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Using the online RCM application form

Print version

ARGCM Part D: Registered complementary medicines

29 October 2017
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If you want to print all entries, you need to Open all before you print.

Data entry and field types

If you haven't used one of our online forms before, this guide will introduce you to the different field types that are used, and how to save, edit and validate application forms.

Fields that have a red asterisk* against them are mandatory, and fields that have a grey asterisk* against them are 'required under certain conditions'.

You can leave some fields blank while drafting a new application, and save the draft to finish later. However, be aware that the form will not validate (and therefore, it cannot be submitted) until all mandatory fields have been completed.

Radio Buttons are used when only one option may be selected, for example:

Screenshot showing example of a 'Yes/No' radio button.

A drop-down list allows the user to select one choice from a list.

Screenshot of a drop-down list.

Only enter numbers in this field, and do not enter negative numbers. Decimal points are acceptable if required. In many cases, there will also be a drop down menu next to the quantity field to select the relevant unit of measurement.

Screenshot of numeric field with drop down menu to select unit of measurement.

You can type (or paste) text in these fields:

Screenshot of a 'Free text' entry field.

If the text exceeds the amount displayable in the text box, a vertical scroll bar will appear so you can move the text up and down to view, however if text reaches the field limit no further input will be possible.

Check boxes are used when more than one option may be selected from a list. Clicking a check box may open up additional fields or sub-forms you will need to complete. For example:

Screen shot showing pop-up box that includes a list of check boxes.

The application form has various fields to enter additional details by selecting the Add button where available, and entries within the form can be removed by selecting the check box next to that entry and then selecting the Remove button.

Screenshot highlighting the Add and Remove buttons.

Form layout

The top right of the application form displays:

  • the Application ID (generated when the form is first saved)
  • status of the form (e.g. Draft)
  • a client reference 'free text' field (for the sponsors' use, and not visible to TGA).
Screen shot showing position of application ID, status of the form, and client reference field.

There are seven (7) tabs that make up the application form: Application, Registration, Manufacturers, Products, Supporting Information, Other Regulatory Requirements, and Changes Made.

These are located from the top left of the form, and you can navigate through the form by clicking on the individual tabs.

Screen shot showing the seven information tabs that make up the application form.

The action toolbar is located at the bottom right of the form, and is described later in this guide.

Screen shot showing the action toolbar for the application form.

Saving a draft

You can save a draft notification at any time by selecting Save at the bottom right of the application form screen. We recommend you save the application at regular intervals, to ensure no ongoing work is lost.

Screen shot showing position of save button on application form.

When the application form is first saved, an Application ID is generated and will be displayed at the top right of the application form.

Screen shot showing position application ID when generated.

Editing a draft

You can edit your drafts at any time prior to submitting them.

You can see a list of the drafts you have saved in the Work in progress list. To open a draft, select Work on drafts in the My Work menu on the dashboard.

Screen shot showing where to access work in progress on TBS dashboard.

This will take you to the list of drafts for your organisation. Select the relevant entry on the list (for mouse users, a single click) to go to that draft.

Note: Don't select the small down arrow or information icon immediately to the left of each entry on the list. These have different functions.

Screen shot showing list of drafts for a user's TBS account.

If you have a lot of drafts on your list, you can filter it to make your draft easier to find.

For example, you can filter by Approval Area using the drop down list.

Screen shot showing different approval areas that can be selected to filter a list of draft applications.

Or, you can filter by Date, Identifier, Client Reference, Information, Class, or Status.

Screen shot showing other criteria that can be selected as a filter.

Validation

The application form must pass validation before it can be submitted. (We recommend that you save your draft before selecting validate.)

To validate the form, select Validate located at the bottom right of the form.

Screen shot showing validate button on application form.

The validation process checks that all compulsory fields are completed, and that information is entered in the correct format (e.g. email addresses).

If there are no validation errors, the status of the form (top right of window) will change from Draft to Passed Validation.

Screen shot showing application form status when validation is successful.

If the form won't validate, the status will remain as Draft, and you will be shown the fields you need to fix (and where you need to fix them) in a list which will appear on the right hand side of the form.

Selecting each error on the list (double click for mouse users) will take you to the field that you need to correct.

Screen shot showing examples of possible validation errors in an application form.

Once you have corrected these fields, you should save the form before trying to validate again. Further validation checks may uncover additional errors that need attention.

If you have issues with your application, you can contact the TGA by email: complementary.medicines@health.gov.au or by phone: 1800 020 653.

Printing, deleting, and copying

You can print the application form at any time before or after submitting it.

From the Drafts list, select the drop down arrow located at the far left of each draft, and then select Print Preview from the list.

Screen shot showing where to access the print preview for a draft application.

From the View Lodged Submissions list, select the drop down arrow as above, and then click Print Preview.

Screen shot showing where to access the print preview for submitted applications.

You will then see a preview of the draft or submission you want to print, and you have the option to either print or close the window.

  • Pressing Print brings up the printing options on your computer.
  • Pressing Close takes you back to the list.

You can delete a draft application at any point up until the time you submit it.

To do this, select View Drafts near the top of the Portal menu.

Select the drop down arrow (located at the far left of each entry – it will turn green when selected), then select Delete.

Screen shot showing where to locate the delete function for a draft application.

You will be asked to confirm that you want to delete the draft.

Screen shot showing pop-up box asking to confirm deletion.

Select the OK button if you wish to proceed, or Cancel to go back to the Drafts list.

You can copy any draft application form to create a new draft. Information from the copied draft is retained for every field.

Go to the draft list, located via the View Drafts link in the Portal menu.

Select the drop down arrow located at the far left of the listing, and then select Copy. A dialog box will ask if you are sure you want to copy this draft notification.

Screen shot showing pop-up box asking to confirm copying.

Selecting OK creates a new draft application form, and selecting Cancel takes you back to the Drafts list.

Submitting

Tip

It may be worthwhile making a copy of your application before submitting it.

This would be useful in cases where you need to temporarily withdraw an application, as doing so removes all the originally submitted information and you would otherwise have to start filling in a new application from scratch.

Once validation is successful, the Submit button will fully display in the action toolbar.

Screen shot showing location of submit button in action toolbar.

Selecting Submit will first take you to the Declaration page. The full text of the Declaration can be found below.

Screen shot showing declaration.

Selecting Disagree will take you back to the application form.

Selecting Agree takes you to the next submission step, which allows you to:

  • confirm basic submission details
  • add any extra comments or instructions
  • see the total fee (application + evaluation fee)
Screen shot if agree is selected after declaration, showing summary and where special comments can be inserted.

Once completed, select Submit (bottom right hand corner of the form), and you will be taken to a final checklist to confirm some basic administrative information.

Screen shot checklist which appears if you press submit after agreeing to declaration.

If everything is correct, select Submit again (bottom right hand corner of the form), and your application will be submitted to us.

A notification page then displays which:

  • confirms a successful submission
  • provides your submission number
  • gives instructions for printing your invoice

View lodged applications

From the dashboard view, there are two ways to get to your submissions list:

  • Select View submissions from the My work menu
  • Select the Submissions tab in the Work in progress list, then select View all submissions
Screen shot showing locations to view submissions.

If you are in the eBS view, select View Lodged Submissions in the Portal menu on the left of the screen.

Screen shot showing how to view submissions if in the older electronic Business Services (eBS) menu.

Any of these will take you to the list of submissions for your organisation. Select the relevant entry on the list (for mouse users, a single click) to go to that application.

Note: Don't select the small down arrow or information icon immediately to the left of each entry on the list. These have different functions.

You can filter the list in the same ways as described in Filtering your selection (Editing your draft section).

Withdrawing a submission

If you wish to withdraw an application, go to your Submissions list and select the down arrow to the left of the relevant entry.

Then select Withdraw from the available options.

Screen shot showing where to withdraw a lodged submission.

You will be asked to confirm if you want to withdraw the submission. Select the OK button if you wish to proceed, or Cancel to go back to the submissions list.

Screen shot showing prompt to confirm withdrawing a submission.

If you select OK, the Workflow Status for that entry will have 'Withdrawal Requested' added.

Screen shot showing withdrawal requested under workflow status.

Full text of Declaration

The product names stated on the labels of the therapeutic goods which are the subject of this application are:

Product Name:

Sponsors Business Name:

Sponsors Business ID:

I ..................... being a person authorised to make this application hereby certify that:

The information supplied in this application and all supporting data supplied to the TGA in connection with this application, or as revised by TGA and presented here for my verification, is current and correct.

Any Category C ruminant ingredients included in this product have been 'self-assessed' in accordance with the TGA's "Supplementary requirements for therapeutic goods for minimising the risk of transmitting transmissible spongiform encephalopathies (TSE's)" and comply with those requirements.

I note that the Therapeutic Goods Act 1989 provides penalties for making statements that are false and misleading in connection with an application for registration of therapeutic goods.

Assurances

I hereby declare by clicking on the 'AGREE' button below that the information given in this application and the above statements on this declaration form are current and correct.

Full name of signatory:

Date: