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

In July 2017, the TGA launched a new e-form for prescription medicines variations to replace six paper forms. The variations that can be requested with the Variation e-form are those that do not require evaluation of clinical or bioequivalence data.

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

On this page: Process questions | Notifications process | Validation errors and warnings | What's next?

Process questions

Which variations can be requested using the e-form?

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)
• Extension of indications to align with a reference product

See guidance on variations to prescription medicines - excluding variations requiring of clinical or bioequivalence data for further information on these variation categories.

Can I nominate changes to more than one product in the same request?

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.

Is the draft number my submission number?

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.

What happens if I pick the wrong variation type?

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).

Can I withdraw variation applications?

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 AST.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.

How can I submit my dossier to the TGA?

You can attach your data or supporting information to the e-form, in a single zip file in eCTD or NeeS format 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'. Your data will then be uploaded onto Docubridge by the TGA. You do not need to also send it in to eSubmissions.

Alternatively you can send your dossier in separately, in a single zip file in eCTD or NeeS format. 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). This should not be confused with a cover letter that you include within Module 1 of your dossier.

How do I get invoiced?

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.

When can I send in a paper application?

In special circumstances, a paper form may be submitted to the TGA for a 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.

Are there still SARs?

Yes. Only a subset of SAR change types can now be notified. Refer to guidance on variations to prescription medicines - excluding variations requiring of clinical or bioequivalence data for further information on which changes are classified as notifications.

When do I need to notify the TGA of my notifiable change?

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.

How long does it take to process a notification request?

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

If you have any other questions or problems with the e-form, please contact us AET.application.entry.team@health.gov.au

I am getting manufacturer validation errors or warnings. What should I do to resolve these?

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, where possible. We have since also launched functionality to allow applicants to resolve remaining manufacturer error messages.

From December 2017, all nominated manufacturers are displayed in the e-form. This means that you can update the information to resolve error messages that would otherwise prevent you submitting the e-form. This could be either missing clearance numbers or clearances which have expired dates recorded (even when the clearance has been renewed with the Manufacturing Quality Branch of the TGA).

If you are making changes to manufacturers in your application and you receive a manufacturing validation error, you should first remove the incorrect information. Then, add the correct manufacturer information/clearance to the e-form, which will populate the ARTG entry with the relevant GMP reference and associated information. You do not need to select another variation type to update this information - you can make these updates under any manufacturing variation type.

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.

My manufacturer clearance has expired or is about to expire. What should I do?

We encourage sponsors to renew their existing clearance where possible. If you don't have a new or renewed clearance yet, then refer to the GMP clearance guidance and the Clearance Application Assistance Tool.

If you have a new clearance ID and are making changes to manufacturers in your application, you can remove the expired clearance and add the new one by removing the entry and re-loading it. You do not need to select another variation type to update this information – you can make these updates under any manufacturing variation type.

I am getting a message indicating that my manufacturer does not have a GMP reference but I know that there is a licence or current clearance. What should I do to resolve this?

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. You do not need to select another variation type to update this information - you can make these updates under any manufacturing variation type.

Why do I get a message saying 'No entry found' when I try to add a manufacturer to my ARTG entry?

Please check that you have entered the correct ID for the manufacturer and also that the clearance has not expired. Once these have been established, please ensure that the clearance has been issued to you and not a previous sponsor. If you still have the error message, it may be due to an underlying data issue. In this case, please contact us AET.application.entry.team@health.gov.au.

I am getting an 'Unknown is an invalid container closure' message. What should I do to resolve this?

This message will not stop you from 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.

Will my Print Preview validate within my e-submission?

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.

Why does the status of my variation no longer change in my eBS portal?

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.

How can I fix the 'Quality Control' warning?

'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.

Why can I not amend the additional shelf life information?

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.

I have a change that results in a separate and distinct good (a s.23 Category 3 request) but I want to make other changes to the new goods as well. Can I do this in one transaction?

No. You must create the new goods and then once these are on the ARTG, you can request a variation to the new goods.