Reminder: Planned process improvements for GMP Clearance

18 September 2017

Introduction

TGA are planning to implement a number of process improvements for GMP Clearances in September 2017.

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' to save a PDF copy of your draft application to refer to later.

On Tuesday 19 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 26 September will need to be submitted as a new application or variation application using the redesigned application forms.

To locate 'draft' applications, follow these instructions: Planned process improvements for GMP clearance.

Please contact the Manufacturing Quality Branch if you have any questions.

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