Updates on GMP clearance application eforms

Fixes, including deactivation of 'New Draft Copy' button, will be effective 19 October 2018

11 October 2018

The TGA has been aware of some issues affecting a limited number of users after updates to the GMP clearance eForms in September 2017. Such issues include:

  • submitted applications or the evidence attached to an application were not visible to the TGA
  • minor display issues, for example spacing and alignment of text in the application form
  • validation errors associated with the use of the 'New Draft Copy' button

A fix for the above issues has been identified and is scheduled to be implemented 19 October 2018.

Further details and instructions relating to certain changes are mentioned below.

We appreciate your understanding and apologise for the inconvenience caused. If you have any questions or concerns, please do not hesitate to contact the GMP clearance section, Manufacturing Quality Branch.

Evidence attachments or applications not visible to the TGA

In the meantime, please continue to ensure you save and validate your application before submitting as per the GMP clearance guidance step-by-step instructions.

Deactivation of 'New Draft Copy' button

The 'New Draft Copy' button allows applicants to create an exact replica of an existing approved GMP clearance as a new draft application instead of manually entering details in a new form.

letter of access to clearance

It has been identified that applications drafted using this button presents a risk to the integrity of the data we currently collect and may result in validation issues when submitting a GMP clearance application.

For both new and variations applications, certain fields now automatically pre-populate, therefore removing the need for this button.

Given the issues identified and the current functionalities of the form, the "New Draft Copy" button will be deactivated.

Please note these changes will not apply to the Licensing and Certification application forms.

Reminder - Please make sure you submit your application correctly

Where submitting an application for a new GMP clearance, please ensure you refer to Step 4 - Creating your application of the GMP clearance guidance.

To maintain the validity of your GMP clearance, please ensure you submit a variation application as per Step 11 - Maintaining your active GMP clearance of the GMP clearance guidance.

If you wish to create a copy of a draft GMP clearance application:

  1. Click the dropdown arrow against the draft application
    • letter of access to clearance
  2. Click Copy
    • letter of access to clearance
  3. A new tracking number will be generated for the application and you can continue to edit the relevant fields as required.