Changing the Sponsor of a Therapeutic Good in Australia – TGA Process

Overview of Sponsor Change

Under the Therapeutic Goods Act 1989, the sponsor is the entity legally responsible for the therapeutic good in Australia, including compliance with regulatory obligations, adverse event reporting, recalls, and maintaining ARTG entry information. Changing the sponsor requires a formal variation application to transfer these responsibilities to the new sponsor while ensuring no gap in accountability or supply. Source: Changing the sponsor of a therapeutic good - TGA

Types of Sponsor Changes

The TGA distinguishes between:

• Full sponsor transfer: Complete change from one sponsor to another (most common).
• Partial or administrative changes: Updates to sponsor name, address, or contact details without changing the legal entity.
• Merger/acquisition scenarios: Where the new entity inherits sponsorship due to corporate restructuring.

All changes must be notified and approved by the TGA before taking effect.

Process for Sponsor Transfer

1. Agreement Between Parties:

   • The current (outgoing) sponsor and new (incoming) sponsor must agree on the transfer.
   • A written agreement or deed of transfer is recommended to document responsibilities handover.

2. Variation Application:

   • The incoming sponsor submits a Sponsor Transfer Request variation via the TGA eBusiness Services portal.
   • Required documents typically include:
     • Sponsor Transfer Request form.
     • Evidence of agreement between sponsors.
     • Declaration from the incoming sponsor accepting all regulatory obligations.
     • Updated sponsor details and contact information.
     • Proof of incoming sponsor’s eligibility (e.g., Australian entity or authorised representative).

3. TGA Review and Approval:

   • TGA assesses the application for completeness and compliance.
   • Processing time is usually within 30 working days (shorter for administrative changes).
   • Upon approval, the ARTG entry is updated to reflect the new sponsor.

4. Effective Date:

   • The transfer takes effect on the date specified in the approval or the date the variation is processed.
   • The outgoing sponsor remains responsible until the effective date.

Post-Transfer Obligations

• The new sponsor assumes full responsibility for:
  • Maintaining ARTG entry accuracy.
  • Reporting adverse events and field safety issues.
  • Managing recalls and product defects.
  • Complying with advertising, labelling, and post-market surveillance rules.
• Both parties should coordinate handover of records, vigilance data, and any ongoing commitments.

Special Considerations

• Supply Continuity: The new sponsor must ensure uninterrupted supply; TGA may expedite processing if critical supply is at risk.
• Fees: Sponsor transfer variations attract a fee (administrative changes may be lower or fee-exempt in some cases).
• Multiple Entries: For sponsors with many ARTG entries, a single variation can cover multiple products if clearly specified.
• Overseas Sponsors: Incoming overseas sponsors must appoint an Australian sponsor or act through an authorised representative.

The TGA provides detailed guidance, forms, fee schedules, checklists, and examples of required documentation for sponsor changes in the official page on changing the sponsor of a therapeutic good. Source: Changing the sponsor of a therapeutic good - TGA

This process maintains regulatory oversight and protects public health by ensuring clear accountability throughout the lifecycle of therapeutic goods in Australia.