Prescription medicines minor variations e-form: Frequently asked questions (FAQs)

4 December 2017

In July 2017, the TGA launched a new e-form for prescription medicines minor variations to replace six paper forms.

Below are answers to some frequently asked questions to assist stakeholders in using this e-form.

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Process questions

Only applications that do not contain clinical or toxicology data for evaluation can be submitted using the e-form. The different application categories are as follows:

  • Correction of Error Request under 9D(1)
  • 9D(2C) Notifications
  • 9D(2) Safety-Related Request (SRR)
  • 9D(2) Safety Related Request with Data
  • 9D(3) Self-Assessable Request - Minor editorial change to the PI: with no evaluation of data (MEC)
  • 9D(3) Self-assessable request (SAR): quality changes
  • 9D(3) Category 3 request
  • s.23 SAR (that creates a separate and distinct good)
  • s.23 Category 3 request (that creates a separate and distinct good).

See guidance on minor variations to prescription medicines for further information on these minor variation categories.

Yes, as long as the products have exactly the same active ingredient(s). This includes the salt or hydration state of the substance(s).

Under the old (paper form) process, you could include products with similar active ingredients, for example risedronate sodium hemipentahydrate and risedronate sodium, in the same request. The e-form does not provide for this. If you believe that the active ingredients should be identical you will need to submit a correction of error request under Section 9D(1). Otherwise you will need to make separate requests, completing and submitting the e-form for each request.

No, the number you see while drafting your application contains the letters 'MV' and is not your submission number. Your submission number(s) are allocated after the e-form is submitted to the TGA. The best place to get the submission number(s) is from your lodged submissions view.

Your submission number(s) are now also displayed on your Print Preview fees table, after the request has been submitted to the TGA.

Before lodgment: You can amend your request at any time before you submit the e-form.

After lodgment: In some situations, you can request withdrawal of the variation application (see below).

Some variation applications can be withdrawn after they have been submitted. The applicant should formally request withdrawal of their variation application via an email to the Application Support Team. Emails should be sent to AET.application.support.team@health.gov.au.

Notification requests cannot be withdrawn after they have been submitted. A further variation request is needed to reverse the change.

You can attach your data or supporting information to the e-form, in a single zip file with a maximum file size of 100MB. Include a copy of the validated Print Preview in Module 1.2.1 as the application. A validated Print Preview has a status of 'Passed validation'.

Alternatively you can send your dossier in separately. A cover letter will be available to you after your variations are submitted to the TGA. Include a paper copy of this cover letter with your electronic media as it has your submission number(s).

A copy of the invoice will be emailed to the applicant and can also be viewed in your eBS portal.

If you are an agent submitting on behalf of a sponsor, you can opt to have the invoice sent to the sponsor directly instead of to you.

In special circumstances, a paper form may be submitted to the TGA for a minor variation. Contact the Application Entry Team on AET.application.entry.team@health.gov.au to confirm situations where a paper form may be used.

Where a paper application is submitted to the TGA, do not also fill out the e-form, as this will create a duplicate submission.

Notifications process

The notifications process for prescription medicines was launched on 4 December 2017. This process is for variations where the safety, quality and efficacy of a medicine are not affected.

Yes. Only a subset of SAR change types can now be notified. Refer to guidance on minor variations to prescription medicines for further information on which changes are classified as notifications.

The notifications process is a 'Tell and then Do' process. This means that you must submit your notification request, pay your fee and receive your acknowledgement email before you implement the change.

Following full payment of the fee, the system will automatically send through the acknowledgement email and update your ARTG entry. It may take up to 48 hours for the change to be visible on the ARTG.

Validation errors and warnings

Until recently, the TGA did not record GMP reference IDs in prescription medicine ARTG entries. This means that this information is missing from many entries. As part of the launch of the new e-form, the TGA undertook to match up and populate this information.

All nominated manufacturers are now displayed in the e-form. This means that you can update the information to resolve the error message that would otherwise prevent you submitting the e-form.

We encourage sponsors to note any warnings and resolve these when you are next varying manufacturing data. We will accept use of the paper/pdf form to resolve manufacturer issues in exceptional circumstances only. Please email AET.application.entry.team@health.gov.au if you believe you cannot resolve your manufacturing issues.

If you are making changes to manufacturers in your application and already have a new clearance, you can remove the expired clearance and add the new one.

If you don't have a new or renewed clearance yet, then refer to the GMP clearance guidance and the Clearance Application Assistance Tool.

We encourage sponsors to renew their existing clearance where relevant. Once approved, this will automatically update the clearance expiry date in affected ARTG entries.

If you are making changes to manufacturers in your application, you should remove the affected manufacturer. Then, add the manufacturer/clearance to the e-form, which will populate the ARTG entry with the GMP reference and associated information.

This message will not stop you submitting your application if it is displayed as a validation warning. However, if a validation error is displayed you will need to open up the container and shelf life and update the container closure by selecting the relevant value from the list.

When the e-form was first launched, the Print Preview was a secure PDF document which prevented validation of an e-submission. This issue has now been resolved and your Print Preview will validate.

When applications are submitted using the e-form, the status is 'Submitted'. Currently they remain with that status even when the evaluation stage has started. We are looking to update this in the coming months. Until then, the status of your variation can be viewed within the old Print Preview once the evaluation stage has started. Do this by viewing the events.

'Quality Control' is no longer a valid manufacturing step. The following manufacturing steps are to be used instead: 'Testing chemical', 'Testing chemical and physical', 'Testing microbial' and/or 'Testing sterility'. If you are making changes to manufacturers in your variation, you can edit the manufacturer steps accordingly.

The Additional shelf life information field within the e-form cannot be edited. If you need to amend the information, this can be done via the comments field of the variation that you are changing. You should include the current additional shelf life information and the amended wording that you intend to use.