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Updates on GMP clearance application forms

Update on extended clearance scope and Letter of access delivery method

8 August 2018

Following updates to the GMP clearances forms, we are continuing to monitor and review them to ensure improved user experience. The TGA has become aware of the following issues, and fixes are scheduled to be implemented in August 2018.

If you have any questions, please do not hesitate to contact the Manufacturing Quality Branch.

Extension applications - API/Product details on extended clearances

The scope details were not being displayed once a GMP clearance had been extended. Please be aware this issue should not affect the lodgement of product submissions via the TGA Business Services (TBS) portal.

The fix for this issue will ensure the API/Product details tab is visible on extended clearances in your TBS portal. This will also apply to pre-existing extended clearances.

You can continue to submit extension applications as per Step 11 - Maintaining your active GMP clearance of the GMP clearance guidance.

Uploading a Letter of access

When using a Letter of Access (LOA), the application form allowed applicants to select 'LOA to Clearance' or 'LOA to Evidence' without further information required. This resulted in applications being submitted without any evidence and only a clearance tracking number, and subsequently resulted in delays to the processing of applications.

letter of access to clearance

To address this issue, the delivery method options will be restricted to 'Upload Evidence' when using a LoA to Clearance or LoA to Evidence. Applicants must select 'Upload Evidence' as the delivery method when using a LoA, and select the relevant LoA option against the required evidence items.

letter of access to clearance

If you do not submit the required or requested evidence, you may experience delays in the processing of your application and may not be issued a GMP clearance. Any fees you have paid may be forfeited as a result.

For further details on how to fill out the form where using a LoA, please refer to Step 6 - Providing your evidence within the GMP clearance guidance.