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Planned process improvements for GMP Clearance

15 August 2017

As part of the TGA's ongoing efforts to improve its processes and guidance to industry, we will be publishing an updated revision of the GMP clearance guidance document shortly. The updated guidance aims to provide clarification of the existing requirements for the GMP clearance process. We will also be publishing a new web-based GMP Clearance Application Assistance Tool (CAAT) to provide further assistance to sponsors prior to submitting GMP clearance applications.

In parallel to the above activities, we are also redesigning the current GMP Clearance application e-forms. The redesigned e-forms aim to:

  • Improve the user experience by:
    • Displaying a list of evidence required based on the application type selected
    • Pre-populating some data using client details already registered with TGA
    • Reducing duplication in data entry for applicants
    • Providing an improved 'Help' function within the e-form
  • Allow upfront payment of all relevant GMP Clearance fees
  • Allow extension requests to be submitted via the TGA Business Services GMP clearance application e-form

We aim to publish the updated revision of the guidance, CAAT tool and the redesigned e-forms in September 2017.

We plan to hold a number of GMP Clearance information sessions in early September. These sessions will provide an update on improvements to the GMP clearance guidance, redesign of the current GMP clearance e-forms and will also showcase the new CAAT tool to provide greater assistance to sponsors prior to submitting GMP clearance applications.

Important information

  • Ensure you don't lose existing work; you will need to submit any 'draft' GMP Clearance applications using the current form, before the redesigned GMP Clearance application forms go live.
  • There will be a planned outage of the GMP Clearance application forms from 09:00 (AEST) Tuesday 19 September to 09:00 (AEST) Tuesday 26 September 2017. You will not be able to submit GMP Clearance, Licence or Certification applications via tBS, during this time. If the application forms are available earlier, we will update you via our website.
  • If you need to submit a GMP Clearance, Licence or Certification application, please ensure that it is lodged by 18 September by 5pm (AEST). Alternatively, please plan to lodge your GMP Clearance, Licence or Certification application from 09:00 (AEST) on 26 September 2017 onwards.
  • There are no changes to the GMP Licence or Certification application forms.

For existing (in progress) applications

  • Applications submitted up to and including 18 September 2017 at 5pm will not be affected by the changes.

What you need to do with your draft GMP Clearance applications

As a result of the updated e-forms, to ensure you don't lose existing work you will need to submit any 'draft' GMP Clearance applications using the current form, before the redesigned GMP Clearance application forms go live. You may also use the "View entire application button" Screenshot: View Entire App button to save a PDF copy of your draft application to refer to later.

On Tuesday 19th September 2017 at 9am, any existing GMP Clearance drafts not submitted will be removed and no longer visible in your tBS portal.

All GMP Clearance applications from 26th September will need to be submitted as a new application or variation application using the redesigned application forms.

To locate 'draft' applications: Login to your TGA Business Services portal, under Work in progress, select view all drafts

Screenshot: highlighting how to locate draft applications through the Work in progress then View all drafts

This will direct you to a list of all your draft applications. Enter CL as a filter on identifier and select Go.

Screenshot: Highlighting enter CL as a filter on identifier and select Go

This will display a list of any draft GMP Clearance applications. You can continue editing a draft and submit by selecting the draft you want to edit.

Screenshot: Showing the list of any draft GMP Clearance applications

This will open the draft for editing, once all information is completed and the application successfully validates you can submit the application.

Screenshot: Highlighting the Validate and Submit buttons

We would also encourage you to delete any 'draft' GMP Clearance applications which are no longer required. To do this, Click on the drop down next to the draft application you want to delete. This will bring up an option box below. Select Delete

Screenshot: Highlighting the Drafts drop down box icon and the delete button

You will be asked to confirm that you want to delete this draft. Select OK to delete.

Screenshot: Highlighting the OK button

We will provide additional updates in the near future. Please contact the Manufacturing Quality Branch if you have any questions.

We appreciate your patience and understanding while we go through this transition.