filled according to the receiving authority’s guidance. Maintain traceability of authorized signatures and document version control.

4. Internal Review and Approvals
Circulate compiled documents for multi-level review and approval within Regulatory Affairs, Quality Assurance, and Legal departments. Address queries or non-conformities identified during reviews. Obtain formal sign-off per organizational authorization matrix prior to submission.

5. Submission to Regulatory Authorities
Submit the transfer dossier to the relevant regulatory authorities by designated communication channels (e.g., electronic submission, courier). Secure acknowledgments and confirmation receipts. Monitor progress and respond promptly to any regulator queries or requests for clarification.

6. Post-Submission Follow-up
Track the review status regularly and document correspondence until final approval is granted. Coordinate with authorities for inspections or audits if required. Communicate status updates to stakeholders and prepare for any required labeling or packaging updates reflecting transfer.

7. Record Retention and Closure
Upon completion, archive all transfer documentation as per regulatory record retention policies. Document the closure status in internal systems and notify involved departments. Conduct a post-transfer review meeting to evaluate process adherence and identify improvement opportunities.

Adherence to Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), and confidentiality throughout the procedure is mandatory. Any deviations must be reported and managed through the established deviation control process. All communications and actions must be documented accurately to support audit readiness.

Abbreviations

MA – Marketing Authorization
RA – Regulatory Affairs
GMP – Good Manufacturing Practice
GDP – Good Documentation Practice
QA – Quality Assurance
SOP – Standard Operating Procedure

Documents

The following documents are critical for the transfer of Marketing Authorization or Product License:

1. Transfer Request Letter (Annexure-1)
2. Regulatory Transfer Dossier Checklist (Annexure-2)
3. Authority Acknowledgment Receipt Template (Annexure-3)

References

1. International Council for Harmonisation (ICH) Guidelines
2. EMA and FDA Regulatory Guidance on Marketing Authorization Transfer
3. WHO Good Regulatory Practices
4. Internal Quality Management System Documentation
5. National Drug Regulatory Authority Regulations applicable to product license transfers

Version

1.0

Approval

Prepared By
Checked By
Approved By

Annexures

Annexure-1: Transfer Request Letter

Purpose: To formally request transfer of the Marketing Authorization or Product License from the current holder to the receiving entity, ensuring clear communication with regulatory authorities.

To	[Name of Regulatory Authority]
Date	10/04/2026
Subject	Request for Transfer of Marketing Authorization / Product License
Product Name	Example Product XYZ
MA Number / License No.	ABC123456
Current MA Holder	Company A
Receiving Entity	Company B
Reason for Transfer	Business restructuring and regional affiliate alignment
Attachments	Transfer Dossier, Compliance Certificates, Application Forms

We hereby request the transfer of the Marketing Authorization for the above-mentioned product as per the attached documentation and applicable regulatory frameworks. Please find enclosed all necessary documents for your review and approval.

Sincerely,

Regulatory Affairs Department
Company A

Annexure-2: Regulatory Transfer Dossier Checklist

Purpose: To ensure all required components of the transfer dossier are complete and submitted to regulatory authorities to facilitate approval.

Document Description	Included (Yes/No)	Comments
Transfer Request Letter	Yes	Signed and dated
Product Dossier (CTD format)	Yes	Full updated submission
Current Marketing Authorization Certificate	Yes	Original valid certificate
Quality Compliance Certificates	Yes	GMP compliance included
Application Forms	Yes	Fully completed and signed
Legal Documentation/Contract Copies	Yes	Included as per internal requirement
Fees and Payment Receipts	Yes	Payment confirmed

Annexure-3: Authority Acknowledgment Receipt Template

Purpose: To document receipt confirmation of the Marketing Authorization or Product License transfer application by the regulatory authority.

Authority Name	[Regulatory Authority Name]
Application Number	TR-2026-000123
Date Received	15/04/2026
Product Name	Example Product XYZ
MA Number / License No.	ABC123456
Applicant Name	Company A
Contact for Correspondence	Regulatory Affairs Section
Remarks	Transfer application accepted and under review
Signature / Stamp	_________________________

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
10/04/2026	1.0	Initial issue	New SOP creation