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

12 October 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

Prescription Medicines Minor Variation Applications that do not contain clinical or toxicology data for evaluation.  The application types are as follows:

  • Correction of Error Request under 9D(1)
  • 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.

When adding products to the e-form, your products need to have the same active ingredient; this also includes the salt component. Previously you could submit products together like risedronate sodium hemipentahydrate & risedronate sodium. 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 separate forms will be required incurring two separate fees.

No. The draft number that you see on your Print Preview is not your submission number. Your submission number(s) are allocated to you after your variations are submitted to the TGA.  The best place to get the submission number(s) is from your lodged submissions view.

Variation applications can still be withdrawn from the system. 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@tga.gov.au

You can email your dossier to eSubmissions@health.gov.au if it is less than 25MB with the submission number in the subject line.  Otherwise you will need to submit the data on electronic media.  You will also need to email eSubmissions if you require an eIdentifier.

A copy of the invoice will be emailed to the applicant and can also be viewed via your eBS portal. If you are an agent submitting on behalf of a Sponsor you have the ability to decide where the invoice is sent to (the Sponsor or the Agent).  Please include your invoice number when making payment.

If for some reason a paper application was submitted to the TGA, please do not fill out the e-form, as this will create a duplicate submission. We are encouraging all applicants to use the e-form for every variation.

Validation errors and warnings

  • Previously the TGA did not record GMP reference IDs against prescription medicine ARTGs. As part of the launch of the new e-form, the TGA undertook to match up and populate this information. However, there were some issues that we are working to resolve.
  • For example: until late September, there was a mismatch between some clearance IDs and sponsor details. This prevented some sponsors from submitting their variation. This issue has since been resolved.
  • A validation error or warning will appear if there is inaccurate or out-of-date manufacturing data within an ARTG entry. It will be displayed as an error when manufacturer information has been updated as part of your variation and it will require correcting before you can submit the variation.
  • Otherwise it will be displayed as a warning for sponsors to resolve with their next variation to manufacturers.

We encourage sponsors to note the warnings and resolve any manufacturing data issues as part of a single application, either through:

  • a SAR application using the relevant manufacturing variation types or
  • a 9D(1) correction application for any administrative corrections or
  • using the Category 3 'other' manufacturer variation types, including the details within the comments field.
  • Where other SAR changes are being requested and all manufacturing issues cannot be resolved as part of a single application, include the details of the manufacturer changes within the comments field of the e-form and the covering letter. This will enable Applications Entry Team staff to update the relevant manufacturer information on receipt of the application.
  • We will accept use of the paper/pdf form to resolve manufacturer issues in exceptional circumstances only. Please email AET.application.entry.team@tga.gov.au if you believe you cannot resolve your manufacturing issues using the above options.

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 and will not require a variation application.

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

The Print Preview e-form has been created as a secure PDF document and currently does not pass validation. We are working to resolve this issue. Until the solution has been implemented you will be required to print the Print Preview e-form and scan it back into your dossier.  This will enable validation as required.

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 by viewing the events.

Quality Control is no longer a valid manufacturing step. If you wish to correct this warning, in your covering letter to the TGA, please indicate the relevant step(s) that will replace 'Quality Control'. Alternatively, 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 is not an editable field. 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.

What's next?

Improvements to the e-form

We have been listening to your feedback and are building additional improvements to the e-form. These are expected to be implemented in the coming months.

Notifications to prescription medicines

The TGA is also working on implementing a notification process for variations to prescription medicines where safety, quality and efficacy are not affected.

Anticipated implementation timeframes for this new process are available on the TGA website. This information will be regularly updated to let stakeholders know about the timing of next steps.