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January 12, 2026
Approximately 5 minutes
Requesting Cancellation of an ARTG Entry – TGA Procedure
Requesting Cancellation of an ARTG Entry – TGA Procedure
Reasons for Requesting Cancellation
Sponsors may request cancellation of an ARTG entry for various reasons, including:
- The therapeutic good is no longer supplied or intended to be supplied in Australia.
- The product has been superseded by a new version or formulation.
- Commercial decisions to discontinue marketing.
- Resolution of compliance issues where continued inclusion is not viable.
- Other administrative or regulatory circumstances.
Cancellation is voluntary and initiated by the sponsor; the TGA does not automatically cancel entries unless required by law (e.g., safety concerns leading to compulsory cancellation). Source: Request to cancel an ARTG entry - TGA
Eligibility and Timing
- Any current sponsor (or authorised representative) of an ARTG entry may submit a cancellation request.
- Requests can be made at any time, but sponsors should consider:
- Impact on ongoing supply and patients.
- Transition arrangements for users.
- Stock run-down periods.
- The TGA typically processes requests promptly, but sponsors should allow time for the effective date to align with supply cessation.
Required Documentation and Submission
To request cancellation:
- Complete the Request to cancel an ARTG entry form (available on the TGA website).
- Provide:
- ARTG entry number(s) to be cancelled.
- Reason for cancellation.
- Proposed effective date of cancellation (usually at least 1–3 months to allow stock clearance).
- Confirmation that no further supply will occur after the effective date.
- Sponsor details and authorisation.
- For multiple entries, a single form can cover several ARTG numbers if related.
- Submit via the TGA eBusiness Services portal or as instructed on the form.
TGA Processing and Outcome
- The TGA reviews the request for completeness and validity.
- If approved, the ARTG entry status changes to cancelled.
- Cancellation is effective from the date agreed (or specified by TGA).
- Once cancelled:
- The product cannot be lawfully supplied in Australia.
- The entry remains in the ARTG database as historical record.
- Post-market obligations (e.g., vigilance reporting) continue for events related to prior supply.
- Sponsors receive confirmation of cancellation.
Important Considerations
- Supply After Cancellation: Supplying a cancelled product is illegal and may result in enforcement action.
- Stock Management: Sponsors should plan product withdrawal and notify supply chain partners.
- Patient Impact: For critical products, coordinate with healthcare providers.
- Fees: Cancellation requests are generally fee-exempt, but check current fees schedule.
- Irreversibility: Cancelled entries cannot be reinstated; re-inclusion requires a new application.
The TGA provides the official request form, step-by-step instructions, examples of valid reasons, and guidance on managing supply discontinuation in the page on requesting to cancel an ARTG entry. Source: Request to cancel an ARTG entry - TGA
This procedure supports accurate maintenance of the ARTG and enables orderly market withdrawal of therapeutic goods in Australia.
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