Requesting Reinstatement of a Cancelled ARTG Entry – TGA Process

Overview of Reinstatement

A cancelled ARTG entry means the therapeutic good is no longer authorised for import, export, or supply in Australia. Reinstatement allows the entry to be restored without requiring a completely new application, provided the cancellation was voluntary (sponsor-initiated) and the product still complies with all applicable regulatory requirements at the time of request. This process is not available for entries cancelled by TGA action (e.g., for safety or compliance failures). Source: Request to reinstate an ARTG entry - TGA

Eligibility Criteria

Reinstatement may be considered if:

• The original cancellation was voluntary (not TGA-initiated).
• The therapeutic good remains unchanged or any changes have been appropriately notified/approved.
• All current regulatory obligations can be met (e.g., quality, safety, efficacy/performance evidence, labelling, post-market surveillance).
• There is a demonstrated need to resume supply (e.g., clinical demand, no suitable alternative).
• The request is submitted by the sponsor recorded at cancellation or a successor entity.

TGA assesses each request case-by-case; reinstatement is not automatic.

Application Process

1. Prepare Justification:

   • Explain the reason for original cancellation and why reinstatement is now sought.
   • Confirm no material changes to the product since cancellation (or detail approved changes).
   • Provide evidence of ongoing compliance (e.g., current GMP/manufacturing certification, updated risk management if applicable).

2. Submit Request:

   • Use the Request to reinstate an ARTG entry form (available on the TGA website).
   • Include:
     • Cancelled ARTG entry number(s).
     • Detailed justification and supporting documents.
     • Sponsor details and declaration of compliance.
     • Proposed effective date for reinstatement.
   • Submit via the TGA eBusiness Services portal or as directed.

3. TGA Assessment:

   • TGA reviews for completeness, compliance status, and public health considerations.
   • Additional information or updated documentation may be requested.
   • Processing time varies but is generally within several weeks to months, depending on complexity.

4. Outcome:

   • If approved, the ARTG entry is reinstated with the original or updated details.
   • The entry becomes active again, allowing lawful supply from the effective date.
   • Sponsors receive written confirmation.

Important Notes

• No Guarantee: Reinstatement is at TGA discretion; significant changes or new safety concerns may require a full new application.
• Fees: A fee applies for reinstatement requests (check current schedule).
• Supply During Processing: Supply remains prohibited until reinstatement is effective.
• Multiple Entries: One request can cover multiple related ARTG entries if justified.
• Post-Reinstatement: All standard post-market obligations resume immediately.

Detailed instructions, the official reinstatement request form, required supporting documents, fee information, and examples of acceptable justifications are provided in the TGA guidance on requesting to reinstate an ARTG entry. Source: Request to reinstate an ARTG entry - TGA

This mechanism supports flexibility for sponsors while maintaining rigorous oversight of therapeutic goods in the Australian market.