New Submission
Sponsor Name
The Sponsor Name is automatically populated from your login details
Trade Name
The Trade Name is defined in the Regulations as the commercial name.

• given to goods of that kind by the manufacturer; and
• under which the goods are supplied.

Type of Submission
The Type of Submission is selected from the drop-down list. This must be populated prior to selecting the Common Active Ingredient
Category 1: If a sponsor is supplying evidence from Australian organisations to support their submission
Category 2: If a sponsor is supplying evidence from an overseas organisation to support their submission
Common Active Ingredient Name

1. Enter the common active ingredient name used in the application or click the Find Ingredients button
2. Select the Ingredient from the drop-down list
3. Click the OK button
4. Click the OK button

The Submission form checklist is displayed

Submission Details
Client Reference
The Client Reference field is the Sponsor's or Agent's own internal reference information. This reference information is not visible to TGA when the form is submitted.

The Submission Details are carried forward from the Application form and cannot be edited when creating a submission.
Status
There are two different status for the submission, these statuses are automatically generated by the lodgement process:
Draft When an submission has first been created; and
Validated When the submission has all mandatory fields completed and the validation process completed.
Submission ID
The Submission ID is automatically generated when you select the Lodge button
Submission Name
The submission name displays if a Sponsor or Agent is lodging the submission and the Active Ingredient name
Submission Type
The Category that is selected on the application
Trade Name
The Trade Name that was entered on the application
Common Active Ingredient Name
The Common Active Ingredient Name that was entered on the application
Sponsor Name
The name of the Sponsor who created and is submitting the application

Applications
Submission Purpose
A general description as to what you are submitting
Applications
Multiple applications can pertain to the submission. Select a single application or hold down the CTRL key and select multiple submissions to submit.
Submission Fee Category
The submission fee is automatically determined depending on the Applications selected. If there are multiple submissions, the fee category is determined by the most expensive application.
Submission Checklist
The categories in the submission checklist are different depending on the submission type. This checklist is to determine that all areas of the submission have been addressed.
Select the appropriate answers to the questions. You must answer all questions before selecting to validate or lodge the submission.

Supporting Data
The supporting data section is where you add data to support your submission.
Will hardcopy supporting data be submitted?

No
1. If you do not have any supporting data select No.
2. Enter a brief reason for no supporting data
Yes

Will hardcopy supporting data be submitted as bound volumes/ring binders?

No
1. Enter the number of pages per module
Yes
1. Enter the number of Volumes, Pages and Copies per module

Electronic Documents
To add an attachment

1. Select Add Attachments
2. Enter the document title
3. Enter a document description
4. Select Browse to locate the document
5. Select the document and click Open
6. Click Attach

To remove an attachment(s)

1. Select the attachment(s)
2. Click Remove Attachment button

Contact Officer Details
The contact officer is the Sponsor or Agent's officer that TGA can contact regarding the submission(s)

Lodgement Wizard
Selecting to Lodge the submission form means that you have answered all the submission details questions and entered all the required information.

1. Select, open and edit a Submission from the list of submissions in the Draft and Validated Submissions view.
2. Click the Lodge button.

A Lodge Submission dialogue box is displayed advising you on the steps that you must complete before you can lodge the submission.

1. Click the Continue button.

The Lodge Submission Declaration dialogue box is displayed.
Before this submission can be lodged you must acknowledge the declarations by selecting Yes against each one. In future versions, some declarations may allow a Not Applicable response.

1. Click the Next button

The Fees and Payment dialogue box is displayed

1. Select the Payment Option
   100% or 75%
   The Fee is displayed in AUD (Australian Dollars)
   or Please Invoice (an option if the total fee is over $100,000)
   or Other
   • Enter the Amount and Reason (ie the reason that you had applied to have instalments approved).
2. Click the Next button
3. The Tax Invoice is displayed
4. Click the Next button
5. Click Print to print the Tax Invoice
6. Click Next

The Cover Sheet is displayed

1. Click Next
2. Click Print to print the Cover Sheet
3. Click Close
4. Submit a copy of the cover sheet signed by an authorised officer with the data you are providing.

A Lodge Submission dialogue box is displayed advising you that all required steps have been completed successfully.

1. Click the Finish button. A progress animation is displayed indicating that the lodgement is proceeding.